Presented by
Management Forum
A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.
★★★★★ "The webinar content corresponded to what I was expecting ; I thought it was very good that Andrew as... more (12)"
28-29 November 2024
+ 6-7 February 2025, 3-4 June 2025, 15-16 October 2025 »
from £1099
It is a key post-marketing responsibility of the marketing authorisation holder (MAH) to keep dossiers up to date, and changes must be submitted as variations to the appropriate regulatory authority.
This interactive event will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures. The course will cover the latest variation regulations and offer guidance from an industry expert on how to optimise your regulatory procedures to help achieve faster approval. The programme will include filing tips and strategies with information and advice on creating a global dossier and implementation periods.
Practical sessions throughout the two days will provide an opportunity to discuss different scenarios and strategies with other participants.
Benefits of attending:
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
This course will be particularly relevant for those working in registration and regulatory affairs. It will also be of interest to anyone with an involvement in the variations process including QA, clinical safety and pharmacovigilance personnel.
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
28-29 November 2024
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13936
Until 24 Oct
Not ready to book yet?
for 7 days, no obligation
6-7 February 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 14472
Until 02 Jan
Not ready to book yet?
for 7 days, no obligation
3-4 June 2025
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 14719
Until 29 Apr
Not ready to book yet?
for 7 days, no obligation
15-16 October 2025
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 15103
Until 10 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.
The webinar content corresponded to what I was expecting ; I thought it was very good that Andrew asked the participants lots of questions as it made the webinar more enjoyable and engaging.
Feb 1 2024
Liz Hui
Regulatory Affairs Executive, Dermal Laboratories Ltd
Jun 10 2024
Very good webinar. The schedules were good and respected. The content meets my expectations
Sarah Bourgin
Associate Regulatory Affairs Specialist, Medtronic BioPharma Sàrl
Jun 10 2024
The speakers were highly engaging and delivered the content in an interactive manner, which greatly enhanced the learning experience. Their expertise and ability to facilitate discussion made the webinar both informative and enjoyable.
Dania Shriki
REGULATORY AFFAIRS OFFICER, Owlpharma Consulting, Lda.
Jun 10 2024
I was looking for a refresher on variation management in EU. This was provided in a very good and structured way, with several tips and tricks to consider when dealing with variations.
Veerle Leijnen
Senior RA Executive Manager, Nikkiso Belgium
Oct 12 2023
The presentation was great and the speakers have excellent knowledge on their field. I hope to join another webinar soon.
Mairi Zadik
CMC Regulatory Compliance Officer, Pharmathen
Jun 6 2023
What I liked most about Andrew was the inspiring way of explaining the various sections of the webinar, making it interactive with everyday life examples, questions and practical exercises
Filippo Mandolfino
GLOBAL RA SPECIALIST, Angelini Pharma s.p.a.
Oct 12 2023
Really good. The speakers did a wonderful job explaining everything.
Daphne Sotiriou
Regulatory Affairs Officer, Wockhardt UK Ltd
Oct 13 2022
Excellent presentations and course material. Always better face to face, but digital plateform worked well. All very clear. Alot was covered during two days. The case studies made me practise what we were taught.
Louisa Dew
Regulatory Affairs Consultant, NDA Regulatory Science Ltd
Apr 13 2021
Excellent webinar! [Speaker is] engaging and friendly.
Abhijit Nair
Regulatory Affairs Officer, Consilient health
Apr 13 2021
It was very interesting and informative.
Dubravka Božičević
Senior Advisor for Validation of Applications, Cratian Agency for medicinal products and medical devices - HALMED
Oct 8 2020
Excellent, clear and interactive
Mohit Pandey
Morningside Healthcare Limited
Oct 8 2020
Andrew is a good speaker and managed to keep our attention during these two days despite the fact that it was a webinar.
Chloë Braud
International Regulatory Affairs Pharmacist, Guerbet
United Kingdom
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Spain
Croatia
Czech Republic
Israel
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Poland
Sweden
Australia
Austria
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Greece
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Mauritius
Romania
Slovak Republic
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: