Presented by
Management Forum
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 (13)"
14-15 October 2024
+ 3-4 February 2025, 17-18 June 2025, 13-14 October 2025 »
from £1099
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:
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
14-15 October 2024
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 13928
Not ready to book yet?
for 7 days, no obligation
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
Until 30 Dec
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
Until 13 May
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
Until 08 Sep
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.
Structured and balanced approach in the order of CTD modules enabled a clear understanding on development and quality, regulatory expectations.
Jun 20 2023
Ramanathan Srinivasan
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
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
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
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
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
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
United Kingdom
Netherlands
France
Denmark
Germany
Switzerland
Belgium
Sweden
Afghanistan
Austria
Finland
Ireland
Israel
Saudi Arabia
Slovenia
Ukraine
2 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: