Introduction to ATMPs and route to market

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1 Day/s

CPD Hours: 7

Online, in-house

This course discusses the key regulatory requirements and issues surrounding developing and translating an advanced therapeutic medicinal product (ATMP) 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.


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


  • Managers involved in the development and GMP translation of ATMPs
  • Quality assurance and control staff working with quality aspects of ATMP development
  • GMP managers and GMP production staff working with the manufacturer of ATMPs
This course is applicable to those considering or currently in the process of developing ATMPs and covers:


  • Introduction to ATMPs
    • ATMP definition and classes
  • Research and development
    • Taking your idea from concept to manufacture
    • Defining potency assays
    • Stability programme development
    • Need for pre-clinical data in ATMP development
    • Continuous process development
  • Good manufacturing and distribution practices of ATMPs
    • 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

Lindsay Davies

Lindsay’s career in the life science arena spans over 15 years, with firsthand experience in preclinical research, clinical trial design and product development within the field of cell therapy and regenerative medicine. Lindsay has experience within both the academic and industrial sectors, working as Chief Scientific Officer of a cell therapy company and Associate Professor in Stromal Cell Biology at The Karolinska Institute in Sweden. She has been presented with multiple awards for her research and is the named inventor on numerous granted patents for her research. She has extensively published in the field of regenerative medicine and the use of advanced therapies (ATMPs) for immune mediated disorders including Graft versus Host Disease, and Type I Diabetes.

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Good clinical practice for ATMPs

This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP) specific to ATMPs.

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