The revised guidelines are entitled "Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2)." The ICH steering committee comprised of representatives from the pharmaceutical industry and the regulatory bodies of the United States, Japan, the European Union (EU), Canada, and Switzerland.
Why should you Attend:
In this webinar we will identify the changes impacting investigators, sites, Sponsors, CROs: responsibilities and roles and explain the impact of the revisions on clinical trials conduct and organizational practices.
Areas Covered in the Session:
GCP E6 R2 Guideline
Risk-based Quality Management (RBQM)
SOPs development and implementation, Standardization
Who Will Benefit:
Directors of Clinical Operations
Medical Affairs Specialists and Leaders of this Division
Quality Control(QC), Quality Assurance Specialists
Dr. Malikova has over fourteen years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Event Fee: One Dial-in One Attendee Price: US $150.00