Regulatory Requirements for Cell Tissue & Gene Therapies

Regulatory Requirements for Cell Tissue &  Gene Therapies
Module 22 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products, which has grown in significance over the past five years. It fills a gap in the educational needs for contemporary regulatory affairs specialists. It will allow students to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved.

When
: 6-8 September 2023
Where: Online

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

Course overview

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products. Advanced therapy  medicinal include cell, tissue and gene therapies.  It will allow you to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved. 

Benefits to delegates

Lecturers and workshops will cover ATMP legislation, classification and certification, the importance of having a clear classification early in the regulatory process and borderlines between different types of ATMPs; Good manufacturing and good clinical practice; issues specifically relating to ATMPs; other relevant legislation that must be considered such as requirements for blood derivatives; the unique quality considerations for ATMPs such as the definition and characterisation of the starting materials, comparability and key specification tests; clinical and non-clinical considerations including the challenges with animal and disease model selection, immunotoxicity, GMO risk assessments and how drug-device combination products that incorporate ATMPs are handled.

Regulatory requirements for a range of different countries will be discussed such as the US, EU UK and Japan.

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable delegates to contextualise their understanding and knowledge.

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

  • Shaun Stapleton - Vice President Regulatory Affairs and PharmacovigilanceReNeuron Ltd

Speakers

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:

This course is suitable for

  • Delegates from the regulatory affairs industry who wish to develop their knowledge of advanced therapy and medicinal products.
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject

  • Pricing 

    Standard

    • Delegate: £1700+VAT*

    Discounted places

    A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: 1,275£ + VAT*.

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

    *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
      06/09/2023 - 08/09/2023
      Sign in or create an account to register Last day to register is 05/09/2023
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