Health Authority (HA) meetings with the major HAs (ICH region) are an essential part of drug development. Each pharmaceutical company will sooner or later be faced with such meetings. This important course covers HA meetings in the EU and in the US.
This course is a hands-on course full of practical work. It is necessary that you bring your laptop with you.
- Different kinds of HA meetings in the EU and in the US
- How to prepare for HA meetings
- The questions to ask
- How to get the most out of HA meetings
- How to negotiate
Who Should Attend
Anyone who is part of a delegation for an HA meeting. Normally, Regulatory Affairs departments lead the delegation, but depending on the topics to be discussed, representatives from the following disciplines may be required to join:
- Clinical Research
- Non-clinical disciplines
- Drug Safety
- Chemical-pharmaceutical disciplines
- Medical Affairs
- Project Management
At the conclusion of this course, participants should be able to:
- Feel confident about managing HA meetings
- Know when you should request a HA meeting
- Be prepared when you are invited for a meeting
- Be sure which questions you should and should not ask
- Learn how to interact with HA counterparts
- Understand how to best communicate the outcome of the HA interaction to your management and how to drive implementation
- Participants will complete a knowledge check at the end of the course and will be provided withfeedback to ensure learning objectives are attained.
Hotel & Travel
DIA has blocked a limited number of rooms at the following hotel:
Hotel Novotel Paris Charenton
3-5 place des Marseillais
94227 Charenton Le Pont
at the rates of EUR 150.00 per room inclusive of breakfast and exclusive of VAT.
To make your reservation please use the hotel booking form.
Important: The room rate is available until 30 August 2014 or until the group block is sold-out, whichever comes first.
In case of cancellation: The room can be cancelled 43 hours prior arrival, after that the credit card will be charged for the 1st night.
The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station, the vibrant Bastille district & Bercy. The liberté metro station (line 8) opposite the hotel gives direct access to Paris's main attractions like Place de la Concorde, Eiffel Tower, Opéra, etc.