Regulatory Affairs ensures that pharmaceutical, biotech, and medical device products meet all legal and regulatory requirements throughout their lifecycle. Professionals prepare and manage essential documentation—such as INDs, NDAs, CTDs, and safety reports—and interact with global regulatory authorities to secure approvals and maintain compliance.
RWE & HEOR focus on understanding how medical treatments perform in real-life settings and evaluating their economic and health impact. RWE uses real-world data—such as electronic health records, insurance claims, and patient registries—to generate insights on effectiveness, safety, and patient outcomes. HEOR complements this by assessing the value of healthcare interventions, helping decision-makers optimize pricing, reimbursement, and resource allocation.
Pharmacovigilance, also known as drug safety, involves detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It ensures that medicines released into the market are continuously monitored for safety and effectiveness. This module provides an overview of key pharmacovigilance concepts, reporting systems, case processing, regulatory guidelines, and the role of safety monitoring throughout a drug’s lifecycle.
Clinical Trial Research involves the planning, execution, and analysis of studies that evaluate new drugs, devices, or treatments in humans. It includes protocol development, patient recruitment, site management, data collection, safety monitoring, and statistical assessment to ensure that interventions are safe, effective, and scientifically validated.