This course is also available to attend in-person
When: 28–29 September 2027
Where: Online
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.
Important Notice On VAT
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.