Pharmaceutical Development of ATMPs

  • 03-04 Feb 2025
  • 17-18 Jun 2025
  • 13-14 Oct 2025
  • Webinar

Description

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.

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

More Details

Prices:
1099-1299 Pound Sterling (Estimated)
Organizer:
Management Forum
Website:

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Important

Please, check "Pharmaceutical Development of ATMPs" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Science: Health sciences, Life Sciences & Biology

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