Regulatory Affairs & Regulatory Submissions
Session 1
Introduction to Drug Development and Regulatory Affairs
Session 2
The Drug Development Lifecycle
Session 3
Regulatory Frameworks and Authorities
Session 4
The Role of Regulatory Affairs Professionals
Session 5
Understanding Global and EU Regulatory Landscape
Session 6
Medicines Legislation in the EU and UK
Session 7
Thermal Mapping and Qualification of Storage Facilities and Distribution Vehicles
Session 8
Pest and Rodent Control in Pharmaceutical Warehouses
Session 9
Products Distribution and Freight Forwarding for FDA-Regulated Products
Session 10
ERP Systems and Compliance in Pharmaceutical Distribution
Session 11
Supplier and Customer Approval, and Vendor Management
Session 12
Handling Rejections, Disposal, and Segregation of Products
Session 13
Prevention and Management of Falsified Products in Distribution
Our Courses
- Introduction to GMDP Regulations and Importance of GMDP
- Pharmaceutical Quality System (PQS)
- Personnel
- Premises and Equipments
- Documentation
- Production
- Quality Control
- Outsource Activities
- Complaints, Quality Defects, and Product Recalls
- Self-Inspection and Audit
- Good Distribution Practice (cGDP)
- Regulatory Affairs & Regulatory Submissions
