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Healthcare Compliance Training - Program Schedule

U.S. Healthcare Compliance Certificate Program

[email protected] | 973-642-8871 or 973-761-9000 ext. 8871

PROGRAM SCHEDULED for June 10-13, 2019 | Newark, New Jersey

This schedule is subject to change and will be provided on the first day of the Program.

DAY 1
8:30 - 9:00	Program Opens; Continental Breakfast
9:00 - 9:30	Program Introduction & Overview/Compliance Challenge Amy Matey, Seton Hall Law School
9:30 - 10:20	The Relationship Between Ethics and Legal Compliance Professor Timothy P. Glynn, Senior Associate Dean, Seton Hall Law School
10:20 - 10:40	Break
10:40 - 11:50	Navigating State, Federal & International Transparency Disclosure Requirements John Oroho, Porzio Life Sciences, LLC Keren Bisnauth, Porzio Life Sciences, LLC
11:50 - 12:50	Networking Lunch
12:50 - 2:20	Topics in Privacy and Data Protection: Pharmaceutical and Biotech Privacy Considerations Libbie Canter, Covington & Burling LLP
2:20 - 2:40	Break
2:40 - 4:00	An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers Lynn Shapiro Snyder, Epstein Becker and Green, P.C.
4:00 - 4:15	Break
4:15 - 5:15	Government Pricing Regulation: Key Issues for Compliance Professionals Joseph Metro, Reed Smith LLP
DAY 2
8:30 - 9:00	Continental Breakfast sponsored by Drinker Biddle & Reath LLP
9:00 - 10:15	Choose a Track: Track 1: FDA Regulation of Drug Development & Approval Michael Stern, Covington & Burling LLP Track 2: FDA Regulation of Medical Devices Christopher Hanson, Covington & Burling LLP
10:15 - 10:35	Break
10:35 - 12:00	Data Analytics Michael Driscoll, Johnson & Johnson Jacob Elberg, Seton Hall Law School Anna Templo, Johnson & Johnson
12:00 - 1:00	Networking Lunch sponsored by Paul Hastings LLP
1:00 - 2:00	A Journey to the Dark Side of International Business: Lessons Learned from the Front Lines Richard Bistrong, CEO, Front-Line Anti-Bribery LLC; former FCPA Violator & FBI/UK Cooperator
2:00 - 3:15	The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement) Gary Giampetruzzi, Paul Hastings LLP Co-presenter TBA
3:15 - 4:15	The Perils of Dealing with Whistleblowers Under the False Claims Act Lynne Anne Anderson, Drinker Biddle & Reath LLP Jesse Witten, Drinker Biddle & Reath LLP
4:15 - 4:30	Break
4:30 - 5:45	The Federal Anti-Kickback Statute Bruce Levy, Gibbons P.C.
5:45 - 7:00	Cocktail Reception sponsored by Gibbons P.C. (Atrium)
DAY 3
8:30 - 9:00	Continental Breakfast
9:00 - 10:15	Industry Interactions with Patients Panel Discussion Patrik Florencio, Amicus Therapeutics Jayne Gershkowitz, Amicus Therapeutics Ellen Rosenberg, Amicus Therapeutics Moderator: Stefanie Doebler, Covington & Burling LLP
10:15 - 10:35	Break
10:35 - 12:20	Prescription Drug & Medical Device Advertising/Scientific & Educational Activities Elizabeth Kim, Loeb & Loeb LLP
12:20 - 1:20	Networking Lunch
1:20 - 2:10	Compliance Lessons Learned from Corporate Integrity Agreements Seth Lundy, King & Spalding
2:10 - 3:25	Compliance Case Study: Break-Out Session & Workshop
3:25 - 3:45	Break
3:45 - 5:00	Compliance Officers Panel Discussion Charlene Davis, Sun Pharmaceutical Industries, Inc. Jill Fallows-Macaluso, Novo Nordisk Holly Kramen, PolarityTE Joseph Zimmerman, Ferring Pharmaceuticals Inc. Moderator: Regina Gore Cavaliere, KPMG LLP
DAY 4
8:30 - 9:00	Continental Breakfast
9:00 - 9:50	Recent Developments in Federal Health Care Fraud Enforcement & The Value of Compliance and Cooperation Rachael Honig, U.S. Attorney’s Office, District of New Jersey
9:50 - 10:40	Before I Was a Compliance Officer - Notes of a Recovering Prosecutor Jim Sheehan, Office of the New York Attorney General
10:40 - 11:00	Break
11:00 - 12:15	Panel Discussion: Being the Focus of a Government Investigation Mike Doyle, Federal Bureau of Investigation Rachael Honig, U.S. Attorney’s Office, District of New Jersey Jenny Kramer, Alston & Bird Scott McBride, Lowenstein Sandler P.C. Jim Sheehan, New York Attorney General’s Office Moderator: Jacob Elberg, Seton Hall Law School
12:15 - 1:15	Networking Lunch sponsored by Lowenstein Sandler, LLP
1:15 - 2:20	Health Care Fraud Sentencing, Penalties, Damages & Other Considerations Scott McBride, Lowenstein Sandler, LLP Jenny Kramer, Alston & Bird Joseph Mack, Bayer U.S.
2:20 - 2:40	Break
2:40 - 3:45	AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals Katie Pawlitz, Reed Smith LLP
3:45 - 4:00	Concluding Remarks and Award of Certificates