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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⢠Global Regulatory Landscape: Overview of global biomedical regulatory affairs, including major medical device and pharmaceutical regulatory bodies
⢠Regulatory Strategy for Global Markets: Developing and implementing effective regulatory strategies for global markets, including product classification and pathways to approval
⢠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)
⢠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
⢠Regulatory Affairs in Japan: Understanding the Pharmaceuticals and Medical Devices Agency (PMDA) and its regulatory requirements for medical devices and pharmaceuticals
⢠Regulatory Affairs in Canada: Comprehension of Health Canada and its regulatory processes, including the Medical Device License (MDL) and Drug Identification Number (DIN)
⢠Regulatory Affairs in China: Insight into the National Medical Products Administration (NMPA) and its regulatory requirements for medical devices and pharmaceuticals
⢠Regulatory Affairs in Brazil: Knowledge of the National Health Surveillance Agency (ANVISA) and its regulatory processes for medical devices and pharmaceuticals
⢠Regulatory Affairs in Australia: Familiarity with the Therapeutic Goods Administration (TGA) and its regulatory requirements for medical devices and pharmaceuticals
⢠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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