CRPV109 Global Clinical Research and Pharmacovigilance

The course describes the pharmaceutical industry as a global enterprise, focusing on conducting global clinical research and the role of the Contract Research Organizations: the need, implications, regulatory considerations, challenges, and advantages. Students will have a strong understanding of the objectives and challenges of pharmacovigilance and pharmaceutical R&D on a global scale. The ethical and regulatory considerations of global clinical research as well as the role of Clinical Research Organizations (CROs) is discussed in detail.

Learning Points:

• The Global Pharmaceutical Industry: it’s Drivers and Challenges
• Role of the Contract Research Organizations (CROs) in the Pharmaceutical R&D
• Global Clinical Research and Pharmacovigilance: Ethical and Regulatory Considerations and Guidelines
• Pharmacovigilance Basics and Global governance
• Case Reporting, Signal detection, and Risk Management
• Organizational Structure of Global Pharmaceuticals and CROs
• Overview of Biopharmaceuticals Products Pipeline