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Event Details


R2 Addendum- Changes Impacting Sponsors-CRO-Sites

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Who should attend?

Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs), Data Managers or others working in Biomedical Product Development and/or interested in transitioning into Clinical Trials Field Grant Administrators Regulatory Affairs Quality Control(QC), Quality Assurance Specialists


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
Project Managers
Grant Administrators
Regulatory Affairs
Quality Control(QC), Quality Assurance Specialists

Speaker Profile:
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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407


One Dial-in One Attendee Price: $150.00


Event Manager

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