Scientific Advisory Group

A scientific advisory group refers to a collective of European experts who are assembled with the purpose of providing guidance and advice in relation to the evaluation of specific medicines. These groups are typically established to offer specialized knowledge and insights in their respective fields of expertise, ensuring a comprehensive and well-informed evaluation process.

Scientific advisory groups are often formed by regulatory authorities, such as the European Medicines Agency (EMA) in the European Union, to enhance the evaluation and decision-making processes regarding medicines. The composition of these groups usually includes scientists, clinicians, researchers, and other professionals with extensive experience and expertise in relevant disciplines, such as pharmacology, toxicology, clinical trials, and specific therapeutic areas.

The primary role of a scientific advisory group is to assess and evaluate data and information related to specific medicines under review. They carefully examine scientific evidence, clinical trial results, safety profiles, and other relevant data to provide objective and evidence-based advice to regulatory authorities. This advice is crucial for regulatory decision-making, including the authorization, labeling, and post-marketing surveillance of medicines.

Scientific advisory groups contribute to the transparency and robustness of the evaluation process by providing independent and expert opinions. Their assessments help ensure that regulatory decisions are based on the best available scientific knowledge and take into account factors such as efficacy, safety, quality, and risk-benefit profiles of the medicines under consideration.