Program Overview

This certification program provides regulatory professionals with comprehensive knowledge of the planning, preparation, submission, review, and lifecycle management of Biologics License Applications (BLAs) submitted to the U.S. Food and Drug Administration (FDA). The program covers applicable statutes, regulations, guidance documents, eCTD format requirements, Chemistry, Manufacturing, and Controls (CMC) , nonclinical and clinical data requirements, FDA review processes, inspection readiness, and post-approval obligations.

Program Scope

This program encompasses the complete regulatory framework governing biologics from initial discovery through post-approval lifecycle management. Participants will learn the legal and statutory basis for BLAs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. The program covers the full eCTD submission structure from Module 1 through Module 5, including administrative information, quality summaries, CMC data for drug substance and drug product, nonclinical study reports, and clinical study reports. Additional focus areas include facility inspections, pre-license inspections, process validation, stability programs, viral safety, immunogenicity, clinical pharmacology, biostatistics, and post-approval change management. Special regulatory programs such as accelerated approval, breakthrough therapy designation, orphan designation, and pediatric requirements are also addressed.

• Regulatory foundation: PHS Act, FD&C Act, 21 CFR Parts 600, 601, 610, 210, 211
• Development lifecycle: Discovery research through post-approval
• eCTD submission: Modules 1 through 5 structure and content
• CMC: Drug substance, drug product, process validation, stability, viral safety
• Nonclinical studies: Pharmacology, toxicology, pharmacokinetics, immunogenicity
• Clinical studies: Phase 1-3 design, safety, efficacy, biostatistics
• FDA review process: Filing, mid-cycle, late-cycle, advisory committee
• Inspections: Pre-license, facility, inspection readiness
• Post-approval: Supplements, annual reports, post-marketing requirements, change control
• Special programs: Accelerated approval, breakthrough therapy, orphan designation, pediatric studies

Program Objectives

Upon completion, participants will be able to:

• Explain the legal and regulatory basis for BLAs under the PHS Act and FD&C Act
• Determine BLA applicability for various biological product classes
• Navigate 21 CFR Parts 600, 601, 610, 210, 211, and 312
• Prepare eCTD submissions compliant with Module 1 through Module 5 requirements
• Develop CMC sections including drug substance, drug product, and stability
• Integrate nonclinical and clinical data into Module 2 summaries
• Manage FDA interactions during the review cycle
• Support pre-license inspections and facility inspections
• Implement post-approval compliance and lifecycle management
• Lead multidisciplinary BLA submission teams

Target Audience

This program is designed for professionals who work in or support the biological product industry. The curriculum is relevant for individuals responsible for regulatory strategy, submission preparation, quality assurance, manufacturing, clinical development, and nonclinical safety assessment. Professionals seeking to enhance their understanding of FDA requirements for biologics licensing will find the program valuable regardless of their prior regulatory experience level. The content is structured to accommodate both early-career professionals and experienced regulatory affairs specialists.

• Regulatory Affairs Professionals
• CMC Scientists and Technical Writers
• Quality Assurance and Quality Control Personnel
• Manufacturing Personnel (bioprocess, fill/finish, quality operations)
• Clinical Development Teams (physicians, clinical scientists, project managers)
• Nonclinical Scientists (pharmacology, toxicology, pharmacokinetics)
• Pharmacovigilance Professionals
• Regulatory Project Managers
• Medical Writers
• Biotechnology Executives
• Regulatory Consultants
• Auditors and Inspectors

Certification Requirements

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.