Understanding Laboratory Results and Other Investigations (e.g. X-Ray, ECG) in the context of Adverse Drug Reactions
Understanding Laboratory Results and Other Investigations (e.g. X-Ray, ECG) in the context of Adverse Drug Reactions
Venue: Solent Hotel, Rookery Avenue, Whitely, Fareham, Southampton
Date:
28 - 29 Mar 2012
Cost per delegate:
£700.00 + VAT
or
£460.00 + VAT (academic units, public sector organisations, registered charities)
Course Outline
Staff who deal with patient data such as pharmacovigilance reports and CRFs (both at individual case report level and collective reports, e.g. issue analyses, PSURs, risk management documents, end of study reports) need to understand results of investigations such as laboratory tests, ECGs, ultrasound scans etc. Results of such investigations are frequently part of the data which need to be assessed or commented upon when handling pharmacovigilance / clinical research data.
Aims
To enable pharmacovigilance staff and other professionals to understand and interpret results of investigations that they deal with in their pharmacovigilance work.
Key Topics
Programme features
- Laboratory investigations including haematological, biochemical and other lab tests
- Renal, hepatic, histological, respiratory and cardiovascular investigations and results
- ECGs including common abnormal findings
- Imaging (Xrays, ultrasound, CT and MRI scans)
- Other investigations such as EEGs and bone scanning
- Laboratory data in aggregate post-marketing safety analyses
- Workshop exploring examples of how lab and investigation results are used in pharmacovigilance
Learning Outcomes
On successful completion of this course delegates should be able to:
- Relate lab and investigation results to clinical findings and put them in context in pharmacovigilance assessments
- Understand how to deal with results of investigations including the principles of normal vs. abnormal
- Appreciate the significance of abnormal laboratory / X-ray results included in case reports