Pharmaceutical Development of ATMPs is a conference dedicated to regulatory landscape, the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges.
Pharmaceutical Development of ATMPs covers topics such as:
- The regulatory landscape
- Considering factors lying outside of the regulation`s scope, e.g. combination products
- Examining the European regulatory landscape for ATMPs - detailed analysis of existing regulation 1394/2007
- 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
- Quality considerations for ATMPs
- Definition of ATMPs and associated terms
- Introduction to ATMPS
- Classification of ATMPs
- Insight into global regulations and requirements
- Evaluate the regulatory differences between regions to help you build a strategic approval route
- Examining key markets including Europe, US and Japan
- Conditional licencing in Japan - possible potential for you?
- GMP requirements at Phase I in US and Europe - ramifications for your product
- Practical insight into other markets: South Korea
- Strategic considerations
- ATMP-specific options in the EU: certification procedure, risk-benefit approach
- Opportunities to meet with regulators to maximise approval chances
- Accelerated access opportunities in EU and US
- GMP for ATMPs
- Overcoming potential pitfalls when manufacturing cells
- What is required: examine the major differences between GMP for ATMPs and conventional therapeutics
- Multiple manufacturing sites for autologous products
- Current GMP interpretations
- Point-of-care preparation devices
- Overcoming quality challenges
- Potency assay development
- Overview of frequent quality concerns
- Developing a successful QC strategy for short shelf-life product
- Determining critical quality attributes
- QP release: timing and logistical challenges for ATMPs
- Preparation for clinical trial
- Risk analysis for biological materials
- Optimising materials for regulatory compliance - vendor qualification
- Introduction to GMO approval requirements
- The comparability concept and its importance in preparing for clinical trials
- Delivery and shipping
- Challenges in transporting cell therapies/cryopreservation
- Considering stability issues
- Preparation on site
- Practical considerations for the Investigational Medicinal Product Dossier (IMPD)
- Guidance on IMPD content for ATMPs
- Terms and definitions
- Data requirements for first-in-human vs later clinical trials
Pharmaceutical Development of ATMPs brings together:
- Managers involved in the development and manufacture of ATMPs
- R & D personnel involved in research on cell or gene based therapies
- GMP managers responsible for implementing GMP in ATMP manufacture
- Quality assurance and quality control personnel responsible for quality aspects of ATMPs
- Regulatory personnel involved in inspections of ATMPs
Pharmaceutical Development of ATMPs will be held on 18-19 Jun 2024.
