Optimising Interactions With Regulators

Optimising Interactions With Regulators
A practical workshop covering interactions with EU and US health authorities and how to manage them effectively.

When
: 14 March 2019
Where: Amsterdam, The Netherlands 
Time: 09.00 - 17.00




Course overview

Workshop leaders with industry and agency backgrounds will explain how to manage these critical interactions. The practical workshop also provides 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.

*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.
  • 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.
  • 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 7.5 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Programme

The latest course programme can be downloaded here.

Presenters


 


 
 Gabriele Disselhoff
Creative Regulatory & 
Quality Solutions (CRQS)
 Truus Janse-de Hoog
Medicines Evaluation Board - Netherlands
 Otmar Pfaff
CureVac AG 
 












Suitable for

Experienced professionals and team leaders who are involved in interactions with Regulators.


Pricing  

Book now at 2018 registration fees! 

Type Member Non-member 
Standard    £550+VAT  £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 
 £412.50+VAT
 £506.25+VAT
Those working for charities, patient groups or in full-time education
 £275+VAT  £337.50+VAT

*VAT, if applicable, is charged at the rate of 21%

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Next steps

When
14/03/2019
Where
Hotel Novotel Amsterdam Schiphol Airport Taurusavenue 12 2132 LS HOOFDDORP NETHERLANDS
Your VAT country
Your Vat number
NOTE
If your company VAT number does not appear here or you would like to be invoiced using a different VAT number please email finance@topra.org

Register now

Our policy on photography and video

On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

However, if for any reason you do not wish TOPRA to use your image or voice please let us know

Recording and photography by delegates is not permitted.