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Press Release

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

Research and Markets
Posted on: 20 Dec 17

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

View source version on businesswire.com: http://www.businesswire.com/news/home/20171220005532/en/

Business Wire
www.businesswire.com

Last updated on: 20/12/2017

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