Educational Materials

Regulatory Courses

1. Introduction to Advanced Therapy Medicinal Products (ATMPs)

Audience:  For scientists, regulatory affairs managers, and other persons interested in learning about regulatory affairs principles, the development and marketing authorisation of Advanced Therapy Medicinal Products (ATMPs) in the EU.

Aims:  This webinar is an introduction to relevant categories of regulatory documents and regulatory Agencies in the EU including the European Medicines Agency (EMA) with its committees (especially the CAT). It provides an overview of regulatory framework, definitions and examples for ATMPs and related products. Options how to communicate and discuss questions with the regulatory agencies as well specific ATMP procedures are presented.

Content: 

    1. Understanding the regulatory framework for ATMPs and related products
    2. Definitions and examples for ATMPs
    3. Presentation of regulatory EU agencies incl. EMA and important EMA committees (CAT, CHMP and others) and how they connect to each other
    4. Innovation Task Force Meeting, National Advice and EMA Scientific Advice – communicate with the Agency!
    5. CAT Classification, Certification for ATMPs – further options for your development

2. Guidance to Classification of Medicinal Products, ATMPs and Devices

Audience: For regulatory experts and scientists interested in the development and marketing authorisation of Advanced Therapy Medicinal Products (ATMPs) in the EU.

Aims:

This webinar gives an overview of the different product classification options available for ATMPs and related products. It describes aspects to consider, decisions to make and the consequences for the marketing authorisation process. Focus is placed on the indication intervertebral disc degeneration and the iPSpine product, comprising induced pluripotent stem cells and smart biomaterials.

Content: 

    1. Medicinal products and medical devices: The Yin and the Yang of the medical world
    2. Where to allocate ATMPs and what differentiates them from other products
    3. Gene therapy, tissue engineered product, somatic cell therapy or neither? Define your ATMP subtype
    4. Combined forces: How to create a combined ATMP and why the matrix is so important in this process
    5. Who is who: Raw material, starting material, excipient or drug substance? Classify the individual components of your product
    6. What it looks like in real life: Highlights and examples from published classifications of the Committee for Advanced Products (CAT)