- To provide Ethics Committee team members understanding of drug development process,
ICH GCP Principles, Indian GCP, Ethical Considerations and conduct & management
of clinical trials.
- To provide complete knowledge of regulatory issues, recent amendments, documentation
and roles of responsibilities of all stake holders
- To provide members with the detailed knowledge on the conduct and management of
clinical trials
- ICH GCP Principles / Declaration of Helsinki / Indian GCP and Schedule Y
- Regulatory Environment
- Ethical Considerations & Subject Recruitment & Compensation Issues
- Roles & Responsibilities of Ethics Committee, Investigators and other Key Stakeholders
- Essential Documents in Clinical Research
- Drug Safety Reporting
- Monitoring
- Audits & Inspections
- One or two day workshop
- Presentations by experienced trainers
- Evaluation and certification by Cliniminds – Accredited by the Accreditation Council
for Clinical Research Education, USA
- Training record handover
- Printed and online presentations
- Ethics Committee SOPs Development and Review
- Ethics Committee Registration & Accreditation
- Annual Refresher Training
For more information and quotation, please call 09810068241 or email at info@cliniminds.com