Introduction:

Regulatory affairs management ensures that pharmaceutical and biological products comply with quality, safety, efficacy, and regulatory requirements throughout their lifecycle. It encompasses clinical development, product authorization, manufacturing standards, regulatory submissions, and post marketing obligations, including requirements specific to biologics. This training program explores international regulatory frameworks, product classifications, clinical trial requirements, manufacturing compliance, and marketing authorization procedures. It also covers regulatory lifecycle management, pharmacovigilance, inspections, and compliance governance.

Program Objectives:

By the end of this program, participants will be able to:

Analyze regulatory frameworks and product classifications for pharmaceuticals and biologics.
Examine clinical development requirements and regulatory submission pathways.
Evaluate manufacturing standards, quality requirements, and regulatory documentation.
Assess marketing authorization procedures and post-approval regulatory obligations.
Explore pharmacovigilance, regulatory inspections, and compliance governance.

Targeted Audience:

Regulatory Affairs Managers and Specialists.
Pharmaceutical and Biotechnology Professionals.
Quality Assurance and Quality Control Managers.
Clinical Research and Drug Development Professionals.
Pharmacovigilance and Regulatory Compliance Professionals.

Program Outline:

Unit 1:

Regulatory Frameworks and Product Classification:

International pharmaceutical regulatory frameworks and authority responsibilities.
FDA, EMA, and national regulatory requirements.
ICH guidelines and regulatory harmonization.
Pharmaceutical, biologic, and biosimilar classifications.
Regulatory intelligence and market authorization requirements.

Unit 2:

Regulatory Development and Clinical Trial Requirements:

Pharmaceutical and biologic regulatory development pathways.
Nonclinical requirements and Good Laboratory Practice (GLP).
Clinical trial authorizations and Investigational New Drug (IND) provisions.
Good Clinical Practice (GCP) and clinical safety reporting.
Regulatory authority interactions and submission requirements.

Unit 3:

Quality, Manufacturing, and Regulatory Documentation:

Chemistry, Manufacturing, and Controls (CMC) requirements.
Good Manufacturing Practice (GMP) and pharmaceutical quality systems.
Biologic characterization, comparability, and manufacturing consistency.
Process validation, stability, and product specifications.
CTD and eCTD regulatory dossier structures.

Unit 4:

Marketing Authorization and Regulatory Lifecycle Management:

Marketing authorization pathways, including NDAs and BLAs.
Regulatory review procedures and authorization criteria.
Biosimilar authorization and scientific requirements.
Post-approval variations and regulatory change control.
Product labeling, renewals, and authorization maintenance.

Unit 5:

Pharmacovigilance and Regulatory Compliance Governance:

Pharmacovigilance and post-marketing safety surveillance.
Adverse event reporting and safety signal detection.
Risk management plans and REMS requirements.
Regulatory inspections and corrective and preventive action (CAPA) principles.
Data integrity and regulatory compliance oversight.

Regulatory Affairs Management for Pharmaceuticals and Biologics