New ENCePP Steering Group, 2021-2023

The composition of the new ENCePP Steering Group for 2021-2023 has been published on the ENCePP Steering Group page. The ENCePP SG includes representatives from ENCePP partners, the EMA, EMA Scientific Committees and learned societies (International Society of Pharmacovigilance (ISoP), International Society for Pharmacoepidemiology (ISPE), International Society for Pharmacoeconomics and Outcomes Research (ISPOR)), and observers from the Food and Drug Administration (FDA), Health Canada and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The co-chairs of the Steering Group will be announced after the first SG meeting in January 2021.

Related information: Composition of new ENCePP Steering Group

Report of the “ENCePP in the Time of Covid” meeting published

The report and the presentations of the virtual ENCePP webinar held on 20 November 2020 have been published on the ENCePP website. The meeting outputs will feed into the revision of the ENCePP mandate, which will aim to address the need for high-quality evidence supporting Covid-19 related regulatory decisions and to successfully integrate the network into the new research environment that will prevail from 2021, including DARWIN EU and other European efforts around AI and digital data capture. 

Related information: Meeting report and presentations

5 November

2020

“ENCePP in the Time of Covid” virtual webinar for ENCePP Partners, 20 November 2020

The ENCePP webinar will discuss new challenges to be addressed by the ENCePP network and establish the new ENCePP Steering Group.

Objectives of the meeting:

• To discuss methodological considerations for observational studies on Covid-19 and how ENCePP could promote best practice, especially for the monitoring of Covid-19 vaccines safety and effectiveness.

• To present the recommendations of the HMA-EMA Big Data Task Force and the proposed Data Analysis and Real-World Interrogation Network in the European Union (DARWIN EU), and discuss the interface between ENCePP and the Task Force.

• To summarise the achievements of the current ENCePP Steering Group, introduce the members of the new ENCePP SG and discuss proposals for a draft ENCePP mandate.

The webinar is open only to ENCePP Partners (centres and networks), who have expressed their interest via the registration form by 11 November (extended deadline).

Related information: Agenda

Virtual workshop on the draft guideline on registry-based studies

A workshop on the draft guideline on registry-based studies scheduled for Monday, 19 October 2020 from 12:30-17:00 (CET) has been announced on the EMA website.

This half-day virtual workshop will give an overview of the Guideline that will be published for consultation at the end of September 2020, and will provide the opportunity for stakeholders to ask questions for clarification.

The meeting will be broadcast live on EMA’s website. In addition, there will be a limited capacity to participate in the virtual room for people who wish to make verbal contributions to the meeting. Interest in joining the virtual room can be expressed by completing the online form by 9 October 2020. After this deadline, the EMA will review the requests received and will select the participants to ensure a fair representation of the different stakeholders.

Related information:

» Workshop agenda

» Expression of interest form

Contact point: EMAregistries@ema.europa.eu

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.

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

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)

EU PAS Register® technical upgrade with new functionalities

The European Union electronic Register of Post-Authorisation Studies (EU PAS Register^®) is the publicly available register of non-interventional post-authorisation studies (PAS) maintained by the European Medicines Agency. With the latest technical upgrade important functionalities have been added to meet our stakeholders’ business demands and to further increase transparency on non-interventional research for medicines authorised in the European Union. The January 2020 upgrade includes a number of new functionalities based on the feed-back received from stakeholders:

With this upgrade further functionalities have been added to facilitate administrative tasks performed by the Agency.

The EU PAS Register continues to gain importance as is a unique source of information on the safety and effectiveness of authorised medicines. By the end of 2019 a total of 1,674 studies have been registered which represents an increase of about 20% over the previous year.

Related information:

»  EU PAS Register^®