Pharmaceutical Development of ATMPs (London, United Kingdom - April 26-27, 2018)

  • ID: 4435768
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: April 26-27, 2018
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Overcoming Regulatory, Quality and GMP Challenges

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

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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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
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  • R & D personnel involved in research on cell or gene based therapies
  • Managers involved in the development and manufacture of ATMPs
  • Quality assurance and quality control personnel responsible for quality aspects of ATMPs
  • GMP managers responsible for implementing GMP in ATMP manufacture
  • Regulatory personnel involved in inspections of ATMPs
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ADDRESS

The Rembrandt Hotel
11 Thurloe Place
London
SW7 2RS
United Kingdom


DIRECTIONS

Opposite V&A Museum.
Nearest underground station: South Kensington.

Note: Product cover images may vary from those shown
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