Good Pharmacoepidemiology Practice
On completion of this module, you should be able to follow good practice in:
• Planning pharmacoepidemiological research
• Collecting data in such research
• Analysing data from pharmacoepidemiological studies
• Interpreting and communicating the results of such studies
What will you learn?
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, ecacy 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.
Course outline
Module overview -An outline of the module’s scope and objectives, and a glossary of terms.
Study planning and data collectionIn 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 communicationIn 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
Who Should Attend?
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.
Learning & Career benefits
Our online training offers a wide range of benefits for professionals seeking to enhance their knowledge and expertise.
- World-Class Training
Learn from TÜV SÜD’s industry experts and training specialists.
- Flexible Learning Style
Study in your own time, at your own pace
- Continuous Feedback
Get prompt feedback from content-embedded assessment.
- Professional Certification
Get a globally recognized certificate and enhance your career development.
FAQ
System requirements
- Chrome
- Safari
- Internet Explorer
- Firefox
- A high-speed internet connection will provide best results.
- An email address is required to register for courses.
- Microsoft Media Player or equivalent is needed to play audio and video files.
- Flash Player is used for content and interactive learning. If necessary, download and install Flash Player to ensure proper operation of course content.
1. What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.
2. Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).
3. Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.
4. Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.
5. What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.