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.
Key Topics
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
Who should Attend
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
