Agenda Links: Preconferences/Day 1 | Day 2
AGENDA: DAY 3
FRIDAY, NOVEMBER 8, 2019
INDUSTRY ONLY BEST PRACTICES THINK TANK
Hosted by Pharmaceutical Compliance Forum
(Industry-only session for pharmaceutical company compliance professionals and in-house counsel only)
8:00 am
Welcome & Anti-Trust Admonition
Sujata T. Dayal, JD
Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Co-chair)
Vice President, Health Care Compliance and Privacy, Pharmaceuticals Group, Johnson & Johnson, Titusville, NJ (PCF Co-chair)
Sujata Dayal is the Vice President Health Care Compliance & Privacy, Pharmaceuticals for Johnson & Johnson. She is responsible for overseeing health care compliance organization and program for the global pharmaceutical group. Previously, she was the Global Chief Compliance Officer and Corporate Vice President for Biomet, Inc. There she was responsible for development, implementation and oversight of global compliance program with a focus on healthcare compliance and anti-corruption. She was also, Partner with Karmact, LLC, and Ethics and Compliance Officer for Abbott Laboratories. Ms. Dayal is experienced in setting up global compliance programs, including conducting risk-assessments, policy and procedure writing, training, monitoring and promotional review. Her areas of expertise include health care compliance, FCPA and regulatory law and her specialties include: Compliance Programs, Anti-corruption, Contracts, Regulatory Law, Promotional Review, Fraud and Abuse, Privacy
8:10 am
Thoughts from a Former Government Prosecutor on Data Analytics, Monitoring and Measuring Compliance Effectiveness
Jacob T. Elberg, JD
Associate Professor of Law, Seton Hall Law School, U.S. Attorney’s Office, District of New Jersey; Former Chief, Health Care & Government Fraud Unit and Assistant U.S. Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ
Associate Professor of Law, Seton Hall Law School, U.S. Attorney’s Office, District of New Jersey; Former Chief, Health Care & Government Fraud Unit and Assistant U.S. Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice, Newark, NJ
Jacob Elberg is an Associate Professor at Seton Hall University Law School where he teaches in the areas of Health Care Fraud & Abuse, Health Law, Data Analytics, and Evidence. Professor Elberg also serves as a faculty advisor for Seton Hall’s Health Care Compliance Programs around the world. Prior to joining Seton Hall’s faculty full-time, Professor Elberg was Chief of the Health Care & Government Fraud Unit at the U.S. Attorney’s Office for the District of New Jersey, where he supervised all criminal and civil investigations involving health care fraud.
9:10 am
Lessons Learned from the Recent Co-Pay Assistance Settlements and which may Apply to Patient Interactions/and Other Assistance Programs
Stefanie A. Doebler, JD
Of Counsel, Covington & Burling LLP, Washington, DC
Of Counsel, Covington & Burling LLP, Washington, DC
Stefanie Doebler is of counsel in Covington & Burling’s health care and food and drug practice groups.? Her practice focuses on health care compliance matters for pharmaceutical and medical device clients.? She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
Sarah A. Franklin, JD
Partner, and Vice-chair, Life Sciences Litigation and Investigations Practice Group, Covington & Burling LLP; Former Attorney, Bureau of Consumer Protection, Division of Marketing Practices, Federal Trade Commission, Washington, DC
Partner, and Vice-chair, Life Sciences Litigation and Investigations Practice Group, Covington & Burling LLP; Former Attorney, Bureau of Consumer Protection, Division of Marketing Practices, Federal Trade Commission, Washington, DC
Sarah Franklin is Partner and Vice-Chair of Covington’s Life Sciences Litigation and Investigations Practice group.
Ms. Franklin has defended numerous criminal and civil enforcement actions covering a broad range of health care compliance issues, including fraud and abuse, advertising and promotion, price reporting, and manufacturing. She also draws on her enforcement experience and industry knowledge to conduct internal investigations and regularly advises pharmaceutical, biotech, and medical device companies on mitigating risks and implementing compliance programs.
Ms. Franklin has defended numerous criminal and civil enforcement actions covering a broad range of health care compliance issues, including fraud and abuse, advertising and promotion, price reporting, and manufacturing. She also draws on her enforcement experience and industry knowledge to conduct internal investigations and regularly advises pharmaceutical, biotech, and medical device companies on mitigating risks and implementing compliance programs.
10:00 am
Break
10:15 am
Benchmarking Survey
10:30 am
Table Discussion Breakouts
- 40 minutes-Pre-identified topics for table discussions
- 20 minutes- Each table to share learnings (all)
11:30 am
Open Discussions
12:00 pm
Congress Adjournment
Agenda Links: Preconferences/Day 1 | Day 2