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Good Pharmacoepidemiology Practice
Course Summary
Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This module will help those who plan and conduct such research, and analyse and report the findings, to follow good practice.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Planning pharmacoepidemiological research
• Collecting data in such research
• Analysing data from pharmacoepidemiological studies
• Interpreting and communicating the results of such studies
Who will benefit from this course
Staff working in drug safety and pharmacovigilance or clinical research departments of pharmaceutical and biotechnology companies will benefit from this module. It will also be of value to healthcare professionals.
Module Outline
• Module overview
– An outline of the module’s scope and objectives, and a glossary of terms.
• Study planning and data collection – In this session, we:
– Outline the role and formulation of a research question and study protocol
– Discuss the choice of study design and research methods
– Identify types of data source and means of data collection
– Summarise obligations for protection of subjects
– Discuss operational definition and validation of drug exposure, outcomes, and covariates
– Give examples of good practice in data collection, management, and verification
• Analysis, interpretation, and communication – In this session, we:
– Discuss data analysis and the interpretation of results
– Outline the role and formulation of a statistical analysis plan
– Describe obligations for provision of a study report and communication of findings
• Assessment
– Multiple-choice mastery assessment.
Roles
Drug Safety, Research
CPD Points
1
Region
Level
Intermediate
Course Study Time
Approx 1 hour
USA, Europe, Other