Lot 1 & lot 2 :
A Belgian representation position on the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Lot 3 : pediatrique
A Belgian representation position on the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).
A Belgian representation position on the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).role of FAMHP representative in the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The SAWP handles requests from pharmaceutical companies for scientific opinions from the EMA. These applications may cover various disciplines (quality of medicines, preclinical aspects, clinical aspects, etc.). For new requests for scientific opinions, two coordinators are appointed each time from among the members of the SAWP. These coordinators prepare a proposal for a scientific opinion with a multidisciplinary team of experts. This proposal is being discussed in the SAWP. SAWP opinions are validated by the CMHP.
A Belgian representation position on the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).role of FAMHP representative in the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The SAWP handles requests from pharmaceutical companies for scientific opinions from the EMA. These applications may cover various disciplines (quality of medicines, preclinical aspects, clinical aspects, etc.). For new requests for scientific opinions, two coordinators are appointed each time from among the members of the SAWP. These coordinators prepare a proposal for a scientific opinion with a multidisciplinary team of experts. This proposal is being discussed in the SAWP. SAWP opinions are validated by the CMHP.
A Belgian representation position on the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).This paediatric specialist will assume the role of FAMHP representative on the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).
The Paediatric Committee (PDCO) evaluates paediatric investigation plans for drugs in development. These research plans must ensure that sufficient studies are carried out for children with the developing drug, so that sufficient data is collected to be able to authorize the use of the drug in children.