Getting the CMC Dossier Right

Getting the CMC Dossier Right
Build your expertise in Chemistry, Manufacturing and Controls (CMC) and gain a clearer understanding of what regulators expect from Module 3 submissions. Through practical guidance and expert insights, you'll learn how to avoid common pitfalls, enhance dossier quality and contribute more effectively to successful marketing authorisation applications.


This course is also available to attend online >



When: 28 - 29 September 2027
Where: TOPRA 3rd Floor, City Reach. 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: 09:00 | Day 2 end time: 16:45 GMT
CPD: 14.5 CPD hours upon successful completion

Who should attend

This course is ideal 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)

What you'll learn

By completing this course, you will be able to:

  • Navigate Module 3 CMC requirements with greater confidence.
  • Develop high-quality CMC submissions that align with regulatory expectations.
  • Identify and mitigate common risks that can lead to questions, delays or deficiencies.
  • Apply best practices from regulatory authorities and industry experts.
  • Enhance your effectiveness in CMC and regulatory affairs roles.


Course overview 

Preparing a high-quality CMC dossier is critical to achieving successful regulatory outcomes. This course provides practical guidance on the scientific and regulatory requirements for Module 3 of Marketing Authorisation Applications (MAAs) for synthetic molecules, helping you understand what regulators expect and how to avoid common deficiencies.

Through expert-led sessions and regulatory authority insights, you'll gain practical strategies to improve dossier quality, strengthen compliance and support more efficient marketing authorisation submissions.

Presenters

The expert presenters for this course will be announced soon


Pricing

TOPRA member: £1,250 + VAT
Non-member: £1,750 + VAT

Join TOPRA and enjoy the member rate on every training course you book. Become a member > 

Members working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets and MSEs can access further discounted rates. Please email meetings@topra.org before booking.

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Terms and conditions

By booking a place on this course you are agreeing to the Training Terms and Conditions.
When
28/09/2027 - 29/09/2027
Where
TOPRA 3rd Floor City Reach 5-6 Greenwich View Place London E14 9NN UNITED KINGDOM
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