This course is also available to attend online
When: 6 May 2026
Where: TOPRA Office, 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Time: 09:00 –17:00 BST
CPD: 8 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Regulatory, CMC, quality, and development professionals seeking to confidently manage vaccine development from early process design to lifecycle management.
What you'll learn
By completing this course, you will be able to gain:
- Real-world case studies illustrating CMC, non-clinical, and clinical integration.
- Insights into how regulators evaluate data across all three domains.
- Actionable strategies for navigating global regulatory pathways from early development through licensure.
Course overview
The course will provide a clear, concise, and practical overview of the regulatory and technical requirements for modern vaccines, covering CMC (Chemistry, Manufacturing, and Controls), non-clinical, and clinical aspects across traditional, recombinant, vector-based, and mRNA platforms.
Participants will learn about:
CMC Requirements
- Global regulatory expectations (FDA, EMA, WHO) for vaccine manufacturing processes.
- Analytical methods, control strategies, stability programs, viral safety, and comparability data.
- Common CMC challenges and strategies for building a robust, globally compliant dossier.
Non-Clinical Requirements
- Preclinical study design for immunogenicity, safety, and toxicology.
- Animal models and bridging studies for novel platforms.
- Regulatory guidance on non-clinical data packages for first-in-human trials.
Clinical Requirements
- Clinical trial phases for vaccines: design, endpoints, and statistical considerations.
- Challenges and novel approaches to clinical trial design
- Safety monitoring, immunogenicity assessment, and correlates of protection
Course presenters
-
Cecil Nick, Vice President (Technical) at Parexel International
- Zeb Younes, Chief Regulatory Officer, CMC at Granata Bio
- Maria Beatrice Panico, Deputy Chief Medical Officer & Principal Medical Consultant at Scendea
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£650.00 + VAT* |
Standard Price
Non-member |
£910.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to all attendees, regardless of your country of origin. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.