Webinar on The New European Clinical Trial Regulation

Event Details

Time: April 6, 2016 from 10am to 11:30am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://bit.ly/European_Clinic…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Feb 25, 2016

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Event Description

Overview:

This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

Who Will Benefit:

Clinical Operations Staff
Project Team Members
Quality Assurance, Monitors, CRAs
Regulatory Affairs
Investigators & Site Study Staff
Clinical Trial Supply
CROs, Consultants, Insurers

Speaker Profile:

Robert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/European_Clinical_Trial_Regulation

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