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Information for citizens
Information for medical specialists
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Information for medical specialists

Practice run on public hearings

EMA conducted an internal practice exercise (dry run) in order to test the process and procedures for public hearings. Using a fictional scenario of a safety review, the PRAC experienced how such a hearing would take place. This has enabled EMA to ensure all practical arrangements needed for these hearings are in place and PRAC members to test this new form of interaction. Following this successful simulation, the PRAC is ready to incorporate public hearings as part of its core activities.

Public hearings are a new tool for EMA to engage European Union (EU) citizens in the regulation of medicines and to listen to their views and experiences. The pharmacovigilance legislation has given the PRAC the possibility to hold public hearings as part of certain safety reviews of medicines. Contributions made by the public during these hearings will be considered by the PRAC and inform the Committee’s decision-making.

Public hearings will be held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review. The first public hearing could take place as early as the fourth quarter of 2016, as soon as a relevant topic is identified.

More information is available on our 'public hearings' webpage as well as in the rules of procedure for these hearings.

 
Information for medical specialists

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig (idelalisib), confirming that the medicine’s benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukaemia (CLL) and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia and has updated recommendations to manage this risk issued at the beginning of the review.

More information on:

PRAC concludes review of Zydelig and issues updated recommendations for use

 
Information for medical specialists

EMA to review modified-release paracetamol

Measures to minimise risk and reduce harm of overdose to be considered

More information on this is included in the hyperlink below:

Paracetamol-modified release

 
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