This three-day course is designed for those who perform, supervise, manage, audit, or oversee the clinical trials of pharmaceuticals, biotechnology, and medical devices. This includes, but is not limited to, professionals in Research and Development, Quality Control, Quality Assurance, and Regulatory Affairs. The course will also benefit those in other departments who find clinical trials among their responsibilities.
- Regulatory Agency Expectations In Several Countries/Regions
- International Bodies Which Oversee Clinical Trial Reporting
- Biomedical And Biostatistical Implications Of Trials Conducted In Non-Target Markets
In addition, attendees will gain the background knowledge necessary to effectively plan clinical trials programs, as well as, develop expertise in writing protocols and reports and provide an assessment of the validity of a trial based on location, genetic and cultural issues. Participants will have acquired insight into how to design and operate a clinical trial.
This course provides comprehensive and up-to-date knowledge of internationalization of clinical trials of pharmaceuticals, biotechnology, and medical devices. The course covers regulatory expectations regarding clinical trials as contained in U.S., E.U., and International regulations and guidelines. The guidelines of the International Conference on Harmonisation (ICH) and European Union will receive special attention and coverage. This course will prepare attendees to plan and execute effective and compliant clinical trials.
Additionally, the course will cover biostatistical issues related to population selection, and both short-term and long-term cost considerations of non-target-market trials. While the course will be addressing some Approvals Submissions issues, it is primarily focused on individual clinical trials protocol development and implementation.
In addition, there will be ample time to address specific problems and questions of individual participants.