Off-Label Use in Europe
Termindetails
Wann
von 09:00 bis 17:30
Wo
Name
Kontakttelefon
Teilnehmer
working in the pharmaceutical industry
who need an in-depth understanding of
the current off-label use regulation in
Europe and the opportunities and risks of
off-label use. Those working in:
-Medical Affairs
-Pharmacovigilance
-Marketing/Sales
-Law
will especially profit from the seminar.
Aims and objectives:
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.
Our experts will provide detailed information on the following areas of conflict:medical affairs, sales,pharmacovigilance, legal and insurance.
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 minimize the risk. Moreover you will understand the regulations for health insurance companies regarding off-label use promotion and reimbursement.
Topics:
- 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?
