Patient Assistance Programs:
Recent Enforcement, Current
Litigation and Evolving Practices

For the past several years, the Department of Justice and HHS Office of Inspector General have brought numerous enforcement actions against both pharmaceutical companies and copay assistance foundations alleging that donations by pharmaceutical manufacturers to copay assistance foundations flouted OIG guidance and violated the Anti-Kickback Statute. In the wake of the Government’s investigations, multiple qui tam actions have also been filed. The OIG has elaborated on and reinforced its position regarding charitable copay assistance through recent advisory opinions and corporate integrity agreements with both pharmaceutical companies and copay assistance foundations. In this enforcement environment, pharmaceutical manufacturers that seek to provide copay or other financial assistance to Medicare beneficiaries must tread carefully.

Meanwhile, the courts are now considering multiple challenges to the Government’s restrictive views on charitable copay assistance. And multiple Congressional committees are also considering the issue.

This program will outline legal risks and best practices for pharmaceutical companies providing charitable patient assistance, including donations to copay assistance foundations. It will also outline the OIG’s most recent positions as outlined in advisory opinions and corporate integrity agreements, and summarize the current litigation.

Top Ten Benefits:

What has the Government alleged in its settlements with pharmaceutical companies, copay assistance foundations and specialty pharmacy, related to charitable copay assistance?
Why did the OIG revoke the advisory opinion of a charitable copay assistance foundation?
What forms of patient assistance has the OIG approved – and what has it rejected – in recent advisory opinions?
What can pharmaceutical companies learn from the OIG’s corporate integrity agreements?
What are some dos and don’ts for pharmaceutical companies to keep in mind when providing copay financial assistance?
What are the Government’s latest enforcement theories regarding patient assistance?
What is the current state of litigation over donations to copay assistance foundations?
Have the courts agreed with the Government’s legal positions on copay assistance?
What has Congress had to say about patient assistance?
How might the 2020 election results affect the future of patient assistance?

SPEAKERS

[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/jessewitten-300x205.jpg' attachment='25587' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Jesse A. Witten

PARTNER, FAEGRE DRINKER BIDDLE & REATH LLP

Jesse Witten is a partner in the Washington office of Faegre Drinker Biddle & Reath LLP, where his practice focuses on defending health care providers and medical device and pharmaceutical companies in False Claims Act investigations and litigation. He also counsels clients on health care fraud and abuse compliance issues. Mr. Witten has devoted a great deal of time over the past several years to compliance and enforcement matters relating to pharmaceutical company patient assistance and copay assistance foundations. [/av_textblock] [/av_three_fourth][/av_section]

October 20, 2020/by Chiara Travisano

Webinar

Applying CSA Concept To Data Integrity – Updates on ISPE GAMP GPG DI & CSA Appendix

Applying CSA Concept To
Data Integrity – Updates on ISPE GAMP GPG
DI & CSA Appendix

There are two parts to this webinar:

CSA and data integrity GPG DI alignment
Insert more data integrity so we don’t bore people with CSA

Hear directly from the source, FDA – Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) By Design and the CSA Appendix. Attendees will gain insight into the importance of data integrity, and gain a complete understanding of the key requirements and essentials needed to address these ongoing challenges. Learn how to execute data integrity by design for the management of GxP regulated records and data, ensuring the completion, consistency, and accuracy throughout the process. Understand how CSA is transformative to streamline business processes with quantitative and qualitative analysis to optimize your organization’s operational performance.

Top Reasons to Attend:

Recent intensification of data integrity sanction by regulators
The value of avoiding the mistake of focusing on regulatory risk over the patient risk
How to remediate deficiencies or lack of controls
CSA can be applied for any risk management methodology and uses patient safety and product quality – data integrity as the common denominator
CSA concepts apply broadly to all validation for the intended use of a computerized system
Automation is supposed to improve data integrity and promote better use of data for the benefit of patient safety and product quality
CSA is the application of critical thinking and risk-based principles when developing a computerized system lifecycle strategy in support of data integrity
The applicability of direct and indirect risks to patient safety and product quality and data integrity

