An overview of the European Legislation for Advanced Therapies Medicinal Products (ATMPs), displaying the different Regulations and Directives that define and classify advanced therapies, the marketing authorisation procedure of ATMPs at EMA, compassionate use and hospital exemption.
A walkthrough of different interactions and procedures available at the EMA to support the development of Advanced Therapy Medicinal Products (ATMPs) such as ATMP Classification Procedure, PRIME Scheme, Orphan Designation, Innovation Task Force meetings and Scientific Advice. Their requirements, how to apply for them and how developers would benefit. Overview on different national Scientific Advice procedures.
Discussing the most common quality challenges faced in the development of Advanced Therapy Medicinal Products: Starting Materials, Characterisation, Comparability, Potency and Viral Safety. Considerations to work around them to avoid possible issues.
Reviewing the Good Manufacturing Practices requirements for ATMPs as displayed in the GMP Guidelines: EudraLex Volume 4, Part IV: Good Manufacturing Practice specific to Advanced Therapy Medicinal Product.
An explanation on the Clinical Trial Application (CTA) procedure with the types of documents and information to be included. The implications of the new Clinical Trials Information System (CTIS) and the content of the CTA, the Investigational Medicinal Product Dossier (IMPD) and Amendments on these documents.
A scientific look on the different types of advanced therapies: gene therapies, somatic cell therapies, tissue engineered products and combined products. Examples of previous advanced therapies approved by EMA and cases studies of classifications of ATMPs.
