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Mastering Pharmaceutical Packaging and Labelling Requirements in the EU
16 June 2026 | 1-Day Live Online Course
Original price was: £595.£476Current price is: £476.
Master packaging and labelling requirements in the EU
Learn more about the course by toggling through the tabs below.
Course Overview
This interactive course will clarify the European regulatory requirements for developing labelling and package leaflets and clearly interpret the latest Directive. The course will also provide practical guidelines for designing and writing Patient Information Leaflets to meet regulatory requirements and satisfy readability and compliance needs. In the face of increasing regulatory and consumer demand, the need for accurate and complete product information has never been stronger. This course will provide you with key practical information on devising successful labelling strategies to guarantee complete compliance.
Key Learning Objectives
- Understand the role of the SmPC
- Learn how to create SmPCs, PILs, and labels to meet EU requirements
- Avoid common errors by reviewing examples of Patient Information Leaflets (PILs)
- Fully understand the EU regulations to ensure you have the confidence to apply them to your products
- Understand what readability means without conducting user testing
- Review the Falsified Medicines Directive to ensure and how it applies to your products.
- Understand evaluation of container labels and carton labelling, as well as ‘human factors engineering’
- Recognise the differences between the EU SmPC (e.g. being conciseness and executive) and the US PI (e.g highlight opening section, detail)
Who Should Attend?
This course has been specifically designed to address the training needs of Managers and Executives in areas such as:
- Regulatory Affairs
- Product Labeling
- Legal Counsel
- Drug Safety
- Medical Affairs
- Marketing
- Medical Information
The course will be beneficial to people new in their role, and more experienced professionals.
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
16 June 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
180 mins | 9:30 AM UK
SmPC
- Role of the SmPC
- Relationship between the SmPC and the other modules of the Marketing Authorisation
- Application
- Guidelines
- Data requirements for the different sections
Package Leaflet
- Relationship with the SmPC
- Perception of risk
- Guidelines
- Data requirements for the different sections
Labelling
- Guidelines
- Falsified Medicines Directive
- Possibility to request exemptions
Session 2
180 mins | 1:30 PM UK
Readability testing
- Why is readability testing needed?
- How is the testing performed?
- How to improve readability
Product information review during the Marketing Authorisation Application phase
- Timing of the review
- Groups involved in the review (Assessment teams, QRD,PIQ)
Post-authorisation changes to the Product Information
- Which variations affect the Product Information
- Generics/biosimilars
- Article61(3) notifications
Practical Exercise
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 managing regulatory labelling and packaging projects and has delivered multiple courses on labelling requirements.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
16 June 2026
1-Day Live Online Training
Register at the top of the page.
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.
Live Online
This course is delivered live online with direct access to the trainer.
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.
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