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Pharmaceutical Development of ATMPs Training Course

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

14-15 Jul 2022

& 6-7 Oct 2022

Book now

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

Presenter

Andrew Willis (More...)

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Book now

Book now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
14-15 Jul 2022
Live webinar
09:00-16:45
UK (London)
14-15 Jul 2022
Live webinar
09:00-16:45
UK (London)
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
6-7 Oct 2022
Live webinar
09:00-16:45
UK (London)
6-7 Oct 2022
Live webinar
09:00-16:45
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 1 Sep*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

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

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Amniotics AB
  • Astellas Pharma Europe B.V.
  • Astellas Pharma Europe B.V. (EU 10)
  • Aummune
  • Autolus Ltd
  • BioLAmina AB
  • Biomarin Pharmaceuticals Inc.
  • CHI
  • CSL Behring AG
  • CSL Behring GmbH
  • Dorian Regulatory Affairs BV
  • Educell
  • Erasmus MC
  • Erasmus Medical Center Rotterdam
  • Gammadelta Tx
  • Genzyme Polyclonals
  • Gilead Sciences International Ltd
  • GSK
  • Hookipa Biotech AG
  • MeiraGTx
  • Miltenyi Biotec B.V. & Co. KG
  • myTomorrows
  • Novo Nordisk A/S
  • NovoNordisk A/S
  • Sakk
  • Sanofi Aventis Recherche et Développement
  • SARQ Pharma Ltd
  • StemSight
  • University of Brighton
  • University of Zurich

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 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 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