The course is designed to provide a comprehensive understanding of the entire drug development process, including post-market surveillance, safety management, and regulatory compliance. The course will cover the various stages of drug development, from preclinical trials to post-market surveillance and safety management.
Students will learn about the importance of pharmacovigilance in ensuring the safety of drugs and managing adverse events. This includes understanding the regulatory framework and guidelines for pharmacovigilance compliance, as well as the processes involved in identifying and reporting adverse events.
The course will also cover the various stakeholders involved in pharmacovigilance, such as regulatory agencies, pharmaceutical companies, healthcare professionals, and patients. Students will learn about the roles and responsibilities of these stakeholders in ensuring drug safety and compliance with regulatory requirements.
Other topics that will be covered in the course include risk management plans, signal detection, risk-benefit analysis, and drug safety communication. Students will also learn about the importance of data management and analysis in pharmacovigilance and drug safety.
Upon completion of the course, students will have a comprehensive understanding of drug lifecycle safety management and pharmacovigilance compliance, and will be able to apply this knowledge to real-world situations in the pharmaceutical industry.
Learning Points:
