GMP for Advanced Therapy Medicinal Products (ATMPs)
Summary
Other
950 CHF
Excluding taxes, includes lunch, coffee and snacks. The payment is due prior to the training.
English
Biofactory Competence Center, passage du Cardinal 13b, Halle Bleue, 1700 Fribourg, Switzerland
A comprehensive approach from process development to manufacturing
Advanced Therapy Medicinal Products (ATMPs) represent the next frontier in medical innovation, offering groundbreaking treatments for previously incurable diseases. By harnessing the power of gene therapy, cell therapy, and tissue-engineered products, ATMPs have the potential to revolutionize patient care, providing personalized and highly effective therapies.
As demand for ATMPs increases, grasping the complex regulatory landscape and quality standards is essential for all involved in their development. The journey from initial starting materials to clinical application poses significant challenges, requiring navigation through a lengthy regulatory pathway. Stakeholders must address various obstacles across GMP, GDP and GCP all while adapting to shifting regulations and responsibilities. Effective management of these intersections necessitates flexible solutions within the regulatory and quality frameworks.
This course provides a comprehensive overview of current regulations for Advanced Therapy Medicinal Products (ATMPs) while tackling specific challenges in process development, technology transfer, and manufacturing aspects. Additionally, we share real-world examples and practical strategies to help navigate the complexities of regulatory compliance in the development and application of ATMPs.
Key Objectives
- Gain a comprehensive understanding of EU and CH legislation and GMP requirements for ATMPs.
- Familiarize with the standalone GMP regulation for ATMPs (Eudralex Vol. 4, Part IV) and its relationship with Annex 1 for sterile manufacturing.
- Learn about a specific strategy for ATMP process development
- Identify key elements for a successful technology transfer phase.
- Examine specific challenges related to manufacturing activities.
- Learn how to design a media fill using a bracketing approach that addresses aseptic risks across diverse manufacturing processes.
- Implement an effective Contamination Control Strategy (CCS).
Who should attend?
- Individuals involved in ATMP process development and manufacturing activities
- Interested people eager to enter the ATMP world
- Professionals responsible for the quality aspects of ATMPs
- Project managers working within the ATMP domain
- Individuals involved in auditing ATMP facilities and processes
Further information
Certification will be handed out to each participant at the end of course.
Travel and accommodation are not included in the course fee. Flights can be booked to either Geneva or Zurich airport with a direct train connection from both airports to Fribourg.
Are you interested in this training ? if so, please register by clicking on the following link:
Registration
Contact and informations :
Biofactory Competence Center
Passage du Cardinal 13b
1700 Fribourg
Switzerland
info@bcc.ch
Date
21 March 2025
Duration:
1 day (9h00-17h00)
Number of participants :
Min 5 - max 20