Mastering Regulatory Affairs: From Drug Development to Global Compliance
in Pharma, Biotechnology, and Healthca...About this course
Understand the fundamentals of regulatory affairs and its role in the pharmaceutical industry.
Before We Begin
1 Parts
- 0:20 Hr
Before We Begin
20 Min
Prerequisites & Readiness Check
1 Parts
- 0:15 Hr
Prerequisites for Mastering Regulatory Affairs & Global Compliance
15 Min
Chapter 1: Introduction to Regulatory Affairs
3 Parts
- 2:00 Hr
Role of Regulatory Affairs
45 Min
Regulatory Intelligence Basics
45 Min
Career Opportunities
30 Min
Chapter 2: Drug Development Lifecycle
2 Parts
- 1:30 Hr
Stages of Drug Development
45 Min
Regulatory Strategy Development
45 Min
Chapter 3: Global Regulatory Frameworks
3 Parts
- 2:15 Hr
Major Regulatory Bodies
45 Min
Global Harmonization
45 Min
Health Technology Assessment (HTA)
45 Min
Chapter 4: Clinical Trials and Pharmacovigilance
2 Parts
- 1:30 Hr
Clinical Trials Regulations
45 Min
Pharmacovigilance Strategies
45 Min
Chapter 5: Quality Management and Compliance
3 Parts
- 2:15 Hr
Good Manufacturing Practice (GMP)
45 Min
Compliance and Ethics
45 Min
Good Distribution Practice (GDP)
45 Min
Chapter 6: Labeling, Packaging, and Sustainability
2 Parts
- 1:30 Hr
Labeling Requirements
45 Min
Packaging and Sustainability
45 Min
Chapter 7: Emerging Therapies and Digital Health
2 Parts
- 1:30 Hr
Emerging Therapies
45 Min
Digital Health Regulations
45 Min
Chapter 8: Advanced Regulatory Strategy and Leadership
2 Parts
- 1:30 Hr
Advanced Regulatory Strategy
45 Min
Regulatory Leadership
45 Min
Capstone Project 1
1 Parts
- 1:40 Hr
Global Regulatory Submission Dossier Builder
100 Min
Capstone Project 2
1 Parts
- 1:40 Hr
Regulatory Crisis Leadership Simulation & Playbook
100 Min
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