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
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.
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
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
-which is the role of causality assessment in spontaneous reporting for food
-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?
17.30 Thoughts and proposals for the final document
09.00-13.00 Third Session (including coffee break)
From risk assessment to risk management in a public health perspective
13.00 - 14.00 Lunch
14.00-17.30 Fourth session (including coffee)
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.
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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 ItalyGwenn vo van Regnault, ANSES, France