Xtalks eCademy: GCP Training: How to Survive a European Medicines Agency (EMA) Audit

GCP Training: How to Survive a European Medicines Agency (EMA) Audit

In recent years, the increasingly global nature of health research, and in particular the conduct of clinical trials involving human participants, has highlighted a number of ethical issues, especially in those situations wherein researchers or research sponsors from one country wish to conduct research in another country.

For those interested in doing clinical research in the European Union (EU), did you know that under the new ICH GCP E6 guidelines a sponsor will be able to submit a single clinical trial application that covers all EU countries involved in the clinical trial? Or that a sponsor may transfer any or all of the sponsor's clinical trial-related duties and functions to a clinical research organization (CRO), with the sponsor ultimately responsible for the quality and integrity of the clinical trial data?

If you’re thinking about participating in the European clinical trial market are you confident you understand the intricacies of the new regulations? Do you have the appropriate processes in place to ensure you are audit ready? This GCP training will prepare clinical research sites, pharmaceutical sponsors and clinical research organizations in the field of international clinical trial management, through a detailed review of the complex regulations of the European Medicines Agency. We will discuss the pitfalls that you may experience in an EMA audit and how best to avoid them.

Are you and your team prepared to enter the European market? Join this GCP training course to find out and get prepared. Only a limited number of registration seats are available.