Global Certificate in Biomedical Regulatory Affairs for Global Markets
-- ViewingNowThe Global Certificate in Biomedical Regulatory Affairs for Global Markets is a comprehensive course that equips learners with essential skills for navigating the complex world of biomedical regulatory affairs. This course is crucial in an industry where staying up-to-date with regulations and policies is paramount for success.
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โข Global Regulatory Landscape: Overview of global biomedical regulatory affairs, including major medical device and pharmaceutical regulatory bodies
โข Regulatory Strategy for Global Markets: Developing and implementing effective regulatory strategies for global markets, including product classification and pathways to approval
โข Regulatory Affairs in the US: Detailed review of the US Food and Drug Administration (FDA) and its regulatory processes, including premarket approval (PMA), 510(k) clearance, and quality system regulation (QSR)
โข Regulatory Affairs in the EU: Overview of the European Medicines Agency (EMA) and its regulatory processes, including the centralized procedure, mutual recognition procedure, and decentralized procedure
โข Regulatory Affairs in Japan: Understanding the Pharmaceuticals and Medical Devices Agency (PMDA) and its regulatory requirements for medical devices and pharmaceuticals
โข Regulatory Affairs in Canada: Comprehension of Health Canada and its regulatory processes, including the Medical Device License (MDL) and Drug Identification Number (DIN)
โข Regulatory Affairs in China: Insight into the National Medical Products Administration (NMPA) and its regulatory requirements for medical devices and pharmaceuticals
โข Regulatory Affairs in Brazil: Knowledge of the National Health Surveillance Agency (ANVISA) and its regulatory processes for medical devices and pharmaceuticals
โข Regulatory Affairs in Australia: Familiarity with the Therapeutic Goods Administration (TGA) and its regulatory requirements for medical devices and pharmaceuticals
โข Global Clinical Trials and Post-Market Surveillance: Understanding the regulations and requirements for global clinical trials and post-market surveillance, including international harmonization efforts and adverse event reporting
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