SPEAKERS

[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/09/Raechelle-Raimondo.jpg' attachment='25256' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Raechelle Raimondo

Executive Director – Global Systems Assurance, AbbVie (formerly Allergan)

Mrs. Raimondo is an experienced leader with over 20 years of Life Sciences industry experience in the implementation of compliant and business driven global systems using a risk-based approach. By applying strategic and critical thinking she has successfully established practical policies and practices for regulated & non-regulated computer systems to achieve quality business outcomes. In today’s rapidly changing world of technology, she has shifted her focus and passion to collaborate with others to effectively implement Computer Software Assurance (CSA) and automation tools within the pharmaceutical industry. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/senthil-e1579292396848.jpg' attachment='23972' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Senthil Gurumoorthi

MS MBA, Associate Director IT, Gilead Sciences

Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure & Platforms and manages IT Inspection and audit readiness program. He has over 16 years of diverse experience in biopharmaceutical business ranging from pre-clinical, R&D to manufacturing with leadership expertise on Quality Assurance, Risk Management, Inspection/Audit Management, and Vendor Management. Additionally, as certified Auditor conducted ISO and Part 11/Annex 11 Audits globally. He holds B.E in Electronics & Communication from PSG College of Technology, MS in Electrical Engineering from New Jersey Institute of Technology and Masters in Business Administration (MBA) from Imperial College London. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Ken-shitamoto-e1579292324780.jpg' attachment='24013' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Ken Shitamoto

MS, Sr. Director IT, Gilead Sciences

Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/Shana-Kinney-300x225.png' attachment='25463' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg=''] Shana Kinney Associate Director, Validation, REGENXBIO Inc.

Shana Kinney has over 14 years’ progressive experience in the biosafety testing, molecular diagnostic medical devices, and gene therapy industries. She has served as a validation engineer, quality engineer, software quality assurance, and computer systems validation engineer and is currently working at REGENXBIO Inc. as an Associate Director, Validation building a computer systems and equipment validation program for a rapidly growing startup. Shana is a co-author of the ISPE Good Practice Guide for IT Infrastructure and a member of the ISPE Val 4.0 Committee. She is certified by ASQ as a Six Sigma Green Belt, Software Quality Engineer, and Quality Engineer with a Bachelor’s degree in Applied Mathematics and Master’s in Applied Statistics. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/Khaled-Moussally.png' attachment='25435' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg=''] Khaled Moussally Head of Quality Management Systems

A Versatile global Quality / IT executive with over 25+ years of quality and compliance, experience in highly regulated life science industries (Medical Device, Bio-tech, Pharmaceutical and Tobacco). Deep understanding in the Manufacturing processes, Equipment validation and Lab Information Systems. Extensive background in Quality Management Systems, regulatory inspections and internal audits. Member of an FDA/Industry CSV Consortium, focusing on developing risk-based recommendation to reduce time and cost in validating software. [/av_textblock] [/av_three_fourth][/av_section]

October 16, 2020/by Chiara Travisano

Webinar

Fraud and Corruption Risks Tied to Domestic and Foreign HCP Interactions – Enforcement Trends and Key Risk Indicators

Fraud and Corruption Risks Tied to
Domestic and Foreign HCP Interactions -
Enforcement Trends and Key Risk Indicators

Recent enforcement actions under U.S. health care fraud and abuse laws and the U.S. Foreign Corrupt Practices Act (FCPA) underscore that interactions with health care providers (HCPs) can result in significant legal exposure for life sciences and health care companies. In this webcast, the presenters will address particular types of HCP interactions that the U.S. Department of Justice (DOJ), the U.S. Securities and Exchange Commission (SEC), and private whistleblowers have targeted in recent investigations, enforcement actions, and litigation. Among other HCP interactions, this webcast will focus on speaker bureaus, roundtable meetings, sponsorships, post-marketing observational studies, product support programs, clinical decision support activities, and the provision of free goods and samples. In light of the COVID-19 pandemic, the presenters will analyze how virtual meetings and telemedicine/telehealth activities are likely to impact the risk profile of many of these activities. This webcast also will address methodologies for identifying key risks associated with these types of interactions through risk assessment and data analysis activities. The presenters will cover particular steps that companies with nascent or mature compliance programs can incorporate data analysis to mitigate fraud and abuse and international anti-corruption risks.

