When: 5-6 October 2022
Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom
Start time day 1: 08:45 GMT
End time day 2: 16:30 GMT
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
- Participate in case studies and interactive lessons - learn by doing
- Have the opportunity to interact with speakers from Regulatory Agencies in a neutral environment
- 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.
Please view last year's programme here.
Presenters for this course will be announced closer to the start date. Past presenters have included:
- 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)
- Member: £925+VAT*
- Non-member: £1,095+VAT*
A limited number of discounted places are available at the rates below. Please email us at email@example.com 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.