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Our Pharmacovigilance Training
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EC Training Helpline : +91 98100 68241 - WhatsApp
Established in 2004, Cliniminds is at the forefront of providing IRB / EC Training Programs. Have trained over 8,000 clinical research professionals globally.
ETHICS COMMITTEES GCP & CLINICAL TRIALS MANAGEMENT TRAINING PROGRAMS.
Online GCP Training – Training Content Access through Cliniminds Learning Management System & Live Sessions with GCP Experts.
Ethics Committees play an important role in the ethical and scientific conduct of clinical trials. It is now mandatory for the ECs to have annual GCP training. With the new regulatory environment, role of ECs has become more vital, hence, sound understanding of GCP, regulations, roles & responsibilities of stake holders, essential documents. Hence, annual refresher trainings are important.
Objectives:
  • To provide Ethics Committee members understanding of drug development process, ICH GCP Principles, Country Specific GCP Guidelines, Ethical Considerations and drug development process
  • To provide complete knowledge of regulatory issues, compensation, recent regulatory 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
Topics:
  • ICH GCP Principles & Country Specific Regulations / Guidelines
  • 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
Workshop Format:
  • One or two day online workshop
  • Presentations by experienced trainers
  • Evaluation and certification by Cliniminds – Accredited by the Accreditation Council for Clinical Research Education, USA
  • Presentations access through Cliniminds Learning Management System
Other Services:
  • Ethics Committee SOPs Development and Review
  • Ethics Committee Registration & Accreditation Services
  • Annual Refresher Training
For more information and quotation, please call +91 9810068241 or
info@clinimindscom www.cliniminds.com
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