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17 October 2012 |
EU PAS RegisterThe European Medicines Agency (EMA) will establish and maintain an EU PAS Register for registration of non-interventional PASS, as described in GVP chapter VIII.B.4. This EU PAS Register will be an upgrade of the existing ENCePP E-Register of Studies. Before the EU PAS Register is fully operational, studies should be registered in the ENCePP E-Register of Studies to comply with GVP. Related information: - Good Pharmacovigilance Practices |
28 September 2012 |
ENCePP Plenary Meeting - 11 October 2012 Participation is open to representatives from research centres and networks that have joined ENCePP. Related information: |
21 June 2012 |
First revision of the Guide on Methodological Standards in Pharmacoepidemiology On 13 June 2012 the ENCePP Steering Group adopted the first revision of the Guide on Methodological Standards in Pharmacoepidemiology. The revised guide continues to offer a single overview document and web resource for methodological guidance for both experienced and new researchers in pharmacoepidemiology and pharmacovigilance. For each topic covered, direct electronic access is given to internationally agreed recommendations and key points from important guidelines, published articles and textbooks after an introductory review. The focus is on scientific rather than regulatory guidance although relevant legislation and good pharmacovigilance practice are cited, where appropriate. Where relevant, gaps in guidance in areas important to collaborative pharmacoepidemiology research have been addressed with what ENCePP considers good practice. The guide is specified as a reference to be consulted in the Good Pharmacovigilance Practice (GVP) modules on post-authorisation safety studies and risk management plans. For more information see: |
23 May 2012 |
Funding for medicine safety studies: European Commission Seventh Framework ProgrammeThe European Medicines Agency has published information on research activities on medicine safety that may be funded by the European Commission's Seventh Framework Programme (FP7), including background to and expected scope of proposed research opportunities for health research in 2013. Related information: » Funding for medicine safety studies: European Commission Seventh Framework Programme » ENCePP Partners Forum (ENCePP Partners only) |
11 May 2012 |
ENCePP Plenary Meeting - 3 May 2012The report of the 9th ENCePP Plenary meeting - including presentations given - has been published on this website. Related information: |
20 April 2012 |
ENCePP Plenary Meeting - 3 May 2012The next ENCePP Plenary meeting will be taking place at the premises of the European Medicines Agency on Thursday, 3 May 2012. Participation is open to representatives from research centres and networks that have joined ENCePP. Related information: |
16 April 2012 |
Notice of Call for Expressions of Interest for Drug Safety StudiesThe validity of the shortlist which was established via Call for Expressions of Interest ref. EMEA/2009/62/PHP will expire in July 2012. The European Medicines Agency (EMA) has therefore launched a new Call for Expressions of Interest with a view to drawing up a list of potential contractors who may be invited to reply to specific invitations to tender in the future. The purpose of this call is to enable the EMA to obtain fast and reliable answers to questions on safety or benefit:risk concerns, and ultimately facilitating regulatory decision-making. The scope of the funding is not restricted to research into the safety of centrally authorised products. The estimated budget per study will be between €50,000 and €130,000. Applications may be submitted anytime before 2 January 2015. The shortlist arising from this procedure will be valid until 2 April 2015. Related information: - Notice of Call for Expressions of Interest ref. EMA/2012/08/CN |
12 April 2012 |
ENCePP Steering Group 2012/2013The first meeting of the new ENCePP Steering Group took place on 21 March 2012 at the European Medicines Agency in London. During the meeting Dr Nicola Magrini of CeVEAS (Centre for the Evaluation of the Effectiveness of Health Care, Modena/Italy) was elected as Deputy Chair of the ENCePP Steering Group. Related information: |
28 February 2012 |
Good Pharmacovigilance Practice (GVP) modules released for consultationThe European Medicines Agency has released the first batch of modules on good pharmacovigilance practice (GVP) for public consultation. A total of 7 modules have been released, each covering one major process in the safety monitoring of medicines: Pharmacovigilance systems and their quality systems; Pharmacovigilance systems master files; Risk management systems; Management and reporting of adverse reactions to medicinal products; Periodic safety update reports; Post-authorisation safety studies; Signal management. The EMA would like to invite ENCePP stakeholders to comment on the practical implementation of the legislation as outlined in these modules, particularly in the GVP module for Post-authorisation safety studies. The deadline for comments is 18 April 2012. Related information: - EMA releases good pharmacovigilance practice modules for public consultation |
23 January 2012 |
ENCePP Activities 2011The ENCePP Secretariat has published a document summarising ENCePP activities in 2011. In addition to the key milestones achieved during 2011, the executive summary also includes some key metrics relating to research capacity building, as identified in the network's strategy for the impact evaluation of ENCePP. For more information see: |
18 January 2012 |
ENCePP Guide on Methodological Standards in Pharmacoepidemiology - Revision 1 ENCePP has started the first annual revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology. In order to collect comments from interested parties, a line- numbered version and a template for comments (Excel worksheet) have been made available on the ENCePP website. Comments should be sent before 31 March 2012 to encepp_comments@ema.europa.eu, preferably using the template. Related information: |
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
(link to EMA website)