CRED+ Optimising Interactions With Regulators

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

When:  1 December 2020
Where: Online



TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please meetings@topra.org.

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

Gabiele Disselhoff Gabriele Disselhoff 
Managing Director
Creative Regulatory & Quality Solutions (CRQS)

 

Otmar Pfaff Otmar Pfaff 
Vice President, Regulatory Affairs
CureVac AG

 

Elena Razzano
Senior Pharmaceutical Assessor
MHRA

 

Suitable for

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

Pricing

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 20%

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions

Related courses

Next steps

When
01/12/2020
Where
ONLINE
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or 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