When: 15 - 17 May 2023
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Day 1 start time: 09:00 BST | Day 3 end time: 15:15 BST
Also available as a virtual course, please click here for the virtual registration option.
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 principals
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.
Great overview of an area in the pharmaceutical industry that not many are exposed to. Biological, biotechnology and ATMP are the future so all in the pharmaceutical industry should know about this topic.” – 2018 delegate
Benefits to delegates
This course will enable you to:
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.
- 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
You can view and download an example programme based on previous courses here
- Rhydian Howells – Senior Manager, KPMG Life Sciences Regulatory Solutions Practice
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(s) listed above, previous speakers for this
Mark Richardson - Consultant, Richardson Associates
Richard Keane - Sr Director, Head of Global Regulatory CMC Commercial Products, Biogen
Tara Hutton - Director, Biogen
Alison Wolfreys - Senior Director, UCB
Anne Stokes - Director TSE and Virus Control for Biopharmaceuticals, GSK
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
- 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
- Student: 1,500£ + VAT*
- Delegate: 1,700£ + VAT*
A limited number of discounted places are available at the rates below. Please note that discounted places are not valid for those enrolled on the MSc course.
Please email us at firstname.lastname@example.org for a discount code before making your booking.
* VAT, if applicable, is charged at the rate of 20%
- Those working for regulatory agencies, government agencies or academic institutions: 1,275£ + VAT*
- Those working for charities, patient groups or in full-time education: 1,275£ + VAT*
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.