Presented by
Management Forum

Pharmaceutical Development of ATMPs

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

25-26 Apr 2022 + 2 more dates

Enrol now

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Pharmaceutical Development of ATMPs course will cover:

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

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Book Pharmaceutical Development of ATMPs Live online/Classroom training

25-26 Apr 2022

Live online

09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 11584

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 21 Mar

In your basket 

13-14 Jul 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11830

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 08 Jun

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

6-7 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11745

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 01 Sep

In your basket 

Reviews of IPI's Pharmaceutical Development of ATMPs training course


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

Oct 5 2020

Rehab Alnabhan
Miltenyi Biotec B.V. & Co. KG

Oct 5 2020

I am very pleased with the webinar.

Astrid Beck Vestergaard
Quality Assurance, Cytovac

Oct 5 2020

I feel the content was detailed and informative.

Anisa Mohamed
Regulatory Affairs Officer, Welsh Blood Service

Oct 7 2019

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

Apr 4 2019

Great and really interesting.

Heloise Armand
Quality Director, Genzyme Polyclonals

Apr 4 2019

Very good!

Marie-Charlotte Royer
Quality Engineer, Urgo RID

Apr 4 2019

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

Oct 2 2018

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

Elizabeth Watson
Scientific Writer, Hookipa Biotech

UK

  • Autolus Ltd
  • CHI
  • Gammadelta Tx
  • Gilead Sciences International Ltd
  • GSK
  • Janssen Research and Development
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MeiraGTx
  • SARQ Pharma Ltd
  • University of Brighton
  • Welsh Blood Service

Netherlands

  • Astellas Pharma
  • Astellas Pharma Europe B.V.
  • Astellas Pharma Europe BV
  • Dorian Regulatory Affairs BV
  • Erasmus MC
  • Erasmus Medical Center Rotterdam
  • myTomorrows

France

  • Becton, Dickinson and Company
  • Genzyme Polyclonals
  • Sanofi R&D
  • Sanofi-Aventis R&D
  • Urgo RID
  • UrgoRID

Denmark

  • Cytovac
  • Novo Nordisk
  • Novo Nordisk A/S

Switzerland

  • CSL Behring AG
  • Sakk
  • University of Zurich

Germany

  • CSL Behring GmbH
  • Miltenyi Biotec B.V. & Co. KG

Sweden

  • Amniotics AB
  • BioLAmina AB

Afghanistan

  • Saudi Food and Drug Authority

Austria

  • Hookipa Biotech

Belgium

  • ELECTS

Ireland

  • Biomarin Pharmaceuticals Inc.

Israel

  • Aummune

Saudi Arabia

  • Saudi Food and Drug Authority

Slovenia

  • Educell

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy