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: 2-3 September 2025
Where: Online
Start time day 1: 08:45 GMT
End time day 2: 16:30 GMT


Also available as a face-to-face course, please click here for the face-to-face registration option.

 

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. 

I attended in-person training last year. I wondered how virtual training would go. I am very impressed with how the complexities of this course were handled. I feel like I learned a lot as well as being able to consolidate my experience to date.”  – 2020 delegate

Benefits to delegates

  • Gain a comprehensive overview of the requirements for Module 3 of the regulatory dossier
  • Learn the common pitfalls to avoid 
  • Have the opportunity to interact with speakers from Regulatory Agencies in a neutral environment
  • Learn from experts in the field
  • Participate in case studies and interactive lessons - learn by doing
  • Build a network to support the rest of your career
  • Take a course developed by professionals for professionals with a proven track 
     
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.

Programme

Download a draft copy of the course programme here.

Presenters

Suitable for

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

Pricing  

Standard

  • Member: £1,050 +VAT*
  • Non-member: £1,250 +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: £787.50 +VAT
    • Non-members:  £937.50 +VAT
  • Those working for charities, patient groups or in full-time education:
    • Members: £525 +VAT
    • Non-members: £625 +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.
When
02/09/2025 - 03/09/2025
Where
Online
Online registration not available.
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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

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