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.


When: 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.

Programme

The latest course programme can be downloaded here. 

Presenters include 


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)

 
Pricing   

This course is now full, if you would like to be added to the waiting list, please mail meetings@topra.org. 

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 meetings@topra.org for a discount code before making your booking.

  
Those working for regulatory agencies, government agencies or academic institutions 
  £693.75+VAT
 £821.25+VAT 
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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When
11/09/2019 - 12/09/2019
Where
London UNITED KINGDOM
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