Top Ten Benefits

The ways in which DOJ, the SEC, and whistleblowers apply the False Claims Act, Anti-Kickback Statute, and FCPA to routine interactions between HCPs and life sciences/health care companies;
Key areas of focus for DOJ, the SEC, and whistleblowers in False Claims Act, Anti-Kickback Statute, and FCPA enforcement actions and cases;
Novel DOJ, SEC, and whistleblower theories tied to historically accepted HCP interactions under the False Claims Act, Anti-Kickback Statute, and FCPA;
Exacerbating circumstances in enforcement actions based on HCP interactions (e.g., DOJ’s so-called “badges of fraud” in speakers fee and product support cases);
The evidence that DOJ and the SEC martial in pursuing enforcement actions tied to HCP interactions;
Defenses that companies can assert in defending legitimate HCP interactions;
The likely impact of the pandemic on HCP interactions and associated risks;
Supplemental compliance controls to mitigate new types of interactions resulting from work-from-home and pandemic-related restrictions;
Methodologies to identify fraud and abuse and anti-corruption risks in audits, monitoring, and data analytics; and
Practical data analysis strategies to mitigate risk.

SPEAKERS

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Winston Y. Chan

PARTNER, GIBSON DUNN

Winston Y. Chan is a former federal prosecutor and litigation partner in Gibson, Dunn & Crutcher’s San Francisco office. He has particular expertise leading matters involving government enforcement defense, internal investigations, compliance counseling, and civil trial litigation for life sciences clients. Mr. Chan is a LMG Life Sciences “Star” and a Chambers-ranked attorney in the category of White Collar Crime and Government Investigations, and Benchmark Litigation recognizes him as a Litigation Star for being “recommended consistently as a reputable and effective litigator by clients and peers.” Global Investigations Review ranks Mr. Chan in its annual Global Guide of Recommended Investigations Counsel, including in their inaugural ranking of “the most eminent lawyers in the field under 45.” Mr. Chan previously served as an Assistant U.S. Attorney in the Eastern District of New York, where he held a number of supervisory positions, including as Health Care Fraud Coordinator. In that capacity, he oversaw all qui tam and whistleblower investigations involving allegations of False Claims Act violations, kickbacks, misbranding and off-label promotion by pharmaceutical, biotechnology, and medical diagnostic companies, among others. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/Michele-Wiener-640x640-1-300x300.jpg' attachment='25537' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Michele Wiener

PARTNER, CONTROL RISKS

Michele Wiener is a Partner within Control Risks’ Compliance, Investigations and Technology practice, and head of its Regulatory Risk and Life Science groups in the Americas region. She has significant experience in fraud and corporate compliance matters in the US and abroad. Working on behalf of legal counsel, boards of directors, and senior management of public and private corporations, Michele specializes in conducting complex corporate investigations and forensic accounting engagements involving allegations of corruption, financial reporting fraud, internal controls and books and record-keeping violations under both the Foreign Corrupt Practices Act (FCPA) and UK Bribery Act. She has led engagements in more than 30 countries, including the US, Latin America, Europe, the Middle East, Africa, and Asia. Michele has also helped companies design, evaluate, and improve anti-corruption and anti-fraud compliance programs. In 2019, Control Risks’ Regulatory Risks and Investigations Team in the Americas, led by Michele Wiener, was named Compliance Consulting Team of the Year at the C5 Women in Compliance Awards. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/JPartridge_web.jpg' attachment='25540' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

