DUBLIN--(BUSINESS WIRE)--The "Pharmaceutical Development of ATMPs" conference has been added to Research and Markets' offering.
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Agenda:
Day one
Quality considerations for ATMPs
- Introduction to ATMPS
- Definition of ATMPs and associated terms
- Classification of ATMPs
The regulatory landscape
- Examining the European regulatory landscape for ATMPs - detailed analysis of existing regulation 1394/2007
- Considering factors lying outside of the regulation's scope, e.g. combination products
- Links to related directives, e.g. Tissues and Cells Directives (2002/98/EC and 2004/23/EC); medical devices directive (93/42/EEC) and forthcoming regulation
Strategic considerations
- Opportunities to meet with regulators to maximise approval chances
- ATMP-specific options in the EU: certification procedure, risk-benefit approach
- - Accelerated access opportunities in EU and US
Insight into global regulations and requirements
- Examining key markets including Europe, US and Japan
- Evaluate the regulatory differences between regions to help you build a strategic approval route
- GMP requirements at Phase I in US and Europe - ramifications for your product
- Conditional licencing in Japan - possible potential for you?
- Practical insight into other markets: South Korea
Overcoming quality challenges
- Overview of frequent quality concerns
- Potency assay development
- Determining critical quality attributes
- Developing a successful QC strategy for short shelf-life product
- QP release: timing and logistical challenges for ATMPs
Day two
GMP and GCP for ATMPs
GMP for ATMPs
- What is required: examine the major differences between GMP for ATMPs and conventional therapeutics
- Overcoming potential pitfalls when manufacturing cells
- Current GMP interpretations
- Multiple manufacturing sites for autologous products
- Point-of-care preparation devices
Delivery and shipping
- Considering stability issues
- Challenges in transporting cell therapies/cryopreservation
- Preparation on site
Preparation for clinical trial
- Optimising materials for regulatory compliance - vendor qualification
- Risk analysis for biological materials
- The comparability concept and its importance in preparing for clinical trials
- Introduction to GMO approval requirements
Practical considerations for the Investigational Medicinal Product Dossier (IMPD)
- Terms and definitions
- Guidance on IMPD content for ATMPs
- Data requirements for first-in-human vs later clinical trials
For more information about this conference visit https://www.researchandmarkets.com/research/xzrck8/pharmaceutical?w=4
