Program Schedule

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

PROGRAM SCHEDULED for Fall 2015 | 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/Compliance Challenge
Amy Cattafi, Seton Hall Law School

9:30 - 10:10

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

10:10 - 11:10

Federal Health Care Reimbursement Programs for Drug & Device Manufacturers
Kim Tyrrell-Knott, Epstein Becker & Green P.C.

11:10 - 11:30

Break

11:30 - 12:30

Navigating State, Federal & International Transparency Disclosure Requirements
Mike Bell, R-Squared
Carolyn Bruguera, R-Squared

12:30 - 1:30

Lunch

1:30 - 2:20

Government Pricing Programs: Key Issues for Compliance Professionals
Kathleen Peterson, Cooley LLP

2:20 - 3:10

Adhering to Industry Codes of Conduct
Daniel Cody, Reed Smith

3:10 - 3:30

Break

3:30 - 4:15

Building a Successful Compliance Program from the Ground Up
Wendy Goldstein, Cooley LLP

4:15 - 5:30

Interactive Session: Compliance Officers Panel Discussion
Susan Clarke, Johnson & Johnson
Fabiana Lacerca-Allen, formerly of Elan
Jacquie Haggarty, Genomic Health
Moderator: Professor Kathleen Boozang, 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 - 11:00

The False Claims Act & its Applicability to the Life Sciences Industry
Speaker Invited

11:00 - 11:20

Break

11:20 - 12:10

Global Corruption Risks: The Foreign Corrupt Practices Act & Beyond
Fabiana Lacerca-Allen, formerly of Elan

12:10 - 1:10

Lunch

1:10 - 2:00

Optimizing the Risk Assessment Process
Susan Clarke, Johnson & Johnson

2:00 - 2:50

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

2:50 - 3:10

Break

3:10 - 4:00

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

4:00 - 5:30

Government Panel Discussion: Healthcare Fraud Enforcement
Sara Winslow, AUSA, N. Dist. of California 
Kirstin Ault, AUSA, N. Dist. of California
Charles Gunther, FBI
Josh Hill, Sidley Austin
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
Anup Kharode, PwC

11:30 - 12:30

Drug & Device Advertising & Promotion, Scientific & Educational Activities
Speaker Invited

12:30 - 1:30

Lunch

1:30 - 2:10

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

2:10 - 3:00

Data Protection Overview for Life Sciences Companies
Kenia Rincon, PwC
Peter Claude, PwC

3:00 - 3:20

Break

3:20 - 4:00
Issues to Consider When Preparing for an IPO or Acquisition

Carolyn Bruguera, R-Squared

4:00 - 5:30

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

5:30 - 5:45

Concluding Remarks





Partners

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