John Partridge

PARTNER, GIBSON DUNN

John Partridge is a Chambers-ranked litigation partner in Gibson, Dunn & Crutcher’s Denver office and a Co-Chair of the firm’s FDA and Health Care Practice Group. His practice focuses on government and internal investigations, white collar defense, and complex litigation for clients in the life sciences and health care industries. Mr. Partridge, whom LMG has ranked as a rising star in life sciences, has particular experience with the False Claims Act, the Foreign Corrupt Practices Act, and the Federal Food, Drug, and Cosmetic Act, including defending major corporations in investigations pursued by the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC). Mr. Partridge has represented clients in criminal and civil enforcement actions relating to alleged health care fraud and abuse, including actions conducted by DOJ, the U.S. Food and Drug Administration’s Office of Criminal Investigations, the Department of Health and Human Services Office of Inspector General, and State Attorneys General. His substantive experience includes cases involving allegations relating to, among other things, clinical trials, off-label promotion, sampling practices, importation of regulated products, and anti-kickback issues. Among other publications, Mr. Partridge and his colleagues wrote the criminal enforcement and pharmaceutical sampling chapters of PLI’s Pharmaceutical Compliance and Enforcement Answer Book. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/RRector_web.jpg' attachment='25543' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Reid F. Rector

ASSOCIATE ATTORNEY, GIBSON DUNN

Reid F. Rector is a senior litigation associate in Gibson, Dunn & Crutcher’s Denver office. His practice focuses on litigation and government investigations for companies in the health care and life sciences industries, including health care and FDA compliance, enforcement, and related litigation. Mr. Rector has substantial experience representing health care, pharmaceutical, and medical device clients during investigations by the Department of Justice, the Food and Drug Administration, the Department of Health and Human Services Office of Inspector General, and State Attorneys General, including in-depth experience with the False Claims Act and Anti-Kickback Statute. He also regularly advises clients on FDA regulatory issues under the Federal Food, Drug, and Cosmetic Act. [/av_textblock] [/av_three_fourth][/av_section]

October 14, 2020/by Chiara Travisano

Webinar

Key Lessons You Need to Know from Enforcement Actions in the Life Sciences Industry in 2020 and the Outlook for 2021

Key Lessons You Need to Know from
Enforcement Actions in the Life Sciences
Industry in 2020 and the Outlook for 2021

The life sciences industry knows that government enforcement actions offer critical insights into emerging legal and compliance risks that may impact their business. In 2020, there were several key enforcement actions that are essential to know to ensure that your business operations continue to address operational risks. In this session, we will discuss key areas of government enforcement from key 2020 investigations and settlements, including areas of government scrutiny and legal theories underlying these actions. We will gleam insights from government complaints and settlement agreements, as well as OPDP enforcement letters. We also will discuss emerging trends in corporate integrity agreements arising from these matters, and discuss the outlook in industry enforcement for 2021.

Key Takeaways From this Session

Know the 2020 key enforcement actions in the life sciences industry
Analyze these recent enforcement actions to understand emerging areas of enforcement risk
Discuss the laws and causes of action relevant to key enforcement areas, including False Claims Act, Anti-Kickback Statute and Foreign Corrupt Practices Act
Understand the legal theories the government uses in these actions and how they relate to the areas of enforcement
Learn new trends in corporate integrity agreements with the HHS OIG
Consider ways to incorporate better industry practices into your risk mitigation strategy to address emerging risk areas
Identify ways to strengthen your company’s corporate compliance program

SPEAKERS

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Sarah K. diFrancesca

PARTNER, DINSMORE &. SHOHL LLP

Sarah K. diFrancesca is a partner in the Health Care & Life Sciences practices at Dinsmore & Shohl LLP. Sarah’s practice focuses on complex health care litigation, investigations, regulatory compliance, and fraud and abuse relevant to clinical-stage and commercial pharmaceutical, biotechnology, and medical device companies and clinical laboratories. Her experience includes defending health care and life sciences companies and individuals in criminal and civil False Claims Act investigations regarding complex government theories of health care fraud, false claims, misbranding, off-label promotion and kickbacks. This includes negotiating and implementing settlements and corporate integrity agreements, and advising clients on regulatory self-disclosures. Sarah also advises companies on the Anti-Kickback Statute, fraud and abuse laws, FDA and regulatory compliance matters, transparency laws, and industry codes of conduct. This includes conducting internal compliance investigations, advising on promotional practices, implementing and improving corporate compliance programs, compliance auditing and monitoring, and transactional diligences. Sarah counsels boards of directors, compliance committees, and management executives on compliance and regulatory issues. She also develops and conducts compliance training programs for sales representatives, promotional review committees, and management teams. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/10/BleiferSquareBW-300x300.jpeg' attachment='25488' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Craig Bleifer

