Scientific Advice Working Party

The Scientific Advice Working Party (SAWP) is a standing working party with the sole remit of providing scientific advice and protocol assistance. It was established by the Committee for Medicinal Products for Human Use (CHMP).

The SAWP is a multidisciplinary group, which comprises a chairperson, 28 members including three members of the Committee for Orphan Medicinal Products (COMP), one member of the Paediatric Committee (PDCO) and one member of the Committee for Advanced Therapies (CAT).

In the nomination process of the working party's members, a fair representation of the following areas of expertise is ensured:

• non-clinical safety;
• pharmacokinetics;
• methodology and statistics;
• therapeutic fields for which there are frequent requests or which are defined in the Annex of Regulation (EC) No 726/2004, such as cardiology, oncology, diabetes, neurodegenerative disorders and infectious diseases including human immunodeficiency virus (HIV) infection.

The SAWP co-ordinates the provision of scientific advice and protocol assistance. It brings an integrated view forward to the CHMP and the COMP on:

• quality relating to the development of medicinal products;
• non-clinical and clinical safety and efficacy relating to the development of medicinal products;
• the significant benefit of orphan medicinal products.

The SAWP meets 11 times a year at the European Medicines Agency for a three-to-four-day meeting, generally two weeks before the monthly CHMP plenary meeting:

• SAWP meeting dates and submission deadlines for 2011;
• SAWP meeting dates and submission deadlines for 2012.

Mandate, rules of procedure and work programme

More information on the SAWP's responsibilities and composition is available in this document:

• Mandate, objectives and rules of procedure

Members

Below (in alphabetical order of surname) are the current members of the SAWP. The members' declarations of interests are available in the European expert list.