LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE

Track:
Legal/Transparency-Risk Assessment

Day & Time:
March 6, 2:00PM - 3:30PM

Session Number:
0307

Room Number:
Emerald Room

Type:
Session

Title:
LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE

Chair(s):
John A. Lisman, LLM,MPharm
Lawyer
Lisman Legal Life Sciences B.V., Netherlands

Description:
This session will look into positive and negative aspects of off-label use of medicines and explain reasons for the existence of the practice. Both the EU and the US situation will be scrutinized.

Presentation(s) & Speaker(s):
Off-Label Use from the Regulatory Perspective: A necessary evil or a blessing in disguise?
Yechiel Hekster
Professor of Clinical Pharmacy
Medicines Evaluation Board, Netherlands

Off-Label Use from the Industry Perspective: Walking a tight rope?
Hector Roethlisberger
Corporate Counsel
Takeda Pharmaceuticals, Switzerland

Legal and Practical Aspects of Off-Label Use.
John A. Lisman, LLM,MPharm
Lawyer
Lisman Legal Life Sciences B.V., Netherlands