Mastering Pharmaceutical Packaging and Labelling Requirements in the EU

Dates in 2025 | Short Online Course

1-day live online training | Master packaging and labelling requirements in the EU – Click Here to Download the Agenda

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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.

 

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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)
What is Included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

Find out when this course is running so you can plan your training.

2025 Dates TBC

1-Day Live Online Training
Register at the top of the page.

2025 Dates TBC

1-Day Live Online Training
Register at the top of the page.

2025 Dates TBC

1-Day Live Online Training
Register at the top of the page.

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.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Complete our contact form by following the link. Get in touch.

Register Early To Save

 

Enrol before 18 October to save 20% (November Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

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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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training

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Mastering Pharmaceutical Packaging and Labelling Requirements in the EU

Dates in 2025 | Short Online Course

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