This comprehensive Drug Development Training Program provides a structured understanding of the entire drug development lifecycle - from drug discovery and preclinical research to clinical trials, regulatory approval, commercialization, and post-marketing surveillance.
Participants will gain practical insights into how pharmaceutical products are discovered, developed, tested, approved, and successfully brought to market, with a strong focus on FDA regulations, ICH guidelines, Good Clinical Practice (GCP), regulatory affairs, quality systems, and industry best practices.
Learn the essential scientific, regulatory, and commercial principles that drive successful pharmaceutical and biotechnology product development.
Participants will gain practical insights into how pharmaceutical products are discovered, developed, tested, approved, and successfully brought to market, with a strong focus on FDA regulations, ICH guidelines, Good Clinical Practice (GCP), regulatory affairs, quality systems, and industry best practices.
Learn the essential scientific, regulatory, and commercial principles that drive successful pharmaceutical and biotechnology product development.
Course Content
Day 1: Drug Discovery, Preclinical Development & Regulatory Foundations
Session 1: Drug Development Landscape (2026 Perspective)
Session 2: Drug Discovery & Preclinical Development
Session 3: CMC & Pharmaceutical Development
Session 4: Regulatory Strategy & IND Submission
Day 2: Clinical Development, GCP & Digital Clinical Trials
Session 1: Clinical Trial Development
Session 2: Good Clinical Practice (ICH E6(R3))
Session 3: Digital Transformation in Clinical Research
Session 4: Clinical Safety & Pharmacovigilance
Day 3: Regulatory Approval, Commercialization & Lifecycle Management
Session 1: Marketing Authorization & Regulatory Approval
Session 2: Commercial Manufacturing & GMP
Session 3: Post-Approval Changes & Lifecycle Management
Session 4: Post-Marketing Surveillance & Future Trends
Speaker
Kelly ThomasWho Should Attend
- Drug Discovery, Research & Development (R&D) Scientists
- Clinical Research and Medical Professionals
- Regulatory Affairs Professionals
- Quality Assurance (QA) and Quality Control (QC) Professionals
- CMC and Pharmaceutical Development Professionals
- Manufacturing and Production Personnel
- Pharmacovigilance and Drug Safety Professionals
- Project Managers and Auditors
- Biostatistics and Data Management Professionals
- Sales, Marketing, Brand and Commercial Teams
- New Employees and Non-Scientific Professionals seeking an understanding of the drug development process
- Anyone looking to build or enhance their knowledge of pharmaceutical drug development
