Adverse Event Reporting & Pharmacovigilance

Product recall is a real disaster, especially when it could have been avoided through accurate drug safety reports and quick reaction to postmarket safety issues. Industry cannot afford to waste the investments made in the clinical and marketing activities of new products through poor ADR reporting practices.

This course will review the regulatory environment in which you operate and will guide you through the vast number of Directives, regulations and guidelines. You will be given the chance to work on case study exercises to produce practical advice and develop adequate strategies to handle reporting requirements.

If you need to gain in-depth knowledge on the best way to prepare for, collect and report adverse events, then this is the course for you. Its unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety programme.

Performance & Knowledge Objectives of this Course:

• Effectively monitor your drug reactions and avoid being blamed for negligence
• Minimise post-marketing issues that can adversely affect your drug sales revenue
• Perform accurate causality assessment to identify the exact origin of your ADRs
• Identify and follow up the key signals over time to take preventive actions
  EU requirements: what are the Directives, regulations and guidelines and when do they apply?
• Compile and present key information in your adverse event reports in a clear format and reduce errors of interpretation
• Examine the practical impact of global harmonisation: ICH and CIOMS
• Prepare periodic safety update reports (PSUR) within the required timeframe