Getting the CMC Dossier Right

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 and provide a brief introduction to biologics.

: 11-12 September 2019
Where: etc. venues Farringdon - The Hatton, 51-53 Hatton Garden, London EC1N 8HN
Day 1: 09:00–16:45 | Day 2: 09:00–16:30  

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
  • Meet and 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.


The latest course programme can be downloaded here. 

Past presenters include 

All TOPRA CRED courses are taught by experts with real-life, practical knowledge and experience. Past presenters for this course have included experts from ERA Consulting, AstraZeneca Mylan, from MHRA and MEB

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)


Course *fees:
Type Member Non-member 
Standard    £925+VAT  £1,095+VAT

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
 £462.50+VAT  £547.50+VAT

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

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Next steps

11/09/2019 - 12/09/2019
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On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

However, if for any reason you do not wish TOPRA to use your image or voice please let us know

Recording and photography by delegates is not permitted.