DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Development of ATMPs" conference has been added to ResearchAndMarkets.com's offering.
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
The programme will cover the regulatory landscape, the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. Comparison of the differences between GMP for Advance Medicinal Therapeutic Product (ATMPs) and conventional therapeutics will be discussed. Consideration of what is required for clinical trials and the preparation of the IMPD will also be addressed. Furthermore advice on the specific transportation requirements of these products will be included.
This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.
Benefits of attending:
- Understand the GMP requirements at Phase 1 in US and Europe
- Gain a practical insight into other markets
- Determine critical quality attributes
- Develop a successful QC strategy
- Examine the major differences between GMP for ATMPs and conventional therapies
- Overcome potential pitfalls when manufacturing cells
- Discuss multi manufacturing sites for autologous products
- Consider stability issues
- Examine risk analysis for biological materials
- Gain an introduction to GMO approval requirements
Agenda
Day 1
- Quality considerations for ATMPs
- The regulatory landscape
- Strategic considerations
- Insight into global regulations and requirements
-
Overcoming quality challenges
Day 2
- GMP and GCP for ATMPs
- GMP for ATMPs
- Delivery and shipping
- Preparation for clinical trial
- Practical considerations for the Investigational Medicinal Product Dossier (IMPD)
For more information about this conference visit https://www.researchandmarkets.com/research/wzrgjt/2_day_course?w=4
