Responsibility of doctors and pharmacists for the proper use of medicines covered by a risk management plan.
Currently, a risk management plan (RMP) is required for any medicinal product containing a new active substance as part of a marketing authorization application. It can also be introduced after the product has been marketed if significant changes occur (new indication, new dosage, etc.) or if a significant risk has been identified after it has been placed on the market. It is a set of activities and pharmacovigilance interventions designed to identify, characterize, prevent or minimize the risks associated with a drug once it is placed on the market. It not only helps to better characterize or prevent the risks associated with a drug but also to supplement the data available at the time of marketing and to monitor actual conditions of use.
In addition to routine activities (summary of product characteristics, public notice), RMPs imply, if necessary, measures complementary to the routine activities (Additional RMA) as restrictive conditions that may concern the prescription, delivery, distribution, use or administration of the drug (educational material and patient card in particular), as well as enhanced pharmacovigilance for some of the identified risks and post-authorization safety studies and / or use studies directly involving health professionals.
The aim of this presentation is to present in a critical and interactive way to pharmacists the roles and responsibilities of the various health professionals and patients in the practical implementation of these risk minimization activities based on concrete examples. recently discussed at European and national level. Thus, the design and implementation of educational materials for valproic acid and newer drugs will be proposed. The practical difficulties of implementing measures at the pharmacy level will be discussed as well as proposals for improvement.
Training reserved for pharmacists.
Speakers: Professor Jean-Michel Dogné
Pharmacotherapeutic News - General Training (4 credits)
Reception: 19:00
Beginning of the lecture: 7:30 pm
Good to know
https://www.flexmail.eu/f-629fda69087d5f73fd146e7c4daebc27535bf3befc0df047
Where does it take place?
SSPF
7 Rue Alcide de Gasperi
1468 Luxembourg
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