ATMP's Quality by design from bench to clinic

1 Day/s

CPD Hours: 7

Online, In-house

This course defines the current key regulatory requirements for advanced therapeutic medicinal product (ATMP) development to the clinical trial and market authorisation application.


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 this one day course 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.


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


  • QPs looking to development their knowledge in AMTPs
  • Trainee QPs looking to development their knowledge in
  • R&D development and technical transfer to GMP production of ATMPs
  • Quality aspects of ATMP development and manufacturing e.g Quality assurance and quality control persons
  • Manufacturing of ATMPS, e.g. GMP managers and GMP production persons
  • analytical and microbiological testing of ATMPs (QC laboratory persons)
  • process engineering developments for ATMPs
This course is designed to cover a knowledge base from legal definitions through development of a :


  • Introduction to ATMPs
    • ATMP definition in laws
    • Borderline products – discussion and evaluation
    • Other relevant legislation and guidance
  • Research and development
    • Plasmids, vectors and process development
    • Analytical method development
    • Microbiologic assay development
  • Good manufacturing and distribution practices of ATMPs
    • Facility design – Annex I etc considerations
    • Other relevant legislation
    • Discussion of ICH guidelines and regulatory compliance within the EU and Northern American (FDA)
    • Moving of your product from manufacturing to clinic
  • Route from bench to market
    • Preparation of regulatory documentation
    • Interacting and working with local and international competent authorities
    • The role of auditing in the development and manufacture of ATMPs
    • Considering phase III development to springboard you to MAA

    At the end of this course you will have learned :


    • Understand the basics of ATMPs and their categories
    • Key factors to consider with your process development from bench to clinic
    • Good manufacturing Practices (GMP), preparation and submission of Investigative Medicinal Product Dossiers (IMPD)
    • Investigator Brochures (IB), quality, potency and stability assessment of your product.
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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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