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3 reviews for
Regulatory Lifecycle Management in The EU (Filing Variations)
28 April 2026 | 1-Day Live Online Course
Original price was: £595.£476Current price is: £476.
Develop effective regulatory strategies for filing variations and line extensiosn in the EU
Learn more about the course by toggling through the tabs below.
Course Overview
Filing variations are a major component of regulatory lifecycle management. It is important to optimise your procedures for faster, streamlined and compliant variation submissions. Regulators want to see successful variations of strategies across regulatory teams. It is therefore important for you to understand the regulations, definitions and best practices for implementation.
This training course will provide you with a complete overview of the EU regulations when filing a variation to marketing authorisation. You examine the various types of variation and learn how to optimise your procedures for streamlined variation submissions. You will also examine grouping and work-sharing so you know when to apply it to your variations.
The European Commission (EC) has recently published a draft version of the EC guidelines on the details of the various categories of variations and operation of the procedures. It is expected that these guidelines will apply from 15 January 2026, and the course will provide an in-depth overview of the changes.
Key Learning Objectives
- Gain a comprehensive overview of the EU Regulations for filing variations to ensure compliance
- Develop a filing variation strategy to streamline your processes
- Examine grouping and work-sharing to understand when they can used
- Review specific variation cases such as changes to module 3 and new clinical data
- Understand the variations process through centralised, mutual recognition and decentralised procedures
- Review the impact of the latest proposed amendments to the European Commission guidelines on variations categories and procedures
Who Should Attend?
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
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
28 April 2026 | 29 September 2026
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.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
28 April 2026
1-Day Live Online Training
Register at the top of the page.
29 September 2026
1-Day Live Online Training
Register at the top of the page.
On-Demand Access
Can’t wait for the next course date?
Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
Course Times
For live online delivery, the course starts at 9:30 AM (UK time) and finishes at 4:30 PM (UK time).
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to two weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
6 Hours of Learning
This course includes a total of 6 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
3 reviews for Regulatory Lifecycle Management in The EU (Filing Variations)
28 April 2026 | 1-Day Live Online Course
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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.