Understanding the European Legislation & Implementing the Guidelines 2014 is a course that covers topics such as:
- Clinical trial authorization from ethics committees and authorities
- Review of key areas of the directives and implementing texts
- Safety reporting & GCP inspections
- Update on current guidance documents, Trial Master File and archiving
- Upcoming regulations and developments
Understanding the European Legislation & Implementing the Guidelines 2014 is intended for:
- Contract Research Organisations (CROs)
- Pharmaceutical companies
- Site personnel and ethics committee members
- Investigators
- Regulatory affairs and pharmacovigilance departments within the pharmaceutical industry
- People from clinical research
