Good Clinical Practices (GCP) – Understanding and Implementing the Current Global Requirements

This three-day GCP training course is designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements. The course consists of lecture and exercises designed to focus on the practical implementation of the GCP requirements. Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent form for completeness and compliance; conducting drug accountability; reviewing case report form for accuracy and adherence to protocol and performing source document verification.

The GCP training course will also provide the attendee with thorough knowledge of the following topics:

• How drugs are discovered and developed for marketing approval
• The four different study phases of clinical research
• What constitutes Good Clinical Practices (GCP)
• Regulatory updates
• How the requirements differ in the US, EU, India, China & Japan
• The principles of ICH GCP
• The IRB/IEC’s composition and role/responsibilities
• The IRB study review & approval process
• The role and responsibilities of the investigator & study site staff
• The role and responsibility of the sponsor
• The history of the FDA & EMA and their role & responsibilities
• Which sections of 21 CFR and ICH Guidelines govern conduct of clinical studies
• The purpose for an IND / CTA and its composition
• How INDs & CTAs are filed, reviewed, approved & amended
• The IND/CTA reporting requirements
• The requirements for Informed Consent
• How to review an Informed Consent form for compliance
• The process for Informed Consent review & approval
• The administration of subjects Informed Consent
• The different types of study Monitoring visits & tasks for each
• Adverse Events - the types and reporting requirements
• How to perform Drug Accountability & compliance
• How to manage study supplies
• How to detect and deal with Fraud
• The purpose and composition of the NDA/MAA
• How NDAs/MAAs are filed, reviewed and approved
• Sponsor responsibilities after approval
• How to review study documents & determine compliance
• How to review Case Report Forms and determine adherence to protocol

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.