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Site language : English - Français
Ref : 28063
Event :R2 Addendum- Changes Impacting Sponsors-CRO-Sites

Date :Tuesday November 06th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:
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
Globalization
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
Email: support@compliance4All.com

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Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

R2 Addendum- Changes Impacting Sponsors-CRO-Sites Medicine - Pharmacy - Bio-Technologies - National Health
education, healthcare
Everyone, Clinical, Regulatory, Research and Department (R&D) Staff who will Design Clinical Trial Programs 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
50 1 --
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