Course overview
This comprehensive one-day course provides an in-depth introduction to signal detection in pharmacovigilance. Participants will explore the history, regulatory requirements, and practical processes involved in detecting, validating, and acting upon safety signals. Through expert-led discussions and real-world case studies, attendees will gain a foundational understanding of how signal detection supports patient safety and regulatory compliance.
CPD Hours: 6
Course Content
- Day 1
- The history of signal detection
- Regulatory requirements for signal detection
- Regulatory expectations (post-marketing for signal detection)
- Signal detection process
- From signal to labelling
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.
