The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used to treat or prevent infections help medicine developers prepare marketing authorisation applications.

HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines

The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.

HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines

The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the...

HumanRegulatory and procedural guidancePharmacovigilanceResearch and development