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LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE
Session Chair(s)
John A. Lisman, LLM, MPharm
Advocaat/Attorney, Consultant, Trainer
Lisman Legal Life Sciences B.V., Netherlands
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.
Speaker(s)
Off-Label Use from the Regulatory Perspective: A necessary evil or a blessing in disguise?
Yechiel Hekster
Medicines Evaluation Board, Netherlands
Professor of Clinical Pharmacy
Off-Label Use from the Industry Perspective: Walking a tight rope?
Hector Roethlisberger
Takeda Pharmaceuticals International GmbH, Switzerland
Corporate Counsel
Legal and Practical Aspects of Off-Label Use.
John A. Lisman, LLM, MPharm
Lisman Legal Life Sciences B.V., Netherlands
Advocaat/Attorney, Consultant, Trainer
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