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Mastering Pharmaceutical Packaging and Labelling Requirements in the EU
Dates in 2025 | Register Your Interest
1-day live online training | Master packaging and labelling requirements 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 (trainer, agenda, 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
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.
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.
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Enrol before 18 October to save 20% (November Course)
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Download the Agenda
You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.
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