Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.">

R2 Addendum- Changes Impacting Sponsors-CRO-Sites

Start Date : November 6, 2018
End Date : November 6, 2018
Time : 10:00 am to11:00 am

Phone : (800) 447-9407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

Website

Description

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

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 has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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