Regulatory Affairs – CMC, New Licensing, and Life Cycle Management Course

This comprehensive course is designed for professionals seeking foundational and advanced knowledge in Regulatory Affairs. It covers the fundamentals of regulatory compliance, market authorization procedures, dossier preparation with a focus on eCTD and CMC documentation, and effective management of variations and product updates. Participants will also gain expertise in labeling compliance, quality assurance, risk management, and digital submission tools. The course emphasizes real-world applications, including health authority communication and regulatory intelligence. Additionally, career development sessions will prepare attendees for roles in the dynamic regulatory environment, equipping them with essential skills to excel in the pharmaceutical and biotech industries.