Courses

MCELLBI X431 - Principles of Product and Process Development
PB HLTH 1023 - The Drug Development Process: An Intensive Seminar
PB HLTH X400.2 - Introduction to Clinical Research: Clinical Trial Phases and Design
PB HLTH X400.3 - Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
PB HLTH X400.4 - Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
PB HLTH X400.5 - Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management
PB HLTH X401.1 - CMC Regulatory Compliance for Pharmaceutical Products
PB HLTH X401.4 - Good Manufacturing Practices (GMP): Quality Assurance (QA) in Practice
PB HLTH X401.5 - Inspections and Audits for Quality and Compliance
PB HLTH X401.6 - Principles of Quality and Compliance
PB HLTH X401.7 - Good Manufacturing Practices (GMP): Quality Control (QC) in Quality and Compliance
PB HLTH X401.8 - Validation and Interfacing With Quality Assurance (QA)
PB HLTH X401.9 - Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
PB HLTH X402.1 - Harmonization Across Worldwide Applications
PB HLTH X402.2 - BLA/NDA/MAA Submissions and Commercialization
PB HLTH X402.3 - IND/CTA Preparation and Submission
PB HLTH X402.4 - IND/CTA Enabling Studies and Agency Interfaces
PB HLTH X403.1 - Post-Approval Activities
PB HLTH X404.8 - IND/CTA Preparation, Submission and Agency Interfacing
PB HLTH X475.7 - Principles of Supply Chain and Manufacturing