Understanding & Implementing the New EU Clinical Trial Regulation

This course focuses on understanding and implementing the requirements of the new EU Clinical Trial Regulation and how it differs from the previous EU Directive and other country’s requirements. The Course covers all relevant topics associated with the Regulation, the reasons behind its replacement of the Directive and a review of methods for effective implementation.  The course consists of lecture and interactive exercises to re-enforce the learning.

Key topics to be discussed:

• The current regulatory situation in relation to clinical trials in the European Union
• The purpose of the Clinical Trial Regulation & why it replaces the Directive
• Implementing the EU Clinical Trial requirements 
• Understanding the impact the Regulation will have on running clinical trials
• A detailed explanation of the key differences between the EU Clinical Trials Regulation and FDA Regulations and ICH Guidelines
• The key differences between the EU Regulation and the requirements in China, India and Japan

Michael A. Pierro is consultant to life sciences industries; building on over 35 years of pharmaceutical-industry experience to provide services in clinical-practice areas of SOPs, study management and monitoring, auditing and site qualification.

Mr. Pierro previously served as Director of Business Development, Consulting and Clinical Training for a large consulting firm. There, he was responsible for the development and implementation of SOPs, specialized training programs and related consulting services. His clients included pharmaceutical and biotechnology firms, CROs, university medical centers and the United States government.

Before this, Mr. Pierro was Director of Global Training for the Global Clinical Quality Assurance Department of Hoechst Marion Roussel (now Aventis). In this role, he directed all GCP, SOP and technical training activities within the company's Drug Development Center and other sites throughout the world. In his other roles at the company; he served as a Senior CRA, Manager of Phase-IV Clinical Operations, Chairperson of the SOP Steering Committee and GCP Auditor. In addition, Mr. Pierro was involved in several NDA/SNDA preparations, filings and other reports to regulatory agencies.