- URL: http://www.lifesciencetraininginstitute.com/doc/clinical-study-requirements-understanding-differences-between-the-us-and-eu-0001
- Date: 11/28/2016
- Listed: November 14, 2016 9:54 am
- Expires: This ad has expired
Clinical Study Requirements – Understanding Differences Between the US and EU
Date: November 28, 2016
Time: 1:00pm-2:30pm, EST US
Duration: 90 Minutes – Online
Price: $299 – Includes Bonus Handouts!
Even with increased efforts to harmonize regulatory requirements between the US and European Union, the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) have different requirements for initiating and conducting clinical trials for medicinal products. Deciding which standards to follow and how to harmonize/organize your own efforts is a daunting task. Thankfully, there are ways to avoid these pitfalls and ensure compliance.
This Webinar will discuss these differences in detail while providing guidance on how to mitigate risk. By attending this interactive, 90-minute session you will:
Learn key differences in the regulatory and IRB submission and reporting processes as well as the differences in roles and responsibilities
Understand the different requirements for conducting and closing a study
Tips on how to choose the right standard to ensure compliance
Sort through the noise: Understand what the critical mandates really mean
Who Should Attend
This course will be of benefit to anyone involved in initiating and conducting global clinical trials Phases I-III.
For over 10 years, Michael Pierro has provided consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures, Project Management and Clinical QA GCP auditing) and GCP/SOP training (live & Internet delivery). In this work, he draws on over 30 years of experience in clinical operations and training in the pharmaceutical & biotechnology industry.
Previously employed by Barnett International, Michael served as Director, Business Development: Consulting & Clinical Training responsible for development and implementation of GCP related standard operating procedures, specialized compliance related training programs and related consulting services. Clients include Pharmaceutical, Biotechnology, CROs, University Medical Centers and US Federal Government.
Immediately prior to joining Barnett, Michael was Director of Global Training for Hoechst Marion Roussel’s (Aventis) Global Clinical Quality Assurance Department. In this role, he directed all GCP Auditing, SOP and technical training programs and activities within the company’s Global Drug Development Center and other development sites throughout the world. In previous roles with Hoechst Marion Roussel and other major pharmaceutical companies, Michael served as a Senior CRA, Manager of Phase IV Clinical Operations and Chairperson of the SOP Steering Committee and GCPAuditor. He was involved in several NDA and SNDA preparations and filings as well as other reports to the regulatory agencies.
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