Students will learn about the ethical considerations and informed consent process for clinical research and post-marketing surveillance, including the protection of human subjects and the role of Institutional Review Boards (IRBs) and Ethics Committees. The course will also cover the regulatory requirements for the collection, assessment, and reporting of adverse events, including the development of risk management plans and post-marketing surveillance studies.
The course will focus on the principles of GVP, including the importance of quality control and assurance in pharmacovigilance, and the responsibilities of sponsors, investigators, and pharmacovigilance professionals. Students will learn about the principles of data management and the importance of maintaining accurate and complete study documentation.
Upon completion of the course, students will have a thorough understanding of the regulatory framework, ethical considerations, and principles of GVP. Students will also be prepared to apply this knowledge to the design and conduct of clinical trials and post-marketing surveillance studies to ensure compliance with regulatory requirements and to safeguard patient safety.