Course description
Optimising Interactions With Pharmaceutical and Medical Device Regulators
Workshop leaders with industry and agency backgrounds will explain how to manage these critical interactions. This practical workshop also provides you with the opportunity to bring your own cases* or questions, and to participate in speakers' case studies to help you prepare for upcoming advice from EU and US health authorities.
If you’re interacting with regulators for the first time or leading on seeking scientific advice for your company this is the workshop for you.
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Upcoming start dates
Suitability - Who should attend?
Suitable for
Experienced professionals and team leaders who are involved in interactions with Regulators.
Outcome / Qualification etc.
Benefits to participants
- Experience the best way to organise and prepare your health authority interaction
- Feel confident in how to present your case, make your point and use your time at health authorities efficiently
- Get advice on how to handle your own cases
- Understand the necessity of a fallback strategy
- Know how to manage your delegation for achieving the best output
- Understand the view of the agency.
- Build a network to support the rest of your career
- Meet and learn from ex-regulators
- Learn by doing - participate in case studies and interactive sessions
- Take a course designed by professionals for professionals with a proven track record
Training Course Content
- Introduction
- Introduction participants and faculty
- Active discussion on possibilities for interactions with your Regulators
- Introduce participants’ own examples /cases
Expenses
The full tuition price for Members is 550 GBP. The price for Non-members is 675 GBP