Registering Biological Biotech & Advanced Therapy Products

Registering Biological Biotech & Advanced Therapy Products
Module 9 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation and scientific principles underpinning development of biological, biotechnology and advanced therapy products, which provide challenges with their inherent complexities. The module includes consideration of the data requirements for clinical trial applications and marketing applications.


When: 8 - 10 September 2026
Where: TOPRA Office,3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: 10:30 BST | Day 3 end time: 16:30 BST

This course is also available to take part in online

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of biological, biotech and advanced therapy products
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject 


Course information

This Masterclass covers:
  • Different classes of biological products such as vaccines, monoclonal antibodies and gene therapy medicinal products
  • Practical regulatory aspects of regulatory strategy for biological, biotechnology and advanced therapy products
  • Regulatory Requirements for clinical trial applications and marketing applications
  • The quality, non-clinical and clinical changes specific to biological products
  • Implications of changes to the production of biological products and the concept of compatibility
  • Case studies to apply the regulatory principles

The combination of lectures and case studies and workshops will assist in the achievement of the learning outcomes and enable the students to contextualise their understanding and knowledge. 



Benefits to delegates

This course will enable you to: 

  • Display a systematic understanding of knowledge and a critical awareness of the unique nature and strategies for development of biological, biotechnology and advanced therapy products
  • Possess a comprehensive understanding of the regulatory requirements and associated documentation with the licencing of biological, biotechnology and advanced therapy products
  • Demonstrate a conceptual understanding of the legal and pharmaceutical requirements that define the regulatory strategy for biological, biotechnology and advanced therapy products
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non specialist audiences regarding biological, biotechnology and advanced therapy products
  • Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of biological, biotechnology and advanced therapy products
  • Critically appraise and evaluate communications from regulatory bodies and research publications regarding biological, biotechnology and advanced therapy products
CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page. 

Programme

You can download a draft programme here.

Module Leader

IPI Academy faculty: Rhydian Howells | IPI Academy

Rhydian Howells
Group Head, Regulatory CMC, ProPharma Group

Presenters

TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.

In addition to the module leader listed above, speakers for this course include:

Richard Keane, Sr Director, Head of Global Regulatory CMC Commercial Products, Biogen
Tara Hutton, Director, Biogen
Alison Wolfreys, Senior Director, UCB
Cecil Nick, Vice President, Parexel
Paula Urquhart, Senior Assay Development Scientist, Covance
Andrew Deavin, Director Vaccine Global Regulatory Affairs Asia Pacific and China, GSK Vaccines
Sergio Fracchia, Global regCMC Director Cell and Gene Therapy,Novartis
Zabin Younes, Scendea
Isabelle Cludts, MHRA

This course is suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of biological, biotech and advanced therapy products
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject 

Pricing


 Standard training course registration fees
 Event Registration Type Price (GBP)
 Standard Price 
 TOPRA Member		 £1,900.00 + VAT*
 Standard Price
 Non-member		 £2,375.00 + VAT* 
 TOPRA MSc Students
  		 £1,650.00 + 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
 £1,425.00 + VAT*
 Government or academic rates 
 Non-member
 £1,781.25 + VAT*
 Charities, patient groups, full-time education rates
 TOPRA Member		 £950.00 + VAT*
  Charities, patient groups, full-time education rates
  Non-member
  £1,187.50 + 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%.
 

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

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.
When
08/09/2026 - 10/09/2026
Where
TOPRA Office 3rd Floor City Reach 5-6 Greenwich View Place London E14 9NN UNITED KINGDOM
Registration begins 31/08/2025
My registration status: Not registered
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Register now