When: Tuesday 13 March 2018
Where: TOPRA, 6th Floor, 3 Harbour Exchange Square, South Quay, London, E14 9GE
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This is a practical workshop providing you with the opportunity to bring your own cases and questions or participate in speakers' case studies to help you prepare for upcoming advice from EU and US health authorities. It is also an opportunity to have your own case studies reviewed by top regulatory experts.*
- 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
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Get advice on how to handle your own cases
- Understand the necessity of a fallback strategy
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Know how to manage your delegation for achieving the best output
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Understand the view of the agency.
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. Speakers will also discuss their own case studies.
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Programme
09.00 – 09.30 Introduction participants and faculty
09.30 – 10.30 Active discussion on possibilities for interactions with your Regulators
10.30 – 10.50 Introduce participants’ own examples /cases
10.50 – 11.10 Coffee break
11.10 – 12.30 Practical skill development
12.30 – 13.15 Lunch
13.15 – 14.45 Practical skill development / Participants’ cases
14.45 – 15.00 Coffee break
15.00 – 16.30 Practical skill development 3
16.30 – 17.00 Wrap up
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Meet the speakers
- Gabriele Disselhoff, Managing Director, Creative Regulatory & Quality Solutions (CRQS), Germany
- Truus Janse-de Hoog, Senior former Staff Member of the Medicines Evaluation Board in The Netherlands
- Otmar Pfaff, Vice President Regulatory Affairs, CureVac AG, Germany
Click here to find out more about our speakers
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Learning outcomes
- Experience the best way to organise and prepare your health authority interaction
- Feel confident on 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
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Who should attend
This workshop is suitable for experienced professionals and team leaders who are involved in interactions with Regulators.
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Why attend
This workshop will provide you with the opportunity to bring your own cases and questions to help you prepare for upcoming advice from EU and US health authorities.
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CPD
This course offers 6 CPD hours for successful completion. To learn about why CPD is important, visit our Lifelong Learning page.
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Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.
Course price (to register, please log in or create an account):
| Member: |
£550+VAT |
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Non-member: |
£675+VAT |
Discounted rates
A limited number of discounted discounted places are available to the groups mentioned below, please email us for the code before making your booking.
Those working for regulatory agencies or government agencies or academic institutions:
| Member: |
£412.50+VAT |
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Non-member: |
£506.25+VAT |
Those working for charities, patient groups or in full time education:
| Member: |
£275+VAT |
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Non-member: |
£337.50+VAT |
- All fees are shown in Pounds Sterling and do not include VAT
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).