Life Sciences Compliance Training - Program Schedule

U.S. Compliance Certification Program for Smaller Life Sciences Companies

PROGRAM SCHEDULED for March 21-23, 2016 | San Francisco, California


This schedule is subject to revisions and will be provided on the first day of the Program.
DAY 1

8:30 - 9:00

Program Registration / Sign-In

9:00 - 9:30

Program Introduction & Overview; Introductions/Ice-Breaker
Amy Cattafi, Seton Hall Law School
Professor Timothy Glynn, Seton Hall Law School

9:30 - 10:10

Business Ethics and Legal Compliance
Professor Timothy Glynn, Seton Hall Law School

10:10 - 10:30

Break

10:30-11:30

Federal Health Care Reimbursement Programs for Drug & Device Manufacturers
Speaker TBD

11:30 - 12:30

Navigating State, Federal & International Transparency Disclosure Requirements
Mike Bell, R-Squared (Princeton, NJ)
Carolyn Bruguera, R-Squared (San Francisco)

12:30 - 1:30

Lunch

1:30-1:45

Re-cap Hypo

1:45 - 2:35

Government Pricing Programs: Key Issues for Compliance Professionals
Kathleen Peterson, Cooley LLP (Washington, D.C.)

2:35 - 3:25

Adhering to Industry Codes of Conduct
Daniel Cody, Reed Smith (San Francisco)

3:25 - 3:40

Break

3:40 - 4:25

Regulatory Developments Informing Compliance Programs
Wendy Goldstein, Cooley LLP

4:25 - 5:30

Interactive Session: Compliance Officers Panel Discussion
Susan Clarke, Johnson & Johnson (Menlo Park, CA)
Jacquie Haggarty, 23andMe, Inc. (Mountain View, CA)
Fabiana Lacerca-Allen, Ethiprax (Hayward, CA)
Sumita Ray, Pharmacyclics (Sunnyvale, CA)
Moderator: Professor Timothy Glynn, Seton Hall Law School

DAY 2

8:30 - 9:00

Sign-In

9:00 - 10:00

The Federal Anti-Kickback Statute
Hae-Won Min Liao, Sidley Austin

10:00 - 10:20

Break

10:20 - 11:20

The False Claims Act
Josh Hill, Sidley Austin (San Francisco)

11:20-12:10

Global Corruption Risks: the Foreign Corrupt Practices Act and Beyond
Fabiana Lacerca-Allen, Ethiprax (Hayward, CA)

12:10 - 1:10

Lunch

1:10 - 1:25

Re-cap Hypo

1:25-2:15

Optimizing the Risk Assessment Process
Susan Clarke, Johnson & Johnson (Menlo Park, CA)

2:15 - 3:05

State Laws that Could Delay Product Launch or Distribution
John Oroho, Porzio, Bromberg & Newman (Morristown, NJ)

3:05 - 3:20

Break

3:20 - 4:10

What Events Should Trigger an Internal Investigation
Jack DiCanio, Skadden, Arps, Slate, Meagher & Flom

4:10 - 5:30

Government Panel Discussion: Healthcare Fraud Enforcement
Sara Winslow, AUSA, N. Dist. of California (San Francisco)
Charles Gunther, FBI (San Francisco)
Josh Hill, Sidley Austin
Hartley West, AUSA, N. Dist. Of Calif. (San Francisco)
Moderator: Professor Timothy Glynn, Seton Hall Law School

5:30 - 7:00

Welcome Reception for Faculty & Attendees

DAY 3

8:30 - 9:00

Sign-In

9:00 - 10:20

FDA Regulation of the New Drug & New Device Development & Approval Process
Scott Cunningham, Covington & Burlington

10:20 - 10:40

Break

10:40 - 11:30

Clinical Research Activities & Related Compliance Risks
Speaker TBD

11:30 - 12:30

Drug & Device Advertising & Promotion, Scientific & Educational Activities
Elaine Tseng, King & Spalding (San Francisco)

12:30 - 1:30

Lunch

1:30-1:45

Re-cap Hypo

1:45 - 2:25

Cross-Border & International Regulatory Issues - Managing Evolving Compliance Priorities During the Lifecycle of your Company
Bret Campbell, Cadwalader, Wickersham & Taft

2:25 - 3:15

Data Protection Overview for Life Sciences Companies
Peter Claude, PwC

3:15 - 3:30

Break

3:30 - 4:10

Issues to Consider When Preparing for an IPO or Acquisition
Carolyn Bruguera, R-Squared

4:10 - 5:30

Compliance Case Study Workshop: Pulling it All Together & Creating Your Compliance Team
Naoko Fujii, Xenoport

5:30 - 5:45

Concluding Remarks & Award of Certificates





Partners

Colorado Bio Science Association   BayBio  Bio Utah  ADVAMED   WBBA: Washington Biotechnology & Biomedical Association