Course Features
Course Instructor: Vanercia
Who should do it: Bachelors (Pursuing / Completed) and above
Assessment:Exams at end of course, Quiz and Assignments
Certificate: Yes
Course Details
With the augmented medicines use, the public awareness of safety issues with respect to its usage has gained the spotlight. The research and development of drugs, clinical trials data management, risk and safety management and operations organizational alignment are the important pillars of the drug industry. Patient’s safety is the top most priority of the pharmaceutical industry. Trained professionals are therefore in great demand to align the operations at various levels. The modules of this course are designed keeping in mind the nature of operation in the drug industry.
Learning Outcomes
- This course provides an insight into approaches to data collection and Database designing and Quality analysis in clinical data management.
- Basic concept and of pharmacovigilance
- Pharmacovigilance process and regulatory aspect of pharmacovigilance
- The course includes online-lectures, presentations and project-based training designed on the inputs from academia and industry.
- Quiz and assignments based on modules covered for practice.
Course Modules
- Overview of Clinical Data Management clinical data.
- Approaches to data collection and Database designing.
- Quality analysis in clinical data management.
- Data cleaning.
- AI in clinical data management.
- Basic concept of pharmacovigilance.
- Types and source of data in pharmacovigilance.
- Pharmcovigilance process.
- Regulatory aspect of pharmacovigilance.
- Clinical Aspects of Adverse drug reactions.
