Regulatory Affairs for Drugs and Biologics

This introductory course provides a comprehensive overview of the drug development process, from initial development through regulatory approval and commercialization. The course emphasizes the role of regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonization (ICH). Students will explore key aspects of regulatory compliance, including the roles and responsibilities of professionals across the pharmaceutical and biotechnology sectors, as well as the legal frameworks that govern the industry,...

This course provides a comprehensive overview of the regulatory pathways and submission processes for drugs and biologics from early development through market approval. Students will learn to prepare and submit Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and their global equivalents. The course covers the structure, content, and technical requirements of regulatory submissions and the roles of key health authorities, including the FDA and EMA. Emphasis is placed on strategic planning, electronic submission standards...

The drug development process is complex, involving multiple stakeholders and stringent regulations designed to protect clinical trial participants while ensuring public access to safe, effective, and high-quality medicinal products. To support successful commercialization, sponsors must generate robust data in compliance with global regulatory requirements. This course focuses on developing effective regulatory strategies and fostering productive engagement with health authorities throughout the lifecycle of drug and biologic development. Students will learn how to align regulatory planning...

Topics include the definition and identification of good clinical practices (GCPs); how GCPs affect the conduct of clinical trials; regulating agencies and applicable regulations from the Code of Federal Regulations and ICH guidelines; state regulations; obligations of investigators, sponsors, monitors, and IRBs; compliance and accountability during clinical trials; protocol violations and deviations; consequence of falsification of data and/or patient records; and the blacklist. Device regulations also covered.

Artificial intelligence (AI) is revolutionizing healthcare by improving how we diagnose diseases and manage patient care. This course, "Introduction to AI in Healthcare," is designed for healthcare professionals who want to understand and apply AI in their daily work. It covers the essentials of AI, showcases its real-world uses in medicine, and discusses the ethical aspects of using AI responsibly. By the end of this course, participants will gain practical insights into AI's capabilities and limitations, preparing them to make informed decisions in a tech-driven healthcare environment....