ATMP Webinar

90.00 Minutes

CPD Hours: 1

Online

This series of webinars introduces the key regulatory requirements and issues surrounding developing and manufacturing an advanced therapeutic medicinal product (ATMP).


ATMPs represent a growing number of therapeutics entering clinical development and market authorisation application (MAA). This cutting edge therapeutic area sits with an evolving area of legislation. During the webinars, you will be introduced to ATMPs and their categories, key factors to consider with your process development from bench to clinic including Good manufacturing Practices (GMP), preparation and submission of Investigative Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB), quality, potency and stability assessment of your product.


There are six webinars in the series and the first three webinar topics are as follows :


  • March – ATMP, what are they and what do the laws say
    Further details
    • This webinar will provide the relevant legislation and some worked examples where products fall in or out of scope of the legal definition of an ATMP. Topic areas covered in the webinar include:
      • Current EU / UK GMP legislation definitions of ATMP
      • Interdependencies of other relevant legislation
      • Borderline product considerations


  • May – ATMP Facility design and method development
    Further details
    • This webinar will provide relevant legislation and other guidance documents for facility construction, some considerations for analytical method development and regulatory guidance in this area. Topic areas we cover include:
      • Facility design requirements
      • Practical considerations and watch outs
      • Analytical method development legislation and guidance
      • Microbiological method considerations


  • July – ATMP scale out scale up and decentralised manufacturing
    Further details
    • This webinar will provide key topics for consideration when moving through ATMP product lifecycle and the key challenges for each option. Topic areas covered in the webinar include:
      • Current GMP legal requirements
      • Practical considerations and watch outs
      • Future proofing considerations



Don't miss this opportunity to uncover the intricacies of ATMPs and get a taste of what our upcoming course has to offer. Secure your spot now by registering.


The course is suitable for any research and development staff working with ATMP process development. This would include, but not limited to:


  • Professionals in the pharmaceutical and biotechnology industries
  • Quality assurance and control staff working with quality aspects of ATMP development
  • GMP managers and GMP production staff working with the manufacturer of ATMPs
  • Researchers and scientists interested in the field of ATMP
  • Regulatory affairs specialists
  • Anyone looking to enhance their knowledge of cutting-edge medical therapies

There are six webinars in the series and the first three webinar topics are as follows :


  • March – ATMP, what are they and what do the laws say
    Further details
    • This webinar will provide the relevant legislation and some worked examples where products fall in or out of scope of the legal definition of an ATMP. Topic areas covered in the webinar include:
      • Current EU / UK GMP legislation definitions of ATMP
      • Interdependencies of other relevant legislation
      • Borderline product considerations
  • April – ATMP Facility design and method development
    Further details
    • This webinar will provide relevant legislation and other guidance documents for facility construction, some considerations for analytical method development and regulatory guidance in this area. Topic areas we cover include:
      • Facility design requirements
      • Practical considerations and watch outs
      • Analytical method development legislation and guidance
      • Microbiological method considerations
  • May – ATMP scale out scale up and decentralised manufacturing
    Further details
    • This webinar will provide key topics for consideration when moving through ATMP product lifecycle and the key challenges for each option. Topic areas covered in the webinar include:
      • Current GMP legal requirements
      • Practical considerations and watch outs
      • Future proofing considerations

    By attending the webinars, you will be able to:


    • List the relevant current GMP legislation
    • Detail practical considerations for design requirements
    • Recognise risks
    • Analyse other relevant legislation
    • Identify GMP requirements in the product lifecycle
    • Gain a sneak peek into the comprehensive content of our ATMP course
    • Network with industry experts and like-minded professionals
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Meet the tutors

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person (Eligible to act as a Qualified Person under the permanent provisions) with expertise with Biotechnology products and provision of support for Advanced Therapy Medicinal Products (ATMP). She has held Director positions at some of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

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