Description

Regulatory affairs – CMC, new licensing and life cycle management.

Module 1: Fundamentals of Regulatory Affairs and Compliance

• Overview of Regulatory Affairs roles and responsibilities
• Regulatory bodies: MHRA, EMA, FDA, ICH, CMDh
• Drug lifecycle stages and the role of regulatory submissions
• Compliance frameworks: GMP, GLP, and GCP

Module 2: Regulatory Procedures and Market Authorizations (MAA)

• Overview of CP, DCP, MRP, and National Procedures
• Preparation and submission of MAAs to MHRA and EMA
• Handling sunset clauses, renewals, and withdrawals
• Key differences between national and mutual recognition procedures

Module 3: Dossier Preparation: Focus on eCTD and CMC Module 3

• Structure of CTD and eCTD submissions
• Compilation and submission of Modules 1 & 3 (administrative and quality)
• CMC (Chemistry, Manufacturing, and Controls) documentation
• Working with ASMF and CEP drug substance sections

Module 4: Variations and Updates Management

• Types of Variations: Type IA, Type IB, and Type II
• Processes for major and minor variations
• Preparation of safety updates (PSUSA, PRAC)
• Handling 61.3 notifications and change of ownership requests

Module 5: Product Information and Labeling Compliance

• Preparation and review of SmPC, PIL, and labelling
• Comparative SmPC & PIL updates for submission
• Regulatory review for artwork approvals
• Managing Windsor Framework and Brexit-related updates

Module 6: Quality Assurance and Risk Management in Regulatory Affairs

• Working with batch records (BMR, BPR) and change control processes
• Handling incidents, deviations, and CAPA implementation
• Preparing annual product quality reports (APQR)
• Conducting market complaint investigations and customer communication

Module 7: Digital Submissions and Tools in Regulatory Affairs

• eCTD software tools for submission and tracking
• Database management for tracking regulatory submissions, queries, and approvals
• Overview of health authority communication platforms (e.g., MHRA portal)
• Working with cross-functional teams to arrange regulatory documentation

Module 8: Career Development and Future Trends in Regulatory Affairs

• Interview preparation and soft skills for Regulatory Affairs positions
• Overview of legislation updates and staying compliant
• Building regulatory intelligence and competitive strategies