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: 
15 - 17 May 2023
Where: Online
Day 1 start time: 09:00 BST | Day 3 end time: 15:15 BST

Also available as a face-to-face course, please click here for the face-to-face registration option.

Course overview

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: 

  • 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 view and download an example programme based on previous courses here

Module Leader

  • Rhydian Howells – Senior Manager, KPMG Life Sciences Regulatory Solutions Practice

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(s) listed above, previous speakers for this course include:

Mark Richardson - Consultant, Ri
chardson 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

Suitable for

  • 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

    • Delegate: 1,700£ + VAT*

    Discounted places

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

    Discounted prices

    • 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*
    * VAT, if 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.

     

    When
    15/05/2023 - 17/05/2023
    Sign in or create an account to register Last day to register is 14/05/2023
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