Executive Development Programme in Healthcare Product Registration
-- ViewingNowThe Executive Development Programme in Healthcare Product Registration is a certificate course designed to empower professionals with the necessary skills to navigate the complex world of healthcare product registration. This program is critical in today's industry, where regulatory compliance is paramount.
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โข Healthcare Product Regulation Overview: Understanding the regulatory landscape, global vs. regional regulations, and current trends in healthcare product registration
โข Regulatory Affairs Fundamentals: Introduction to regulatory affairs, regulatory strategy, and stakeholder management in healthcare product registration
โข Product Development Lifecycle: Overview of product development, including design control, risk management, and clinical trials in healthcare product registration
โข Quality Management Systems: Exploring quality management systems, Good Manufacturing Practices (GMP), and quality assurance in healthcare product registration
โข Labeling, Packaging, & Promotion: Learning about labeling requirements, package inserts, and promotional materials in healthcare product registration
โข Regulatory Submissions & Approvals: Understanding the regulatory submission process, including documentation, dossiers, and regulatory approval pathways
โข Pharmacovigilance & Post-Marketing Surveillance: Overview of pharmacovigilance, adverse event reporting, and post-marketing surveillance in healthcare product registration
โข Regulatory Compliance & Audits: Learning about regulatory compliance, inspection readiness, and internal/external audits in healthcare product registration
โข Emerging Trends & Challenges: Exploring emerging trends, such as digital health, real-world evidence, and regulatory challenges in healthcare product registration
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