New Clinical Trial Regulations by the European Union (EUCT Regulation 536/2014)

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Thu, Sep 08, 2016
Length
90 minutes
Product Description

New EU Clinical Trial Regulations & Recent Updates on the EU Pharmacovigilance Directive


The newly proposed requirements for conducting clinical studies across the European Union, (EU) via the requirement of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products), will affect all sponsors of clinical studies in the EU. Knowing what changes will be implemented now will allow all sponsors the time to adjust their processes and responsibilities across the EU.

This webinar by expert speaker Robert J. Russell will discuss the newly proposed requirements for EU Clinical Trial Regulation and cover recent updates on EU-GCP associated with the EU Clinical Trial Directive 2001/20/EC.

This session addresses the important highlights of the new EU Pharmacovigilance Directive, as it relates to studies and offers helpful tips into working with the European regulators. It will provide an overview of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.

Session Highlights:

  • Overview of the EU and the EU Regulatory Structure
  • Marketing Authorization Options in the EU and Linkage to Conducting Clinical Studies
  • Overview of the European Union Clinical Trial Regulation 536/2014
  • Pertinent, Critical Articles of Regulation 536/2014
  • Processes and Timelines
  • The Ethics Committee
  • Phases of a Clinical Trial
  • Trial Protocol and Project Management
  • Investigational Medicinal Product Dossier
  • Standard Operating Procedures
  • Clinical Trial Authorization Application
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Pharmacovigilance – New EU Requirements Overview
  • End of a Clinical Trial
  • Databases
  • European Union vs. The United States
  • Regulatory Process
  • Q&A Session

Who Should Attend

  • Clinical Operations Staff
  • Project Team Members
  • Quality Assurance, Monitors, CRAs
  • Regulatory Affairs
  • Investigators & Site Study Staff
  • Clinical Trial Supply
  • CROs, Consultants, Insurers
  • Clinical Research Professionals
  • Project Team Members
  • Associated Disciplines Conducting Clinical Studies Across the European Union

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Robert J. Russell

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.


Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
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