Navigating ATMP Development - Live Online Training

The development of advanced therapy medicinal products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products, is characterized by a high level of scientific, technical, and regulatory complexity. These innovative medicinal products must comply with stringent and ever-changing regulatory requirements, as set out in various European and international guidance documents. Examples include the EMA Guideline on “Quality, non-clinical and clinical aspects of gene therapy medicinal products” (EMA/CAT/80183/2014), The guideline on “Human cell-based medicinal Products” (EMEA/CHMP/410869/2006), EudraLex Volume 4 Part IV for ATMPs and cross-cutting ICH guidelines, such as ICH Q8–Q10 (quality by design and pharmaceutical quality systems) and ICH Q14 (analytical procedure development).

The transition from preclinical research to first-in-human trials and later market authorization – often referred to as the “bench to bedside” process – requires a development strategy that integrates regulatory foresight, robust CMC (Chemistry, Manufacturing and Control) planning, and comprehensive quality oversight from the earliest stages. Particular challenges in ATMP development include raw material qualification, platform-independent process validation, aseptic processing strategies, and the implementation of analytical approaches in accordance with ICH Q14 principles. Upscaling and tech transfer into GMP-compliant manufacturing environments require strategic foresight and alignment with GMP for ATMPs (EudraLex Vol. 4 Part IV).

This training course provides participants with a practice-oriented understanding of the end-to-end ATMP development process. It offers in-depth insights into regulatory expectations, process and analytical development, validation strategies, and the specific responsibilities of the Qualified Person (QP) under EU legislation. Participants will develop confidence in applying risk-based approaches (as outlined in ICH Q9) and addressing critical regulatory interfaces during development and scale-up. The course provides professionals with the strategies and regulatory expertise needed to successfully implement, ensure GMP compliance and ultimately authorize ATMPs in a dynamic and highly regulated environment.