Food supplements vigilance systems in a public health perspective: the European context

October 02 ^nd - 05 ^th 2022

Workshop direction: Marie Lindquist, Francesca Menniti-Ippolito, Ugo Moretti, Gwenn Vo Van Regnault

Food supplements are widely used in Europe to improve wellbeing and prevent health conditions. Food supplements regulation do not require studies on efficacy or safety before placing on the market. Although it is the responsibility of producers to ensure the safety of their products, adverse effects may occur. Indeed, they can contain pharmacologically active substances, as for example, medicinal plants, that can be associated with undesired effects. Furthermore, since they are used as self-medications, often without advise from doctors or pharmacists, it is possible that they are assumed together with prescription drugs, with the risk of interactions. Quality issues, as contamination, adulteration, higher, than allowed dosage of substances, variability among preparations can be also cause of adverse reactions . And also highly titrated extracts, multi ingredients food supplements should be object of particular caution . Spontaneous reporting systems are the only available tools to point out risks associated with these products once they are on the market and used from a large number of consumers. Some European countries have organized surveillance systems of adverse reactions to food supplements. In many countries his activity is on the way.

The purporse of the workshop is to share experiences among different European Countries to develop nd improve surveillance of adverse reactions associated with food supplement use in a public health perspective. In particular, specific goals will be:

-to present strenghts and weakness of existing systems

-to define the characteristics od an "adequate" system at the Country level

-to coordinate the activities among the different stakeholders involved in the monitoring activities

Timetable

Print timetable

Arrival of participants. All the invited persons must register in this website inserting their contact details and the details of their flights.

The transfer from the airport (Palermo or Trapani) to Erice will be organized by the Ettore Majorana Centre according to the information provided upon registration.

Dinner

09.00 Welcome and presentation of the School M. Lindquist, U Moretti

Rules of the game – how things will work/practical information, F. Menniti-Ippolito, G. Vo Van Regnault

09.30-13.00 First session (including coffee break)

Weakness and strength of the spontaneous reporting systems on food supplements

Introduction: the European context, G. Vo Van Regnault, France
Short communications on the organization of national systems (Croatia, Slovenia)
Discussion in working groups on a predefined mandate
-do we need a separate spontaneous reporting system for food supplement?
-what could be the minimum set of characteristics to have a good system at national level?
-is the coordination at European level adequate and how we can improve it?
Working groups report back
General Discussion

13.00 - 14.30 Lunch

14.30-17.30 Second session (including coffee break)

Methodological aspects of causality assessment of adverse events for food supplements

Introduction to causality assessment (Ralph Edwards)
Role of causality assessment in the surveillance of adverse events for food supplements
Short communications on the experience of national centers

Discussion in working groups on a predefined mandate

-which is the role of causality assessment in spontaneous reporting for food supplements?
-do we need a specific tool for causality in this context and how can we reduce variability?
- concerning signal detection (causality on aggregate cases) what are the key elements for a good signal detection in this context? Any difference with signal detection for other medicines?

Working groups report back
General Discussion

17.30 Thoughts and proposals for the final document

20.00 Dinner

09.00-13.00 Third Session (including coffee break)

From risk assessment to risk management in a public health perspective

The risk assessment for food supplements in Europe (F. Menniti-Ippolito and G. Vo Van Regnault)
Risk communication for food supplements

Discussion in working groups on a predefined mandate
-who has the responsibility?
-how we should communicate signal to health operators and public?
-how we can share information between countries and improve harmonization in the European context?

Working groups report back
General Discussion

13.00 - 14.00 Lunch

14.00-17.30 Fourth session (including coffee)

Final document

Proposals for the draft of the final document

20.00 Dinner

Departure of participants. The transfer to the airport (Palermo or Trapani) will be organized by the Ettore Majorana Centre.

Meeting point and time for the departure transfer will be displayed on a panel at the E. Majorana Centre in San Rocco hall, according to the information given upon registration.

Documents

Click on the name of the file to download it

Attendees

Eugenio Aiello, Italian Medicines Agency, AIFA, Italy

Elena Arzenton, University of Verona, Italy

Alessandro Assisi, Italian Medicines Agency, AIFA, Italy

Urška Blaznik, NIJZ : National Institute of Public Health, Slovenia

Jacqueline Castenmiller, NVWA : Netherlands Food and Consumer Product Safety Authority, The Netherlands

Marta Crevani, Niguarda Hospital, Milan, Italy

Dominique De Clock, Federal Public Service Health, Food chain safety and Environment, Belgium

Silvia Di Giacomo, Sapienza University, Rome, Italy

Ralph Edwards, Sweden

Silvia Emendi, Zadig Agency, Milan, Italy

Laura Augusta Gonella, University of Verona, Italy

Bruce Hugman, Communication expert, UK

Ilaria Ippoliti, ISS, Italy

Marie Lindquist, Sweden

Lara Magro, University of Verona, Italy

Gabriella Mazzanti, Sapienza University, Rome, Italy

Francesca Menniti Ippolito, ISS, Italy

Nadia Mores, Policlinico Gemelli, Rome, Italy

Ugo Moretti, University of Verona, Italy

Paola Angela Moro, Niguarda Hospital, Milan, Italy

Budimka Novakovic, Medical faculty - University of Novi Sad, Serbia

Emanuel Raschi, University of Bologna, Italy

Inese Siksna, BIOR : Institute of Food Safety, Animal Health and Environment, Latvia

Maria Rosa Valetto, Zadig Agency, Milan, Italy

Annabella Vitalone, Sapienza University, Rome Italy

Gwenn vo van Regnault, ANSES, France