57
edition nº
The Portuguese offer to host EMA
headquarters is now concluded
The last meeting from the National Candidacy Comission, which is working on the portuguese bid to host the European Medicines Agency (EMA), took place on the 26 the july.
The Commission concluded the offer from Porto in time to be sent to Brussels until july 31. A hard and solid work from an interministerial team, with elements from the Foreign Affairs Ministry, as well as experts from the Health, Education, Economics or Finance, made it possible.
The partnership from the Infarmed, responsible for the operational coordination and technical support, organizing the requires information, was also crucial at the the first phase of this bid to host the EMA headquarters.
European Agency of Medicine reviews
The guidelines for clinical trials
The European Medicines Agency (EMA) published a revised guideline on first–in-human clinical trials, to help the stakeholders identify and mitigate risks for participants.
On the trials first phase, which marks the transition from in vitro or animal research to testing in humans, there are major risks involving healthy individuals who participate in the trials. However, only on rare occasions the participants suffered serious harm.
As safety is a priority on a clinical trial, this guideline puts emphasis on the sponsor’s need to the define the degree of uncertainty linked to each tested medicine, as well as the measures to be implemented when these reactions are identified or in case of an event of potential risk.
This reviews takes the experience and the increasing complexity in clinical trials over the last decade into account.
In september, the EMA will make all the comments regarding the guidelines available. The final document shall enter into force on the 1st february 2018.
Project in the approval phase
Aims to adjust shifts of pharmacies
The government is working on a legal document to adjust the regime that regulates the shifts and the number of pharmacies in permanent service and availability. A draft amendment is already being analysed, ensuring no concerns related to access and pharmaceutical services availability per inhabitant.
The aim is to ensure that the shifts system is adapted to reality, allowing the 24 hour open pharmacies to be considered, in a certain distance and in the neighbouring municipality. This amendment is complemented with a new regime of complementarity shifts. The main goal is to respect the demographic and geographic specificities. No change will be executed without the municipalities agreement.
Eudravigilance course will take place
in Infarmed between 8 and 10 November
A training course about the new european system of pharmacovigilance (EudraVigilance) will be held at the Infarmed, between 8 and 10 november. The system has new features for the reporting and analysis of suspected adverse reactions, changes that will be addressed in this 3-day event.
The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: Hands-on Training Course has limited places, so it is highly recommended that the registrations take place as soon as possible. The program and the registration form are available on the website of the INFARMED.
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Parque de Saúde de Lisboa - Avenida do Brasil, 53, 1749-004 Lisboa - Portugal
Telef: +351 217 987 100 | Fax: +351 217 987 316 | E-mail: Infarmed@Infarmed.pt