Off-Label Use in Europe
24.07.2017 17:50
Special issues in Europe: National rules regarding authorisation and reimbursement of off-label use
Termindetails
Wann
22.11.2017
von 09:00 bis 17:00
von 09:00 bis 17:00
Wo
Düsseldorf
Name
Kontakttelefon
+49 6221 500-696
Teilnehmer
This seminar will be of benefit to all those working in the pharmaceutical ndustry
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.
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.
This seminar addresses the different legal situations and the handling of off-label use in Europe. National course of action and the consequences for EU harmonisation will be particularly discussed.
Our experts will provide detailed information on the following areas of conflict: medical affairs, sales, pharmacovigilance, legal, insurance and clinical.
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 understand the regulations for health insurance companies regarding off-label use promotion and reimbursement.
Our experts will provide detailed information on the following areas of conflict: medical affairs, sales, pharmacovigilance, legal, insurance and clinical.
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 understand the regulations for health insurance companies regarding off-label use promotion and reimbursement.
Themen der Veranstaltung:
- 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 and healthcare cost controls: EU principles and national examples
- Advertising vs. information - what is possible?
- Event of damage: consequences and course of action
- Off-label use and healthcare cost controls: EU principles and national examples
