Course overview
This two-day course on provides a comprehensive overview of international standards and best practices in drug safety monitoring. Day 1 focuses on Clinical Safety, covering pre-clinical safety, ICH E guidelines for safety data capture, adverse event reporting, and risk management strategies in clinical trials. Participants will gain insights into signal detection, investigator brochure requirements, and regulatory obligations across trial phases. Day 2 shifts to Post-Marketing Safety, addressing ICH E2D standards, post-marketing vigilance, safety information updates, and risk mitigation strategies.
CPD Hours: 12
Course Content
- Day 1
- Clinical safety - international standards (ICH)
- ICH EA individual (serious) adverse event data capture and reporting
- Safety information and the Investigator Brochure (IB)
- Safety information and the protocol (ICH E6 R3)
- Signal detection in clinical trials
- Risk Management Plans (RMPs) and mitigation strategies from clinical trials
- Day 2
- Post-marketing safety - International Standards (ICH)
- ICH E2D individual (serious) adverse event data capture and reporting
- Safety information and the Summary of Product Characteristics (SPC)/product monograph
- Safety information and post-marketing studies
- Signal detection in post-marketing products
- Risk Management Plans (RMPs) and mitigations strategies from post-marketing
Speakers
Graeme Ladds
Graeme is Director of PharSafer and has over 30 years’ experience working in the pharmaceutical industry, having started his career at Ashbourne Pharmaceuticals as Head of Drug Safety and Medical Information. Graham has a wealth of experience establishing pharmacovigilance within companies.
