When: 2-3 September 2025
Where: TOPRA 3rd Floor, City Reach. 5-6 Greenwich View Place, London, E14 9NN
Time: Start time (day 1) 09:00 & End time (day 2) 16:45 BST
This course is also available to attend in person.
Suitable for
This course is designed for those:
- 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 information
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
- 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
Please see last year's programme here.
Presenters
- Chris Carr, Bio Products Laboratory Limited
- Sargon Daniel, Consultant, Aimmune Therapeutics
- Olivier Dirat, Senior Director - Brands CMC Team Leader and CMC Advisory Office, Pfizer
- Bethany Jackson, Respiratory Biologic Account Specialist, AstraZeneca
- Paul Marshall, Director CMC Regulatory Affairs, OTSUKA PHARMACEUTICAL EUROPE LTD
- Christian Monnerjahn, Regulatory Affairs Manager/ Informationsbeauftrager §74a AMG, Eckert & Ziegler Radiopharma GmbH
- Bassel Odeh, Head of New Active Substances, MHRA
- Sharon Page, Director CMC Strategy, Pfizer
- Alejandro Monton Silva, Medicines Evaluation Board (MEB)
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,050.00 + VAT* |
Standard Price
Non-member |
£1,250.00 + VAT* |
Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£787.50 + VAT* |
Government or academic rates
Non-member
|
£937.50 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£525.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£625.00 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.