LEGAL COMPLIANCE FOR REGULATORY FUNCTIONS - LEARNINGS FROM RECENT ENFORCEMENT ACTIVITIES

Track:
Legal/Transparency-Risk Assessment

Day & Time:
March 5, 2:00PM - 3:30PM

Session Number:
0303

Room Number:
E102

Level:
Intermediate

Type:
Session

Title:
LEGAL COMPLIANCE FOR REGULATORY FUNCTIONS - LEARNINGS FROM RECENT ENFORCEMENT ACTIVITIES

Chair(s):
Samantha Regenthal, LLM
Attorney at Law
SFL Regulatory Affairs & Scientific Communication, Switzerland

Learning Objective(s):
1. Summary of recent enforcement activities and the consequences for Regulatory functions 2. Identification of potential pitfalls for Regulatory functions 3. Liability aspects overview 4. Compliance program trends and their impact on the Regulatory function.

Presentation(s) & Speaker(s):
The AstraZeneca Case and the Pharma Sector Investigation: Impact on Regulatory Strategies
Samantha Regenthal, LLM
Attorney at Law
SFL Regulatory Affairs & Scientific Communication, Switzerland

The GSK US Case: Relevance for European Regulatory Activities
Heidi Bürgi
Attorney at Law
F. Hoffmann-La Roche, Switzerland

Panel Discussion
Burkhard Straeter
Lawyer
Sträter Rechtsanwälte, Germany