Executive Development Programme in Nano Health Regulatory Affairs
-- ViewingNowThe Executive Development Programme in Nano Health Regulatory Affairs is a certificate course designed to address the growing demand for experts in the field of nanotechnology and healthcare regulatory affairs. This programme emphasizes the importance of understanding the unique challenges and opportunities in regulating nano health products, an area of increasing significance in the industry.
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⢠Introduction to Nano Health Regulatory Affairs: Understanding the regulatory landscape, challenges, and opportunities in nano health.
⢠Nanotechnology in Healthcare: Basics of nanotechnology, nano-enabled medical devices, and pharmaceutical applications.
⢠Regulatory Frameworks: Overview of global regulatory frameworks governing nano health, such as FDA, EMA, and others.
⢠Regulatory Pathways: Examining the regulatory approval process for nano health products, including pre-market authorization and post-market surveillance.
⢠Safety and Risk Assessment: Strategies for evaluating the safety and risk of nano health products, including toxicology, ecotoxicology, and environmental impact.
⢠Quality Control and Assurance: Implementing quality management systems and good manufacturing practices for nano health products.
⢠Labeling, Packaging, and Storage: Compliance requirements for labeling, packaging, and storage of nano health products.
⢠Clinical Trials and Data Management: Designing and conducting clinical trials for nano health products and managing data accordingly.
⢠Pharmacovigilance and Adverse Event Reporting: Monitoring the safety of nano health products and reporting adverse events.
⢠Ethical, Legal, and Social Considerations: Addressing ethical, legal, and social considerations in nano health regulatory affairs.
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