Professional Certificate in Biologics Regulatory Affairs
-- ViewingNowThe Professional Certificate in Biologics Regulatory Affairs is a comprehensive course that equips learners with the essential skills needed to thrive in the rapidly growing biologics industry. This program emphasizes the importance of regulatory affairs in bringing safe and effective biologic products to market, making it highly relevant for professionals in pharmaceutical, biotechnology, and medical device companies.
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Here are the essential units for a Professional Certificate in Biologics Regulatory Affairs:
• Introduction to Biologics Regulatory Affairs: This unit covers the fundamental concepts and regulatory framework for biologics, including the regulatory pathways for approval.
• Biologics Development and Manufacturing: This unit explores the development and manufacturing processes for biologics, including quality control and assurance, and current Good Manufacturing Practices (cGMPs).
• Biologics Labeling and Packaging: This unit covers the requirements for labeling and packaging of biologics, including the content and format of labeling, and the regulatory requirements for packaging.
• Biologics Clinical Trials: This unit examines the clinical trial process for biologics, including the design, conduct, and reporting of clinical trials, and the regulatory requirements for clinical trial applications.
• Biologics Post-Marketing Surveillance: This unit explores the post-marketing surveillance requirements for biologics, including pharmacovigilance, risk management, and signal detection and management.
• Biologics Import and Export Regulations: This unit covers the regulations for import and export of biologics, including the requirements for import/export licenses, and the documentation and reporting requirements.
• Biologics Quality Systems: This unit examines the quality systems required for biologics, including quality management systems, document management systems, and change control.
• Biologics Regulatory Inspections and Audits: This unit explores the regulatory inspections and audits for biologics, including the preparation for inspections, the inspection process, and the follow-up actions required after inspections.
• Biologics Regulatory Submissions: This unit covers the regulatory submissions required for biologics, including the
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