The recent changes in the requirements for initiating clinical trials within the European Union apply to all clinical trials of medicinal products (including Biologics). This includes all studies held in the European Union (EU), and studies outside the EU which are to be submitted for marketing authorization in Europe. The new EU Regulation (EU No 536/2014) replaces the previous EU Directives (2001/20/EC, 2003/94/EC and 2005/28/EC), with many changes. This has led to confusion from sponsors, Contract Research Organizations (CROs), and sites. Requirements for implementation of and compliance to the EU Regulation have begun: all newly initiated clinical trials must follow these requirements. The question for most of us remains: How do we maintain strict compliance and mitigate risk?
This interactive, 90-minute presentation will provide you with an understanding of key updates, major differences, and common trouble spots. Attending will give you the tools necessary to set a foundation for compliance.
By attending this presentation you will learn…
This course will benefit individuals involved in initiating and conducting clinical trials within the European Union or on trials meant to support marketing authorization within the EU. Those working within a Sponsor’s or CRO’s clinical operations and regulatory affairs groups, as well as investigators conducting Investigator Initiated Trials, will find this session extremely beneficial.
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.