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Pharmaceutical Development of ATMPs

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

Course overview

This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).

Industry expterts will cover the regulatory landscape and the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. The differences between GMP for ATMPs and conventional therapies will be discussed, as will the requirements for clinical trials and the preparation of the IMPD. Advice on the specific transportation requirements of these products will also be addressed.

This programme will be of benefit to all those involved with or considering developing an ATMP.

Benefits of attending:

  • Understand the GMP requirements for clinical trials 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 and understand Annex 16
  • Gain an introduction to GMO approval requirements

This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.

Who should attend?

  • 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

Programme

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, eg Tissues and Cells Directives (2002/98/EC and 2004/23/EC); Medical Device 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
  • Understanding breakthrough status/PRIME

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

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

Understanding clinical trials

  • EU clinical trial requirements
  • The US IND

Risk-based approach for ATMPs

  • Examining 3.2.A Adventitious Agents
  • Level of data required EU/US

GMP for ATMPs

  • What is required: examine the major differences between GMP for ATMPs and conventional therapies
  • Overcoming potential pitfalls when manufacturing cells
  • Current GMP interpretations
  • Multiple manufacturing sites for autologous products
  • Point-of-care preparation devices

Stability and logistics

  • Considering stability issues
  • Challenges in transporting cell therapies/cryopreservation
  • Preparation on site

Clinical trial considerations

  • 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 IMPD

  • Terms and definitions
  • Guidance on IMPD content for ATMPs
  • Data requirements for first-in-human vs later clinical trials

Customise

Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 25-26 Apr 2022
  • 13-14 Jul 2022
  • 6-7 Oct 2022

Book now

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Previous customers include...

  • Amniotics AB
  • Astellas Pharma
  • Astellas Pharma Europe B.V.
  • Astellas Pharma Europe B.V. (EU 10)
  • Autolus Ltd
  • Becton, Dickinson and Company
  • BioLAmina AB
  • CHI
  • CSL Behring AG
  • CSL Behring GmbH
  • Cytovac
  • ELECTS
  • Erasmus MC
  • Gammadelta Tx
  • Genzyme Polyclonals
  • Gilead Sciences International Ltd
  • Hookipa Biotech AG
  • Janssen Research and Development
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MeiraGTx
  • Miltenyi Biotec B.V. & Co. KG
  • myTomorrows
  • Novo Nordisk
  • Novo Nordisk A/S
  • Sakk
  • SARQ Pharma Ltd
  • Saudi Food and Drug Authority
  • University of Brighton
  • University of Zurich
  • Welsh Blood Service

I feel the content was detailed and informative.

Anisa Mohamed, Regulatory Affairs Officer, Welsh Blood Service, Oct 20

I am very pleased with the webinar.

Astrid Beck Vestergaard, Quality Assurance, Cytovac, Oct 20

I liked Andrew's teaching methods mainly engagement of participant all the way through the course.

Rehab Alnabhan, Miltenyi Biotec B.V. & Co. KG , Oct 20

I liked the course and have already recommended it to my colleagues. The content was very interesting, a lot was covered, and it was really convenient to read everything again at home and have some kind of "handbook" to look into. Both speakers were excellent and useful and clear answers were always given. They always tried to include all attendees and address their specific working areas during the course, which was really great.

Lisa Grabner, Quality Manager Projects, University of Zurich, Oct 19

I think Andrew Willis was very entertaining. and had good answers. Maybe even more examples from real life would be good.

Ida Kjær, QA Professional, Novo Nordisk A/S, Apr 19

Very good!

Marie-Charlotte Royer, Quality Engineer, Urgo RID, Apr 19

Great and really interesting.

Heloise Armand, Quality Director, Genzyme Polyclonals, Apr 19

Great depth of experience. Well presented, very intense and in-depth material.

Elizabeth Watson, Scientific Writer, Hookipa Biotech, Oct 18