When: 5-6 October 2022
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.
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
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.
- 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
Download a copy of the course programme here.
- Alejandro Montón Silva, MEB
- Chris Carr, Bio Products Laboratory Limited
- Christian Monnerjahn, Eckert & Ziegler Radiopharma GmbH
- Francesca Buttigieg, PTC Therapeutics, Inc
- Graham Powell, Viatris
- Olivier Dirat, Pfizer
- Paul Marshall, Jazz Pharmaceuticals
- Peter Hamilton, AstraZeneca UK
- Sargon Daniel, Aimmune Therapeutics
- Vimal Patel, Regulatory CMC Expert
- 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)
- Member: £925+VAT*
- Non-member: £1,095+VAT*
A limited number of discounted places are available at the rates below. Please email us at firstname.lastname@example.org for a discount code before making your booking.
- Those working for regulatory agencies, government agencies or academic institutions:
- Members: £693.75+VAT
- Non-members: £821.25+VAT
- Those working for charities, patient groups or in full-time education:
- Members: £462.50+VAT
- Non-members: £547.50+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.