The EMA Working Group is chaired by Walter Marrocco and Pieter van den Hombergh. The WG has started from a joint initiative of the Italian EFPC member FIMMG and the EFPC secretariat and was welcomed and approved by the EMA management in summer 2014. Since 27 May 2016 the EFPC is an eligible organisation of the Health Care Professional Working Party (HCPWP) and since 2019 it has become a member of the HCPWP. And in 2019 an agreement between EMA and UEMO/WONCA/EFPC was signed in order to facilitate the input of General Practitioners. It affirms EMA’s commitment to actively involve primary care professionals in its work to ensure that we can bring valuable knowledge from primary care into medicines regulation.
Since the starts, the WG has grown with a number of experts from different professional and geographical background. It now comprises more than 25 experts who can be consulted for providing specific expertise to the EMA. Please find an updated list with specialities of the different members. Recently a meeting of those experts took place at the EFPC Nanterre conference.
The EMA WG makes use of the PIE platform to facilitate discussion and exchange of information including recent expert opinions.
Interested to contact or to join? Please send a message to the EFPC secretariat.
Background
In support of the work of the EMA Health Care Professionals Working Party and its’ five main tasks:
- Support the Agency to gain a better understanding of how medicines are being used in real clinical practice and how EU regulatory decisions impact clinical practice
- How the Agency can best communicate with healthcare professionals to support their role in the safe and rational use of medicines
- Contribute to the Agency’s scientific work intended to continuously improve benefit-risk assessment of medicines throughout their life-cycle
- Enhance healthcare professionals’ organisations understanding of the mandate and work of the Agency and of the EU Regulatory Network
- Monitor the implementation of the objectives identified in the “Framework for interaction between the Agency and healthcare professionals”.
The specific focus of this network will be on task 1,2 and 4, in particular the support for safe and rational use of medicines supported by a wide range of Primary Care professionals.
Objectives
Primary objective: to create more attention among Primary Care professionals for a “rational and appropriate use of medicines at the community level”
Activities
EMA consultations
- Responses to consultations with a focus on the policy and organization of primary care in relation to medicines like the EFPC Response to the ‘Public consultation on EMA Regulatory Science to 2025’
Send a message to the EFPC secretariat if you would be willing to contribute to these consultations.
Practice
- Development of specific tools, based on EMA material, which can instruct PC professionals on the safe and rational use of medicines
- Dissemination of tools among EFPC members, particularly using the network of Community Health Centres
- Webinars through the web-based EFPC portal with postgraduate teaching courses
Policy documents
- Development of a Position Paper introducing the strength of Primary Care for achieving a safe and rational use of medicines
Meetings
A first onsite meeting took place at the EFPC 2014 Barcelona conference with the involvement of EMA. To explain the working of the EMA and to inform the group on what they could develop to be of an added value for the EMA.
With a year later a second onsite meeting of the group and a key-note of Ms Isabelle Mouton at the EFPC 2015 Amsterdam conference followed by her presence at the WONCA Europe conference in Istanbul, autumn 2015.
The report of the 19 April 2016 EMA Workshop on the collaboration with General Practitioners/Family Physicians organized by the EMA in close collaboration with the EFPC secretariat and the EMA Working Group is available at the EMA website.