Master the intricate compliance landscape governing Advanced Therapy Medicinal Products. Join this new course to learn about the GMP requirements for ATMPs used in clinical trials or for the market and elevate your expertise and shape the future of medicine with confidence.
In this course you will learn about the GMP requirements for Advanced Therapy Medicinal Products (ATMPs) used in clinical trials or for the market.
Advanced Therapy Medicinal Products (ATMPs) are a category of innovative and complex medical therapies that harness advanced technologies to manipulate or utilize living cells, tissues, or genes for therapeutic purposes. These cutting-edge therapies aim to treat, prevent, or diagnose diseases by targeting the underlying causes at the cellular and genetic levels. ATMPs include gene therapies, cell therapies, and tissue-engineered products hereby representing a paradigm shift in medical interventions.
Before we dig into the GMP requirements you will get an introduction to ATMPs from a scientific and regulatory point of view.
You will be provided with examples of ATMPs and their corresponding manufacturing processes. The similarities and differences between ATMPs and conventional biologics will be shown and discussed.
Besides an overview of global GMP guidelines for ATMPs we will have a special focus on the GMP requirements for the EU and the USA.
You will learn about the GMP requirements for both the facility, equipment, process, product, and personnel.
Furthermore, you will learn how to use Quality Risk Management to establish phase-appropriate procedures and SOPs.
Finally, you will get the chance to design your own compliant ATMP manufacturing process together with colleagues during the course.
The course ends with a small test.
The course language is English.
At the course you will meet:
Erik Steffensen, Managing Partner and Principal Consultant, Spot-on Pharma Consulting
• Managers working with development, manufacturing, quality control, or quality assurance of ATMPs
• Project managers working with development, manufacturing, quality control, or quality control of ATMPs
• Professionals and specialists working with development, manufacturing, quality control or quality assurance of ATMPs.
The course duration is 2 days. Accommodation is included.
Day 1: 09.00 - 21.00
• Definition of ATMPs
• Examples of ATMPs and their manufacturing processes
• High level overview of GMP regulation and guidelines for ATMPs
• Case: Design your own compliant ATMP manufacturing process
Day 2: 09.00 - 16.00
• Deep dive into the GMP regulation and the guidelines for ATMPs with a focus on both facility, equipment, process, product, and personnel
• Use of Quality Risk Management to establish phase-appropriate procedures and SOPs
The course will be a combination of interactive lectures and group work
The course language is English
The tutor are Danish i.e. questions can be asked both in Danish and in English.