Off-Label Use in Europe

This seminar addresses the different legal
situations and the handling of off-label use
in Europe. The recent course of action in
Italy and France and the consequences
for the harmonisation will be particularly
discussed.
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Our experts will provide detailed information
on the following areas of conflict: medical
affairs, sales, pharmacovigilance, legal and
insurance.
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After the seminar you will be aware of the
difference between advertising, information
and pre-approval information for off-label
use, how to get knowledge of off-label use
and how to handle it. You will know who
is liable in cases of damage and how to
minimise the risk. Moreover you will under-
stand the regulations for health insurance
companies regarding off-label use promo-
tion and reimbursement.

Themen

- Areas of conflict: medical affairs - sales - pharmacovigilance - legal - insurance
- Advertising vs. information - what is possible?
- Event of damage: consequences and course of action
- Off-label use: tolerated, promoted and reimbursed by health insurance companies?