Course overview
This comprehensive two-day course provides an in-depth understanding of literature searching in drug safety, focusing on regulatory requirements, literature search criteria, and the interpretation of safety data from published sources. Participants will explore best practices for conducting literature searches, identifying relevant safety information, and prioritising articles for review. Practical assessments will enable attendees to apply their knowledge to real-world case studies, ensuring they are equipped with the necessary skills to effectively manage literature searches in pharmacovigilance.
CPD Hours: 12
Course Content
- Day 1
- The regulations concerning literature searchin
- The literature search criteria
- What literature articles need to be reviewed
- Prioritisation of literature articles
- Literature article reviews
- Day 2
- Practical assessment of literature article and ICSRs
- Practical assessment of a pre-clinical finding in the literature
- Practical assessment of a clinical study
- Practical assessment of a study involving the company
- Practical assessment of a pharmacoepidemiological study
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.
