When: 22 June 2021
Where: Online
Course overview
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.
*Optional
Benefits to delegates
- 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
CPD: This course provides 8 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the programme here.
Presenters include
Otmar Pfaff - Pharmacist (former SVP Curevac, Regulatory Affairs BI, and SD at Merck)
Elena Razzano - Senior Pharmaceutical Assessor, MHRA
Elmar Schmitt - Executive Director, Global Regulatory Affairs – TA Oncology, Merck
Gabriele Disselhoff - Managing Director, Creative Regulatory & Quality Solutions (CRQS)
Suitable for
Experienced professionals and team leaders who are involved in interactions with Regulators.
Pricing
Standard
- Member: £550+VAT*
- Non-member: £675+VAT*
Discounted places
A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.
- Those working for regulatory agencies, government agencies or academic institutions:
- Members: £412.50+VAT
- Non-members: £506.25+VAT
- Those working for charities, patient groups or in full-time education:
- Members: £275+VAT
- Non-members: £337.50+VAT
*VAT, if applicable, is charged at the rate of 20%.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions
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