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About ENCePP

Find out more about the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

 

Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Find out more

Do you wish to register a study in the EU PAS Register?

Find out more

Are you considering applying for an ENCePP study seal?

Read a personal account of the ENCePP study approval process

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

 

 

 

Latest News
27 May 2020

EMA calls for high-quality observational research in context of COVID-19

 

The EMA published a press release on 26 May 2020, calling for for high-quality observational research in the context of COVID-19. The text emphasises that when planning observational studies, researchers should adhere to existing guidelines on the appropriate design and conduct of pharmacoepidemiological studies in order to generate reliable and reproduceable evidence, including the ENCePP Guide on methodological standards in pharmacoepidemiology. EMA also reminds researchers to post all protocols and reports of observational COVID-19 studies in the EU PAS register to ensure transparency and scrutiny of study design and results. This text refers to the ENCePP COVID-19 Response Group promoting use and dissemination of valid and reliable methodologies appropriate to COVID-19.

 

25 May 2020

Mandate for ENCePP support to COVID-19 activities

 

On 18 May 2020, the ENCePP Steering Group endorsed a mandate for ENCePP activities in relation to the COVID-19 pandemic. It includes to facilitate access to high quality data and their analysis to support research and regulatory decisions in relation to the COVID-19 pandemic, to support collaborations aiming to design and conduct high quality multicentre observational research, and to improve regulatory science by promoting use and dissemination of valid and reliable methodologies appropriate to COVID-19.

 

Related information:

»  ENCePP COVID-19 Response Group mandate

 

12 May 2020

Discussion paper on the general data protection regulation: secondary use of data for medicines and public health purposes

 

The 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.
Therefore, EMA would like to gather input from patients, consumers and healthcare professionals as data contributors as well as from medicines developers, research-performing and research-supporting infrastructures and other data providers (e.g. payers of healthcare).
In the context of the General Data Protection Regulation (EU) 2016/679 (GDPR) and focusing on nine key topics outlined in the below discussion paper, EMA would appreciate to receive feedback on specific data protection questions on secondary data use.

 

The contributions can be sent by 10 July 2020 to the following functional mailbox: dpconsultation@ema.europa.eu

 

Related information:

»  Discussion paper

»  EMA Big Data webpage (Section: data protection)

 

26 March 2020

Registration of COVID-19 related studies in the EU PAS Register

 

In these exceptional circumstances, many research groups in Europe and around the world have started or are planning observational studies related to the utilisation and effects of drugs in relation to the Covid-19 pandemic.

In order to support the sharing of information on performed or planned studies and increase the efficiency of research, ENCePP and EMA strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register.

Researchers are also encouraged to upload and make public the study protocol with a description of the data collected or planned to be collected in order to facilitate and speed-up the design of observational studies by others.

In order to facilitate the retrieval of studies related to the Covid-19 pandemic, investigators should  include the term “COVID-19” in the study title. Using this term in the field “Title of Study” of the search function will allow retrieval of all registered studies related to the pandemic.

 

Attention is drawn to the following recommendation issued by the International Committee of Medical Journal Editors (ICMJE): In the event of a public health emergency (as defined by public health officials), information with immediate implications for public health should be disseminated without concern that this will preclude subsequent consideration for publication in a journal. We encourage editors to give priority to authors who have made crucial data publicly available (e.g., in a gene bank) without delay.

 

Related information:

»  EU PAS Register®

 

 

 

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