CRED Getting the CMC Dossier Right

CRED Getting the CMC Dossier Right
This course workshop led by agency and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information in Module 3 of the regulatory dossier. This course will focus on synthetic molecules.

When: 4-5 September 2024
Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom
Start time day 1: 09:00 BST
End time day 2: 16:45 BST

Course overview

You will be provided with an update on the latest scientific requirements, an insight into the data requirements and common regulatory issues for substance and drug product. You will hear from a Regulatory Authority on 'how to get it right the first time', including potential pitfall areas; what makes a good quality summary and practical issues in the presentation of Module 3 of Marketing Authorisation Applications. You will also have the opportunity to take part in case studies to illustrate lessons learned. 

Benefits to delegates

  • Gain a comprehensive overview of the requirements for Module 3 of the regulatory dossier
  • Participate in case studies and interactive lessons - learn by doing
  • Have the opportunity to interact with speakers from Regulatory Agencies in a neutral environment
  • Learn from experts in the field
  • Build a network to support the rest of your career
  • Learn the common pitfalls to avoid 
  • Take a course developed by professionals for professionals with a proven track record.
CPD: This course provides 14.5 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Please see last year's programme here.


Presenters for this course include:

  • Chris Carr, Bio Products Laboratory Limited
  • Christian Monnerjahn, Eckert & Ziegler Radiopharma GmbH
  • Bassel Odeh, MHRA
  • Olivier Dirat, Pfizer 
  • Vimal Patel, Regulatory CMC Expert
  • Paul Marshall, Jazz Pharmaceuticals
  • Alejandro Monton Silva, Medicines Evaluation Board (MEB)
  • Nynke Brouwer, Medicines Evaluation Board (MEB)
  • Sargon Daniel, Aimmune Therapeutics 
  • Bethany Jackson, AstraZeneca -UK 


Suitable for

  • Less experienced regulatory professionals who require comprehensive information on CMC (Synthetic molecules)
  • Experienced professionals who are newcomers to CMC (Synthetic molecules)
  • Anyone who wishes to update their knowledge in CMC (Synthetic molecules)


Simply log in or create an account and register below.

Type Member Non-member 
Standard    £955+VAT  £1,130+VAT
Add membership to your booking to access the members' discount. 

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at for a discount code before making your booking.

Those working for regulatory agencies, government agencies or academic institutions 
Those working for charities, patient groups or in full-time education
 £477.50+VAT  £565+VAT

*VAT, if applicable, is charged at the rate of 20%

Terms and conditions

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.

04/09/2024 - 05/09/2024
TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London, United Kingdom E14 9GE UNITED KINGDOM
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