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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.

★★★★★ "Structured and balanced approach in the order of CTD modules enabled a clear understanding on develo... more (14)"

3-4 February 2025
+ 17-18 June 2025, 13-14 October 2025 »
from £1099

Need help? Enrol or reserve

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

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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.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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

Enrol or reserve

This course will cover:

Day 1
Day 2

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

Enrol or reserve

Andrew Willis
San Salvatore Training Ltd

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.

More details

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

3-4 February 2025

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 15249

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 30 Dec

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

17-18 June 2025

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 14758

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 13 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

13-14 October 2025

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 14998

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 08 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Pharmaceutical Development of ATMPs training course

Presenter is very knowledgeable and is able to communicate that. [I particularly enjoyed] small group, presenter stimulated interaction.

Oct 14 2024

Erik Gout Netherlands
Senior Consultant CMC, Venn Life Sciences ED B.V.

Jun 20 2023

Structured and balanced approach in the order of CTD modules enabled a clear understanding on development and quality, regulatory expectations.

Ramanathan Srinivasan United Kingdom
Senior Director, Viatris UK

Feb 6 2023

excellent Andrew is very knowledgeable and helped us a lot in clarifying most of the ATMP dev processes which are very complicated to link without a given roadmap of the interlinked events.

Andrea Sirianni United Kingdom
Project Manager, Cell & Gene Therapy (CGT)

Feb 6 2023

Andrew was very knowledgeable, provided clear answers with examples on any question he was asked and I consider his slides a treasure of information that one can continuously refer to in the future.

Panos Papoutsis United Kingdom
Project Manager, Cell & Gene Therapy (CGT)

Jun 20 2023

I enjoyed the speaker, Andrew is clearly very knowledgeable and made a good effort to keep the webinar interactive where he could.

Thomas Leyen Netherlands
External Manufacturing Manager, Pharming Group NV

Jul 14 2022

This course was very relevant to my current profession and it provided a deeper understanding of the challenges associated with cell-based therapy. I really enjoyed the content and the structure. I also liked how Andrew presented the course for day 1 which set the scene for day 2. Most of the presentations also had references and some extra readings, which I will have to go back and read more about. Despite the heaviness of some of the contents, Andrew was still engaging in his presentation. I felt included in the discussions, and I really enjoyed his way of making the course relevant to each participant.

Eugene Padi Denmark
Associate Scientist, Novo Nordisk

Oct 5 2020

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

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

Oct 5 2020

I am very pleased with the webinar.

Astrid Beck Vestergaard Denmark
Quality Assurance, Cytovac

Oct 5 2020

I feel the content was detailed and informative.

Anisa Mohamed United Kingdom
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 Switzerland
Quality Manager Projects, University of Zurich