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EU Clinical Trial Regulation Implementation | Regulatory 2018

Event Details

EU Clinical Trial Regulation Implementation | Regulatory 2018

Time: February 14, 2018 at 9am to February 15, 2018 at 6pm
Location: Hilton Zurich Airport
Street: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
City/Town: Zurich, Switzerland
Website or Map: http://www.globalcompliancepa…
Phone: 800-447-9407
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Dec 7, 2017

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Event Description

Overview:

 

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This course covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

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