It operates under the Haematology Working Party (HWP) and Committee for Medicinal Products for Human Use (CHMP).

The Heamatology ESEC provides a platform for information-sharing about:

  • emerging regulatory actions and guidelines from the European Medicines Agency's (EMA) scientific committees;
  • completed assessments of product-related procedures and guidelines;
  • ongoing EU activities in the field of haematology (non-malignant);
  • international regulators’ input;
  • important scientific developments outside the European medicines regulatory network, such as new treatment guidelines.

The Haematology ESEC's tasks include:

  • mapping competences across the European network of experts;
  • providing training and up-skilling to the European medicines regulatory network;
  • connecting experts from multidisciplinary teams and across topics of expertise.

The ESEC as a group does not contribute to any regulatory procedures or actions related to product-related activities and guidelines. This means it does not give advice or take decisions.

Individual ESEC experts can contribute to EMA’s scientific work as members of scientific committees, working parties or drafting groups.

Mandate, rules of procedure and work programme

The Haematology ESEC's mandate is available below:

Mandate, objectives and rules of procedure for the Haematology European Specialised Expert Communities (ESEC)

Reference Number: EMA/CHMP/BPWP/90503/2023

English (EN) (194.81 KB - PDF)

First published:
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For details on the work programme for the Haematology ESEC, refer to the Haematology Working Party.

Composition

The Haematology ESEC is composed of European experts selected according to their specific expertise in haematology and related disciplines. Members are nominated by the CHMP.

All members have signed a public declaration of interests and confidentiality undertaking form.

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