The regulations worldwide require pharmaceutical firms, biopharmaceutical companies, and marketing authorization holders (MAH) to report all adverse events (AE) for which there is a reasonable possibility that their medication caused the event. Yet, sponsors and manufacturers often are cited for not being in compliance with these regulations. The process requires a critical attention to detail, well-written protocols and standard operating procedures (SOPs), and concise, audit-ready reporting. This course will also address the current adverse events report format and content for non-approved medicinal products (Drug Safety Update Reports - DSURs). A sample DSUR will be provided. The newly-required Periodic Benefit-Risk Evaluation Report (PBRER) and content will be discussed. Any differences between the US and EU requirements will be highlighted.
This webinar will discuss how you can run a compliant, efficient AE reporting program. By attending this 90-minute interactive session, you will:
This course will be of benefit to anyone involved in clinical trial design, oversight and/or adverse event reporting.
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.