Registering Biological Biotech and Advanced Therapy Products

Registering Biological Biotech and Advanced Therapy Products
This Masterclass is 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, products, which provide challenges with their inherent complexities. The module includes consideration of the data requirements for clinical trial applications and marketing applications. This is also Module 9 of the TOPRA MSc Regulatory Affairs: The lecturers are highly experienced professionals in their field of work.



When
: 3-5 April 2019
Where: De Vere Latimer Estate, Chesham, HP5 1 UG, UK
Start Day 1: 16.00 End Day 3: 16.00

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.
 
 

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 19 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
 
 

Programme

The latest course programme can be downloaded here

Module Leader

Alexis Cockroft - Lex Regulatory

Presenters

Presenter list for this event to be announced.

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.

 

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  

    Course fees:
    Type Student Delegate
    Standard    £1500+VAT £1700+VAT 

    Discounted places
    A limited number of discounted places are available at the rates below. 
    Please email us at meetings@topra.org for a discount code before making your booking.

    Those working for regulatory agencies, government agencies or academic institutions 
                                       
     £1275+VAT
    Those working for charities, patient groups or in full-time education
       £1275+VAT

    • VAT, if applicable, is charged at the rate of 20% 
    • The registration fee does not include accommodation 
    • Refreshments, lunch and evening meal are included in the registration fee

    Related courses

    Next steps

    Module 10: Leadership and Strategic Management in Regulatory Affairs

    Terms and conditions

    Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions
    When
    03/04/2019 16:00 - 05/04/2019 16:00
    Where
    De Vere Latimer Estate Chesham HP5 1UG UNITED KINGDOM
    Your VAT country
    Your Vat number
    NOTE
    If your company 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

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