Environmental Risk Assessment European Specialised Expert Community
Human
Veterinary
The European Medicines Agency's (EMA) Environmental Risk Assessment European Specialised Expert Community (ERA ESEC) is a platform for information-sharing and interactions between experts in the environmental risk assessment field.
The ERA ESEC operates under the Environmental Risk Assessment Working Party (ERAWP) and Non-clinical Working Party (NCWP), and is overseen by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP).
Role
The ERA ESEC provides a platform for:
- connecting experts from multidisciplinary teams and across topics of expertise.
- knowledge transfer and communication related to ERA to facilitate the implementation and application of the regulatory framework for veterinary and human medicinal products.
- providing training to the European medicines regulatory network;
- supporting the delivery of relevant activities of the ERAWP and NcWP workplans.
The specialised expert community does not contribute to any regulatory procedures or actions related to product-related scientific evaluations or scientific guidelines. It does not give advice or take decisions. Individual members may contribute to EMA’s scientific work as members of scientific committees, working parties or drafting groups.
Mandate, objective and rules of procedure
The specialised expert community's mandate is available below:
Composition
The ERA ESEC is composed of European experts with a special interest or expertise in the area of environmental risk assessment. They are selected from within the European medicines regulatory network and academia (e.g. research institutions or universities).
Members are nominated by a committee member/alternate. Membership is endorsed by CHMP and CVMP.
All members have signed a public declaration of interests and confidentiality undertaking form.