Hot Topic: Product Information – Opportunities, Challenges and Link to the European Commission Assessment

One day hot topic seminar

  • TBD

1 day course


3.750,- DKK ex VAT
(app. 504,- EUR ex VAT)

At the moment there is no available dates for this course.


In the Pharmacovigilance Directive 2010/84/EC, Article 59, the European Commission was required by 1st January 2013 to present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL) and how they could be improved in order to better meet the needs of patients and healthcare professionals.

The European Commission shall, if appropriate, and on the basis of the report, and consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents.

On 12th November 2012 Medicademy (now Atrium) held a hot topic seminar on product information (PI). From this seminar a clear message emerged: the current PI for medicinal products is a dinosaur, i.e. endless, foldable add on PI content. A drastic change in thinking and practice is needed to make sure the information meets the needs of the stakeholders, not least the patients. Several good ideas were already under development. By 22nd March 2017 the European Commission released its long waited final assessment report including areas to be improved within current legislation.

This hot topic seminar on EU PI will cover:

  • What are the identified short- and long-term comings of the European Commission report and what are their recommendations?
  • What are the next steps for the European Commission?
  • What are the next steps for the European Medicines Agency (EMA) as well as for the European Union (EU) Human Coordination group for the Mutual Recognition and the Decentralized Procedures (CMDh)?
  • What is the opinion of the EU patients as well as the EU Health Care Professionals (HCPs)?
  • What is the opinion of the EU pharmacies?
  • What is the opinion of the Pharmaceutical Industry?
  • What is the national experience of electronic dissemination of latest versions of PI seen from regulators and industry perspectives?
  • Why should PI be seen as a very important part in the wider context of Health Literacy?
  • Can medication errors be reduced through the PL?
  • What are the recent trends and can we predict the future?

After this hot topic seminar, you will have obtained an overview of the current gaps of the PI legislation and guidelines, EU framework and ongoing proposals for future work to close those gaps. This work will mainly be through a mutual collaboration between the European Commission, the EU regulators, the patients, the HCPs, the pharmacies and the industry.


Product Information
The European Commission
Assessment Report
European Medicines Agency

What you will learn

  1. The current gaps of the PI legislation, guidelines and EU framework and the ongoing proposals for future work to close the gaps
  2. The identified short term and long term comings of the European Commission report and the recommendations
  3. The different stakeholders’ – patients, healthcare professionals, pharmacists and the industry’s view of the European Commission Report
  4. How product information can contribute to health literacy
  5. How to reduce medication errors through the package leaflet (PL)
  6. The next steps, recent trends and future predictions

What your company will get

  1. A professional who understands the EU PI legislation, -guidelines and -framework
  2. A professional who can provide valuable input to all other team members regarding EU Product Information
  3. A professional who can play an important role in any project team providing strategic advice on and take part of strategic discussions and decisions on EU Product Information

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.


Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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