PRINCIPAL, CRAIG B. BLEIFER LLC; former General Counsel for Novo Nordisk and Daiichi Sankyo

Craig Bleifer is the former general counsel for Novo Nordisk, Inc., and previously was the general counsel for Daiichi Sankyo, Inc. He is the principal of Craig B. Bleifer, LLC, a law and consulting practice focused on advising and counseling clients on healthcare industry topics. www.CraigBleifer.com Craig has over 20 years’ experience in the US and Global healthcare industry and nearly 30 years as an attorney. He is the Past Chair, PhRMA Law Section Executive Committee, and Past Chair, Healthcare Institute of New Jersey. He has been awarded General Counsel of the Year by NJBIZ, and was awarded In-House Legal Department of the Year by New Jersey Law Journal. Contact: craig@CraigBleifer.com. [/av_textblock] [/av_three_fourth][/av_section]

October 8, 2020/by Chiara Travisano

Webinar

Trouble Sleeping? What is Keeping In-House Counsel and Compliance Officers Up at Night

Trouble Sleeping?
What is Keeping In-House Counsel and
Compliance Officers Up at Night

A panel of leading in-house counsel and compliance officers will discuss how their roles have changed during the pandemic and the key legal and compliance issues keeping them up at night. This webinar will provide specific steps being taken to adjust to the new normal during and following the pandemic including a remote workforce and best practices for addressing primary risk areas such as data privacy. The panel has extensive experience in in-house legal and compliance roles and will offer valuable insights into how specific areas of their responsibilities have been affected by the pandemic such as information security, internal investigations, litigation, engaging with regulatory agencies, and employee engagement. This webinar is for attorneys and compliance personnel with any level of experience.

Top Ten Benefits

Hear first-hand from in-house legal and compliance officers about the impact of the pandemic on their distinct roles and responsibilities.
Learn how in-house legal and compliance officers are working together to minimize risk in the corporate world.
Panelists will discuss the top 10 issues that keep them up at night – domestic and global
Participants will receive detailed explanations of how to address the key risk areas and move forward with confidence.

SPEAKERS

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John E. Kelly

MANAGING PARTNER, BASS BERRY & SIMS

John Kelly is a former federal healthcare fraud prosecutor, experienced trial attorney, and Managing Partner of the firm’s Washington D.C. office. John represents companies and executives in internal investigations, government and congressional investigations, criminal prosecutions, and civil litigation in matters related to healthcare fraud and abuse including the False Claims Act, Anti-Kickback Statute, Stark Law, and Food, Drug and Cosmetic Act, as well as other regulatory and compliance issues. John has been selected to serve as outside compliance and investigations counsel to a number of health systems and life sciences companies, including some that are subject to reporting requirements under a CIA. John also has extensive experience in managed care conducting investigations and working with providers and plans to ensure compliant practices in the risk adjustment space. John is Chambers ranked and listed as one of Washington, D.C.'s Super Lawyers. John had a distinguished career as a federal prosecutor with the Department of Justice (DOJ) where he held a number of leadership positions, including:

Assistant Chief for Healthcare Fraud, Criminal Division, Fraud Section.
Lead Prosecutor, Medicare Fraud Strike Force, Los Angeles, CA.
Chief of Staff and Deputy Director of the Executive Office for U.S. Attorneys

John is a frequent speaker and writer on topics related to healthcare fraud and abuse. John is frequently quoted in national media outlets on compliance and government enforcement matters. His opinions have been published in articles by The Wall Street Journal, The Washington Post, Reuters, Bloomberg News, Modern Healthcare, Law360, and others. [/av_textblock] [/av_three_fourth][/av_section]

October 5, 2020/by Chiara Travisano

Webinar

Data-Based Process Monitoring, Control and Improvement: A Systematic Approach

Data-Based Process Monitoring,
Control and Improvement
A Systematic Approach

Process monitoring, control and improvement has been at the heart of quality management for decades. The methodology continues to develop and has moved into a new era with the widespread availability of online data collection systems. This development creates the need for better utilization of the collected data for process monitoring, control and improvement.

