REGULATORY REQUIREMENTS FOR CLINICAL TRIALS is a course that covers topics such as:
- Clinical Trial Directive process
- Clinical trial regulations and guidelines in Europe
- Clinical Trials Authorisations: Ethical Approval and Regulatory Approval
- EU Clinical Trial Directive and GCP Directive
- Clinical Trial Data Management
- Pharmacovigilance & Adverse Event Reporting
- Proposed Changes to the Clinical Trial Directive Requirements
REGULATORY REQUIREMENTS FOR CLINICAL TRIALS brings together biotechnology CRO and SMO companies, Clinical research professionals in pharmaceutical, departments such as clinical trial supply, study sites including investigator initiated studies, document management, regulatory affairs, regulatory authorities and legal, drug safety quality assurance, other professionals interested in regulations and guidelines covering clinical trials.
