15 December 2016 EMA/705066/2016 Stakeholders and Communication Division
Revised framework of interaction between EMA and healthcare professionals and their organisations Annex I – Action plan Estimated
Actions
timeframes for completion •
Continue the mapping of relevant organisations and update information in
On-going
the EMA’s stakeholders database •
Maintain the network of European healthcare professionals’ organisations
On-going
•
Agree on working methods for the EMA Healthcare Professionals Working
Q2 2017
Party intended to: −
Reinforce interaction with patients, academia and the EMA human scientific committees and working parties
−
Refine efforts in the domain of information on medicines to healthcare professionals
−
Share best practices on how healthcare professionals’ organisations are creating awareness and understanding of EMA’s mandate and work
•
Establish and maintain pools of experts as needed: −
Maintain and expand the pool of experts on medication errors – continue
On-going
to identify healthcare professionals (doctors, pharmacists, nurses) with relevant expertise who can make timely contributions to EMA scientific committees, working parties, scientific advisory groups, etc. −
Maintain and further activate the pool of general practitioners/family
Q4 2017
physicians – identify concrete areas to pilot involvement and based on the outcome of the pilot phase develop a multi-annual action plan
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5545 Send a question via our website www.ema.europa.eu/contact
Promote participation at key milestones during the lifecycle of medicines: −
Review process to bring healthcare professionals’ input into EMA
Q2 2018
scientific advice and qualification of novel methodologies for medicine development −
Increase specific dialogue and interaction with healthcare professionals’ organisations on development and implementation of risk management
Q4 2017
plans −
Continue to identify suitable experts who can timely contribute to EMA benefit-risk assessment procedures
−
On going
Consider the evolving roles of nurse practitioners/ nursing specialists and explore where nurses’ input into EMA activities would be of mutual
Q2 2018
benefit •
Develop specific dialogue and interaction with healthcare professionals’
Q4 2018
organisations on: −
early access to medicines (i.e. use of real-world data and patient registries)
− −
support to innovation (i.e. personalised medicine) EMA guideline development process (blending science, clinical practice and regulation)
•
Stimulate reciprocal transfer of knowledge between healthcare professional organisations and EMA −
Identify existing practices (e.g. jointly organised events; involvement in training programmes)
− •
Discuss best practices and share learnings
Monitor and increase transparency on the involvement of healthcare
Q4 2017 Q4 2018 On going
professionals and their organisations in the Agency’s activities: −
Establish a system for regular cross-Agency collection of quantitative and qualitative data for monitoring and reporting purposes
−
Acknowledge and promote visibility of input provided by healthcare professionals and their organisations in the context of the activities of scientific committees, working parties, scientific advisory groups and other expert groups
Revised framework for interaction between the European Medicines ...
Dec 15, 2016 - and explore where nurses' input into EMA activities would be of ... support to innovation (i.e. personalised medicine) ... training programmes).
Dec 15, 2016 - Refine efforts in the domain of information on medicines to ... Share best practices on how healthcare professionals' organisations are creating ...
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Jun 15, 2017 - training tools and materials and developing new ones ..... which is responsible for the assessment and monitoring of human ...... Alert Card).
Jun 16, 2016 - Send a question via our website www.ema.europa.eu/contact ... associations of professionals or service providers operating in or supporting ... A multi-stakeholder workshop on Orphan Medicines was hosted by EMA at year end. ..... from
Jun 15, 2017 - 10th anniversary of Patients' and Consumers' Working Party . ... 13. 1.8.2. Social media workshop . ... Information on EMA website . ...... âThe PCWP in its ten years of existence has been a catalyst for a profound culture.
the EU have access to high-quality, effective and safe medicines. The centralised ... Pharmaceutical companies submit a single authorisation application to EMA. .... guide the development programmes of all medicine developers who wish to ...
Dec 14, 2017 - rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002, OJ L. 298, 26.10.2012, p. 1. 10 Article 1(2) of .... revision takes into account the lessons learnt in the course of the i
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authorisation application to EMA. Each new medicine is ... EMA encourages research and development of new ... in the EU, we have access to the best scientific.
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The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
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For a list of RSS readers please refer to our RSS guide and follow the instructions .... WEB-RADR workshop report: mobile technologies and social media as.
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PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
