Life Sciences Compliance Training - Program Schedule

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

PROGRAM SCHEDULE for March 27-29, 2017 | 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 /Continental breakfast sponsored by IMS Health

9:00 - 9:30

Program Introduction & Overview; Introductions/Ice-Breaker
Professor Timothy Glynn, Seton Hall Law School
Amy Matey, 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
Katherine Buckley, PwC (Philadelphia)

11:30 - 12:30

Navigating State, Federal & International Transparency Disclosure Requirements
Carolyn Bruguera, IMS Health (San Francisco)

12:30 - 1:30

Lunch

1:30-1:45

Interactive Class Hypo

1:45 - 2:35

Government Pricing Programs: Key Issues for Compliance Professionals
Wendy Goldstein, 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/Lessons Learned from CIAs
Sarah diFrancesca, Cooley LLP (New York)

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, formerly of 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, Gilead Sciences, Inc. (Foster City, CA)

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)

12:10-12:40

Leadership, Strategic Risk, and Compliance
Fabiana Lacerca-Allen, Ethiprax (Hayward, CA)
Col. Randy Bagwell, U.S. Army

12:40 - 1:40

Lunch sponsored by BioMarin

1:40-2:30

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

2:30 - 3:20

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

3:20 - 3:35

Break

3:35 - 4:25

What Events Should Trigger an Internal Investigation
Jack DiCanio, Skadden, Arps, Slate, Meagher & Flom (Palo Alto, CA)

4:25 - 5:45

Government Panel Discussion: Healthcare Fraud Enforcement
Kirstin Ault, AUSA, N. Dist. of California (San Francisco)
Josh Hill, Sidley Austin (San Francisco)
Brian Weber, FBI (San Francisco)
Sara Winslow, AUSA, N. Dist. of California (San Francisco)
Moderator: Professor Timothy Glynn, Seton Hall Law School

5:30 - 7:00

Welcome Reception for Faculty & Attendees sponsored by Cooley LLP

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 & Burling (San Francisco)

10:20 - 10:40

Break

10:40 - 11:30

Clinical Research Activities & Related Compliance Risks
Torrey Cope, Sidley Austin (Washington, D.C.)

11:30 - 12:30

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

12:30 - 1:30

Lunch sponsored by Cadwalader, Wickersham & Taft LLP

1:30-1:45

Interactive Class 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 (Washington, D.C.)

2:25 - 3:15

Data Protection Overview for Life Sciences Companies
Peter Claude, PwC (San Francisco)
Kenia Rincon, PwC (Fort Lauderdale)

3:15 - 3:30

Break

3:30 - 4:10

Issues to Consider When Preparing for an IPO or Acquisition
Carolyn Bruguera, IMS Health (San Francisco)

4:10 - 5:30

Compliance Case Study Workshop: Pulling it All Together & Creating Your Compliance Team
Naoko Fujii, Clementine Consulting LLC (Palo Alto, CA)

5:30 - 5:45

Concluding Remarks & Award of Certificates

 

 

 



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