This presentation discusses some recent advances. The FDA’s 2011 Process Validation Guidance calls for “Continued Process Verification” (CPV). Process monitoring provides the tools for enabling CPV and dealing with variation. Managing and reducing variation is at the heart of the FDA Process Validation Guidance. Clearly stated in the guidance is the need to understand variation, ability to detect variation, understand the impact of variation and ability to control variation.

This session addresses the concepts, methods and tools used in process monitoring, control and improvement and in turn continued process verification. It is shown how the tools are integrated to create a DATA-BASED SYSTEM that links process monitoring, control and improvement. This system enhances the use of the tools and the effectiveness of continued process monitoring, control and improvement. The approach is illustrated with a variety of case studies including pharmaceuticals.

Top Ten Benefits – What the Attendees will Learn

Implementation of FDA Validation Guidance regarding Continued Process Verification (CPV)
Tools for assessing process control and capability
How to reduce process risk
How to reduce test method Risk
How to integrate statistical tools into a system for process monitoring, control and improvement (CPV)
How to identify and reduce “special causes” of variation
Common sources (“The usual suspects”) of process problems
Role of management in process monitoring, control and improvement
Process Control Strategy – Integrating use of process Stability and Capability Metrics
Tips and traps – What to watch out for

SPEAKERS

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Ronald D. Snee

Founder And President, Snee Associates, LLC

Ron Snee is Founder of Snee Associates, LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives, using Quality by Design, Lean Six Sigma and other improvement approaches. He is also an Adjunct Professor in the RAQA and pharmaceutical programs at Temple and Rutgers Universities. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceutical development. He is an Honorary Member of the American Society for Quality and has received numerous honors and awards for his research, consulting and publications. [/av_textblock] [/av_three_fourth][/av_section]

October 1, 2020/by Chiara Travisano

Webinar

Data Integrity Remediation – It is NOT a One-Time Activity!

Data Integrity Remediation:
It is NOT a One-Time Activity!

Abstract:

With release of Data Integrity guidelines from FDA, MHRA, EMA and other regulatory bodies across the globe, data integrity compliance received limelight across the industry since 2015. Looking at the trend of increase in warning letters on Data Integrity non-compliance, the industry jumped immediately into Remediation exercises to achieve compliance with the Data Integrity requirements. Will one time exercise of Data Integrity Remediation be sufficient to demonstrate compliance? Let us discuss on this webinar to see how periodic review, the critical step in Data Integrity Monitoring helps to achieve overall compliance.

Key Takeaways:

Understand the key steps to be performed post completion of Data Integrity Remediation exercise at R&D, MFG and QC Laboratories
How to conduct periodic review process?
Periodic Review Checklist template

Top 6 Reasons to Attend

You will have the opportunity to review the list of monitoring checks required to demonstrate Data Integrity compliance
You will gain knowledge on how to conduct periodic review exercise
Helps to establish a well-defined Data Integrity Program for your organization
Determine the cost and effort required to conduct this exercise at your organization
Access to the periodic review checklist that will help you to define the process/templates
Interact with the speakers and clarify your questions on Data Integrity / Periodic Review process

SPEAKERS

[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/09/Abhinaya-Rajasekaran.png' attachment='25269' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Abhinaya Rajasekaran

Head - Compliance & Validation Services, Zifo RnD Solutions

Ms. Abhinaya is a Compliance, Validation and Data Integrity Consultant who heads the compliance department at Zifo RnD Solutions. She has consulted pharma, biotech, medical device, diagnostics and product development companies in devising their qualification strategy. Having worked with several global GxP, Data Integrity and ERES requirements ranging from US, UK, EU, Asia pacific, she has expertise in understanding the dynamics, specifics and commonalities in global regulations to provide pragmatic solutions. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/09/Loganathan-Kumarasamy.png' attachment='25270' attachment_size='full' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Loganathan Kumarasamy

