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PRODUCT LIABILITY, OFF-LABEL USE AND PATIENT INFORMATION LEAFLETS

Track:
The Role of Transparency and Ethics: Legal aspects

Day & Time:
March 27, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
1307

Room Number:
F2

Type:
Session

Title:
PRODUCT LIABILITY, OFF-LABEL USE AND PATIENT INFORMATION LEAFLETS

Chair(s):
Karina Erika Hellbert, DrSc, LLM
Partner
Fiebinger Polak Leon & Partner, Austria

Description:
The patient has a right to be transparently informed about the risks associated with taking medicinal products. The session deals with liability issues if such information is not provided, for instance because the product is not provided for such use, is wrongly given or is simply not known at the time when the actual damage occurred.

Presentation(s) & Speaker(s):
Product Liability and Off-Label Use
Bernd Unterkofler
Legal advicer
Austrian Medicines and Medical Devices Agency (AGES), Austria

Product Liability and Harmonised Patient Information Leaflet for MRP Products
Ina Brock
Hogan Lovells, Germany

Are There Circumstances Possible Under Which a Generic Company Could be Held for Shortcomings of an Innovator and Vice-Versa, for Instance Due to PIL?
Christophe Ronse
ALTIUS, Belgium