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RSSThe European Medicines Agency (EMA) is preparing guidance in the form of “Questions and Answers” on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.
A new ICH-E19 draft guideline on the optimisation of safety data collection in interventional clinical trials and non-interventional studies has been published by ICH for public consultation.
The 1,500th study was registered in the EU PAS Register (study EUPAS29415) in April 2019. By facilitating the review of protocols and results, the EU PAS Register is also increasingly used for academic research.
The meeting report and presentations from the ENCePP webinar (organised by Agenzia Regionale di sanità Toscana) have been published.
For more than 10 years EMA has been at the forefront of scientific independence and transparency in real world data studies through ENCePP.
The ENCePP Secretariat has published a summary of the network's activities in 2018.
The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018.
The EMA cross-committee task force on registries has published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes.
The ENCePP WG1 has finalised Revision 4 of the ENCePP Checklist for Study Protocols and it is now published on ENCePP website.
The 7th revision of the ENCePP Methods Guide is now available on the ENCePP website. This latest version includes some significant revisions, amendments and new references in all the chapters.
Since 2010, the ENCePP Code of Conduct provides a set of principles and recommendations to promote scientific independence and transparency of observational research, especially where they may be threatened by the influence of study funders.
An article reviewing ENCePP’s main achievements over the past ten years, discussing its impact on the benefit-risk evaluation of medicinal products in Europe and outlining future perspectives has been published online in Pharmacoepidemiology and Drug Safety (open access).
Abstracts for the 34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (2018 ICPE) are now being accepted online. Deadline for submission is 14 February 2018.
The European Medicines Agency has launched an open call for tender with the aim of establishing a number of framework contracts with research organisations for efficacy and safety studies on medicines to generate data and information to support regulatory decision-making(...)
The 16th ENCePP plenary meeting will be taking place at the premises of the European Medicines Agency in London on Tuesday, 21 November 2017.
The International Society of Pharmacovigilance (ISoP) annual meeting is taking place in Liverpool during October (16th-18th).
A new infosheet on ENCePP has been published to coincide with the 10 year anniversary of the network.
The European Union Intellectual Property Office (EUIPO) has approved the registration of ‘EU PAS Register’ as a European Union trade mark.
The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website. This latest version includes revisions, amendments and new references in all the chapters.
The ENCePP Steering Group has adopted the network's new three year work plan. The main goal during 2017 to 2019 will be to optimise ENCePP's input to regulatory decision-making throughout the product life-cycle.