Emer Cooke Appointed Executive Director of European Medicines Agency
What happened
Emer Cooke was appointed as the executive director of the European Medicines Agency (EMA). The EMA is the highest regulatory authority on medicines in the European Union and is currently seeking feedback on requirements for clinical trials of drugs treating systemic sclerosis (SSc).
From raps.org
Why it matters
The EMA provides scientific opinions and recommendations that the European Commission uses to issue final market authorization decisions for drugs in the EU. The agency's work involves weighing in on debates regarding whether sponsors should conduct one or two pivotal trials, emphasizing that the decision must be based on the evidence needed to show a positive benefit-risk balance.
From raps.org
Who's involved
- European Medicines AgencyHighest regulatory authority on medicines in the European Union
- Emer CookeResearcher appointed as the executive director of the EMA
- Eli Lilly and CompanyAmerican pharmaceutical company relying on EMA guidance
- Novo NordiskDanish pharmaceutical company relying on EMA for market authorization
- FDACoordinating body with the EMA on global drug approval standards
- European CommissionExecutive branch of the European Union that reviews EMA recommendations
Keep exploring
The entities involved
-
European Medicines Agency
highest regulatory authority on medicines in the European Union