Syllabus
US Drug and Biologics Regulatory Pathways Professional Certificate
36 lessons, about 16 hours. Online and self-paced, with a certificate when you finish.
Regulatory Foundations and Pathways
Learners establish the statutory, organizational, and operational framework for selecting U.S. drug and biologics regulatory pathways and coordinating development activities.
- 1FDA Authority and Regulatory Hierarchy
- 2Drug Development Lifecycle Stage Gates
- 3Drug and Biologic Pathway Classification
- 4Sponsor and CRO Regulatory Operations
Pre-IND Evidence and Planning
Learners assess early-development evidence, participant protections, cross-functional readiness, and emerging FDA initiatives before clinical investigation.
- 5First-in-Human Evidence and Manufacturing Readiness
- 6Clinical Protocol and Participant Protection Review
- 7Integrated Regulatory Development Milestone Plan
- 8Expedited IND Pilot Eligibility Assessment
IND Filing and Maintenance
Learners organize IND submissions, assess authorization to begin studies, classify safety reports, maintain investigational applications, and document sponsor oversight.
- 9IND Submission Content and Forms
- 10IND Effectiveness and Clinical Hold Decisions
- 11IND Safety Case Classification
- 12Electronic IND Safety Report Routing
- 13IND Amendments and Annual Reports
- 14Sponsor Oversight and IND Readiness Audit
FDA Meetings and Feedback
Learners select appropriate FDA interactions, formulate answerable regulatory questions, prepare supporting evidence, and manage meeting outcomes.
- 15FDA Meeting Types and Eligibility
- 16FDA Meeting Request Development
- 17Evidence-Based FDA Briefing Package
- 18Simulated FDA Meeting Package Practicum
Expedited Regulatory Strategies
Learners assess statutory expedited programs and specialized FDA initiatives, justify eligibility, and build defensible regulatory strategy recommendations.
- 19Fast Track and Breakthrough Therapy
- 20Accelerated Approval and Confirmatory Trials
- 21Priority Review and Specialized Designations
- 22Expedited Regulatory Strategy Recommendation
Marketing Dossiers and Electronic Publishing
Learners structure NDA and BLA submissions, apply current electronic publishing requirements, verify standardized study data, and assemble submission-ready dossiers.
- 23Five-Module Common Technical Document Architecture
- 24NDA and Original BLA Requirements
- 25eCTD Submission and Lifecycle Operations
- 26Electronic Study Data Standards Assessment
- 27Submission Dossier Quality Control
- 28Annotated NDA and BLA Dossier Practicum
FDA Filing and Review
Learners distinguish application filing from approval, calculate PDUFA VII review goals, interpret agency actions, and plan regulatory review resources.
- 29Application Receipt and Filing Assessment
- 30PDUFA VII Review Clock Calculations
- 31FDA Review Milestones and Decisions
- 32Regulatory Review Fees and Timelines
Postapproval Regulatory Operations
Learners classify approved-product changes, manage pharmacovigilance and reporting commitments, and integrate end-to-end regulatory responsibilities into a lifecycle control system.
- 33Postapproval Manufacturing and Labeling Changes
- 34Postmarketing Pharmacovigilance Reporting Operations
- 35Annual Reports and Postmarketing Commitments
- 36Integrated Regulatory Lifecycle Capstone