The Regulatory Affairs in Pharma program provides comprehensive training in pharmaceutical regulations, compliance, and regulatory submissions. This course equips professionals with the knowledge and skills needed to navigate complex regulatory environments and ensure compliance with global pharmaceutical regulations.
Participants will learn to prepare regulatory submissions, manage compliance requirements, and understand the regulatory landscape across different markets.
Key Learning Outcomes:
- Master global pharmaceutical regulations and guidelines
- Learn to prepare and submit regulatory documents
- Understand regulatory compliance and quality systems
- Develop skills in regulatory strategy and planning
- Gain expertise in post-marketing regulatory requirements
- Learn to manage regulatory inspections and audits
Who Should Enroll:
- Regulatory Affairs professionals and managers
- Quality Assurance professionals in pharma
- Clinical Research professionals
- Medical Affairs and Medical Writing professionals
- Graduates in Pharmacy, Life Sciences, or Medicine
- Professionals seeking career transition to regulatory affairs
Prerequisites:
- Bachelor's degree in Pharmacy, Life Sciences, or related field
- Basic understanding of pharmaceutical industry
- Good command of English language
- Computer literacy for document preparation
- Attention to detail and analytical thinking
Module 1: Introduction to Regulatory Affairs
- Role of regulatory affairs in pharmaceutical industry
- Global regulatory landscape and key agencies
- Regulatory strategy and planning
- Regulatory intelligence and monitoring
Module 2: Drug Development and Regulatory Process
- Pre-clinical regulatory requirements
- IND/CTA submission process
- Clinical trial regulatory approvals
- Marketing authorization applications
Module 3: Global Regulatory Guidelines
- ICH guidelines and harmonization
- FDA regulations and requirements
- EMA guidelines and procedures
- Regional regulatory variations
Module 4: Common Technical Document (CTD)
- CTD structure and format
- Module 1: Regional administrative information
- Module 2: Quality, non-clinical, and clinical summaries
- Module 3: Quality information
- Module 4: Non-clinical study reports
- Module 5: Clinical study reports
Module 5: Quality and Manufacturing Regulations
- Good Manufacturing Practice (GMP)
- Quality by Design (QbD) principles
- Process validation and control
- Quality systems and documentation
Module 6: Post-Marketing Regulatory Requirements
- Post-marketing surveillance
- Periodic safety update reports
- Labeling and packaging regulations
- Advertising and promotion guidelines
Module 7: Regulatory Compliance and Inspections
- Regulatory inspection preparation
- Compliance monitoring and auditing
- Corrective and preventive actions
- Regulatory enforcement and penalties
Module 8: Emerging Trends and Future Directions
- Digital health and technology regulations
- Personalized medicine and biomarkers
- Real-world evidence and health economics
- Global harmonization initiatives
Student Reviews
Ravi Sharma
December 20, 2025
Excellent course with experienced instructors who have worked in regulatory affairs. The case studies and real-world examples made complex regulations easy to understand.
Dr. Priya Reddy
November 30, 2025
The course structure is well-organized and covers both theoretical knowledge and practical skills. The regulatory intelligence module was particularly valuable for my career development.
Dr. Anjali Mehta
January 8, 2026
Comprehensive course that covers all aspects of regulatory affairs. The practical exercises with real regulatory documents were extremely helpful. I now feel confident to handle regulatory submissions.