Head of US Compliance & Validation, Zifo RnD Solutions

Mr. Loga is responsible for managing validation and compliance services at Zifo RnD Solutions. He holds a Master’s degree in regulatory affairs from Northeastern University and RAPS RAC (US) certification holder since 2018. With in-depth knowledge of Part 11, EU Annex 11, HIPAA, data integrity principles and applicable GxP regulations for computer systems, medical devices and laboratory systems, he has been providing consultation for top pharmaceutical and product development companies. [/av_textblock] [/av_three_fourth][/av_section]

September 23, 2020/by Chiara Travisano

Webinar

A Moving Target: Adapting Risk Assessment and Mitigation Strategies to the COVID-19 Era

A Moving Target:
Adapting Risk Assessment and
Mitigation Strategies to the COVID-19 Era

Dynamic Risk Assessment and Mitigation Programs (“RAMP”) are a hallmark of effective compliance programs at life sciences companies. In an industry that has been significantly impacted by COVID-19 on many fronts, so has the approach to risk assessment and mitigation. In this Webinar, Guidehouse speakers will discuss evolving strategies to identify and assess known and novel risk factors as we rise to meet the challenges of today’s world. Additionally, this Webinar will examine best-in-class in compliance risk monitoring techniques fit for the virtual environment using accessible, impactful technologies to heighten insights surrounding commercial and medical interactions with customers, patients, and other third parties. At a time when field-based monitoring activities are increasingly constrained, gaining access to these insights through efficient use of advanced technology has never been more important for compliance executives.

Top Ten Benefits

Engage with industry thought leaders on risk assessment strategies in a rapidly changing environment.
Learn best practices in risk assessment techniques.
Hear how peer companies are re-evaluating existing business practices in the risk assessment framework.
Learn how the all-virtual working environment is impacting data collection and analysis processes.
Get pointers on executive and employee engagement during the risk assessment process in the current environment.
Learn how COVID-19 is impacting risk registers and risk scoring.
Hear how companies are evolving their risk monitoring techniques.
Examine recent case studies and lessons learned.
Learn how to adapt technology to improve the risk detection and evaluation process.
Discuss best practices for integrating risk assessment into a comprehensive risk assessment and mitigation program.

SPEAKERS

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Katherine C. Norris

MPA, DIRECTOR, LIFE SCIENCES - GOVERNANCE, RISK MANAGEMENT AND COMPLIANCE, GUIDEHOUSE

Katie Norris has 19 years of experience in corporate governance, risk and compliance focused predominantly in the life sciences and healthcare industries, including 12 years as an industry professional. Ms. Norris regularly supports counsel to assess the effectiveness of corporate compliance programs in privileged consulting matters coinciding with government investigations. She has supported clients in numerous high-profile matters, including the prosecution of individuals, led by the U.S. DOJ, HHS OIG, SEC, FDA, CMS, and EPA, among others. Ms. Norris also works directly with companies under enforcement decrees on a wide variety of compliance-related matters to ensure successful performance under CIA/DPA. She has developed and overseen all aspects of compliance and risk management programs at pharmaceutical and medical device companies, including: Board of Directors communications and certifications; CIA implementation; fair market value assessments; Risk Assessment and Mitigation Programs; auditing and monitoring; interactions and engagements with health care professionals; strategic marketing and sales initiatives involving Class II pharmaceuticals and Class III medical devices; transparency reporting; class-wide REMS compliance for controlled substances; and clinical, R&D and post-market surveillance. She has also managed global FCPA/ABAC programs as well as a complex OFAC/ITAR/EAR compliance program for the manufacture, sale and distribution of chemical weapons antidotes sold exclusively to US and foreign militaries. She has performed numerous complex compliance investigations and led restructuring initiatives on topics ranging from third party funding to free drug and patient assistance programs and interactions with specialty pharmacies. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/09/Casey-J-Horton-300x247.png' attachment='25138' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Casey J. Horton

