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3 reviews for
Regulatory Lifecycle Management in The EU (Filing Variations)
13 May 2025 | Short Online Course
Original price was: £595.00.£476.00Current price is: £476.00.
1-day live online training |Â Develop effective regulatory strategies for filing variations in the EU – Click Here to Download the Agenda
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)
Course Information
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
13 May 2025 and 7 October 2025
1-Day Live Online Training
Register at the top of the page.
Session 1
180 mins | 9:30 AM UK
Overview of the different types of variations and the different procedures for a Marketing Authorisation in the EU
- Four different authorization procedures
- Different kinds of variations
- Commission Regulation 1234/2008, Commission Regulation 712/2012 and others
Variations Type IA and Type IAIN
- Grouping
- Submission
- Review
Variations Type IB
- Grouping
- Submission
- Review
Variations Type II
- Grouping
- Submission
- Review
Session 2
180 mins | 1:30 PM UK
Variations involving Product Information
- Role of the SmPC
- Guidelines
- Referrals
CMD(h) recommendations on unclassified variations
- Where to find the information
- Examples
Line extensions
- Submission
- Timelines
- Examples
Work-sharing between the regulatory authorities
- What is work-sharing?
- Which variations are suitable for work-sharing?
- Timelines
Other procedures
- PSURs
- Renewals and annual reassessments
Practical Session
- Common mistakes
- Classify variations according to the guidelines
Examine the latest proposed amendments to the European Commission guidelines on variations categories and procedures
- Whats is new
- How will this impact variations in the future
Adriaan Fruijtier graduated as a pharmacist at the University of Utrecht, The Netherlands. Since April 2004 he has been an independent regulatory affairs consultant. Until March 2004 he was Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands and has worked as Manager of Regulatory Affairs at Glaxo, also in the Netherlands.
Adriaan has extensive experience implementing filing variations throughout his career and provides regular training on the topic.
This course is aimed at professionals who are involved in the regulatory lifecycle management of their marketing authorisations. These include
- Regulatory Affairs Professionals
- CMC Regulatory Professionals
- Compliance Personnel
- Project Managers in Regulatory Affairs
- Dossier Registration Professionals
- Documentation Specialists
Educo Life Sciences –
This is a new course – Reviews will be added after the first delivery!
Bosnalijek (verified owner) –
The course about Filling Variations expanded my knowledge about the variation application procedure, the classification method and the time of application of type IA variations, the time of approval by the Agency, the deadlines for responding to clock stop in the EU. The line extensions is explained in particular detail, using practical examples. In addition, the work-sharing procedure was clarified, which will be useful for me and useful in future work.
Norgine (verified owner) –
I just recently enrolled in a Regulatory Affairs role and my RA is not very solid; nevertheless, I was able to follow easily the lecture provided by the trainer, who was very clear and competent; the material shared during the lesson was very well prepared and detailed and it is a very helpful resource also to look at for future reference. Great course and absolutely great trainer.