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ENCePP News Archive 2012




17 October 2012
EU PAS Register

The 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:

- EU PAS Register

- Good Pharmacovigilance Practices (link to EMA website)

28 September 2012

ENCePP Plenary Meeting - 11 October 2012
The 10th ENCePP Plenary meeting will be taking place at the premises of the European Medicines Agency on Thursday, 11 October 2012.

Participation is open to representatives from research centres and networks that have joined ENCePP.

Related information:

- Draft Agenda, ENCePP Plenary meeting 11/10/2012

- ENCePP Plenary Rules of Procedure and Mandate

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:

- Standards & Guidances

23 May 2012
Funding for medicine safety studies: European Commission Seventh Framework Programme

The 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:

» European Medicines Agency publishes supplementary information on funding for medicine safety studies through Seventh Framework Programme

» Funding for medicine safety studies: European Commission Seventh Framework Programme

» ENCePP Partners Forum (ENCePP Partners only)

11 May 2012
ENCePP Plenary Meeting - 3 May 2012

The report of the 9th ENCePP Plenary meeting - including presentations given - has been published on this website.

Related information:

- ENCePP Plenary meeting reports

20 April 2012
ENCePP Plenary Meeting - 3 May 2012

The 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:

- Draft Agenda - ENCePP Plenary Meeting 3 May 2012

- ENCePP Plenary Rules of Procedure and Mandate

16 April 2012
Notice of Call for Expressions of Interest for Drug Safety Studies

The 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 2012/2013

The 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:

- ENCePP Steering Group

- Minutes of the ENCePP Steering Group Meeting 21/03/2012

28 February 2012
Good Pharmacovigilance Practice (GVP) modules released for consultation

The 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 2011

The 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:

- Report on ENCePP Activities in 2011

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:

- ENCePP Standards & Guidances

 

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