CFE, DIRECTOR, LIFE SCIENCES – GOVERNANCE, RISK MANAGEMENT & COMPLIANCE, GUIDEHOUSE

Casey J. Horton has over twenty years of experience leading numerous risk, compliance, and operational improvement projects, both in the US and across the globe. Casey brings Guidehouse clients a unique perspective and understanding of the regulatory and operational challenges facing life sciences companies. His practice focuses on performing compliance assessments and investigations, reviewing and optimizing organizational processes, and implementing effective and sustainable compliance solutions. A practice leader in Guidehouse’s Global Life Sciences Governance, Risk Management, and Compliance practice, Casey brings deep experience and knowledge of compliance program development, Corporate Integrity Agreements (“CIAs”), compliance and enterprise risk assessment execution, global monitoring and investigations initiatives, anti-bribery / anti-corruption issues, third-party due diligence review programs, patient services, and assistance program reviews and financial and economic damage calculations. Casey’s expertise includes developing and implementing global compliance programs, assisting the client in the development and optimization of organizational processes, supporting clients through settlement and implementation of CIAs, preparing for Independent Review Organization (“IRO”) reviews, and providing IRO services. Prior to joining Guidehouse, Casey worked internally within a Top 10 pharmaceutical manufacturer’s Office of Ethics and Compliance (“OEC”) during CIA implementation and execution. Casey also has experience in developing, implementing, executing, and evaluating healthcare compliance auditing and monitoring programs, developing and operationalizing policies and procedures, and developing metrics, key performance indicators (“KPI”), and reports for regular review by Senior Management and Boards of Directors. [/av_textblock] [/av_three_fourth][/av_section]

September 10, 2020/by Chiara Travisano

Patient Assistance Programs: Recent Enforcement, Current Litigation and Evolving Practices

SPEAKERS

Jesse A. Witten

Applying CSA Concept To Data Integrity – Updates on ISPE GAMP GPG DI & CSA Appendix

SPEAKERS

Raechelle Raimondo

Senthil Gurumoorthi

Ken Shitamoto

Fraud and Corruption Risks Tied to Domestic and Foreign HCP Interactions - Enforcement Trends and Key Risk Indicators

Top Ten Benefits

SPEAKERS

Winston Y. Chan

Michele Wiener

John Partridge

Reid F. Rector

ASSOCIATE ATTORNEY, GIBSON DUNN

Key Lessons You Need to Know from Enforcement Actions in the Life Sciences Industry in 2020 and the Outlook for 2021

Key Takeaways From this Session

SPEAKERS

Sarah K. diFrancesca

Craig Bleifer

Trouble Sleeping? What is Keeping In-House Counsel and Compliance Officers Up at Night

Top Ten Benefits

SPEAKERS

John E. Kelly

MANAGING PARTNER, BASS BERRY & SIMS

Data-Based Process Monitoring, Control and Improvement A Systematic Approach

Top Ten Benefits – What the Attendees will Learn

SPEAKERS

Ronald D. Snee

Data Integrity Remediation: It is NOT a One-Time Activity!

Top 6 Reasons to Attend

SPEAKERS

Abhinaya Rajasekaran

Loganathan Kumarasamy

A Moving Target: Adapting Risk Assessment and Mitigation Strategies to the COVID-19 Era

Top Ten Benefits

SPEAKERS

Katherine C. Norris

Casey J. Horton

Patient Assistance Programs:
Recent Enforcement, Current
Litigation and Evolving Practices

Applying CSA Concept To
Data Integrity – Updates on ISPE GAMP GPG
DI & CSA Appendix

Fraud and Corruption Risks Tied to
Domestic and Foreign HCP Interactions -
Enforcement Trends and Key Risk Indicators

Key Lessons You Need to Know from
Enforcement Actions in the Life Sciences
Industry in 2020 and the Outlook for 2021

Trouble Sleeping?
What is Keeping In-House Counsel and
Compliance Officers Up at Night

Data-Based Process Monitoring,
Control and Improvement
A Systematic Approach

Data Integrity Remediation:
It is NOT a One-Time Activity!

A Moving Target:
Adapting Risk Assessment and
Mitigation Strategies to the COVID-19 Era