Advanced Certificate in Drug Safety for Medical Devices
-- ViewingNowThe Advanced Certificate in Drug Safety for Medical Devices is a comprehensive course designed to equip learners with critical skills in ensuring drug safety in medical devices. This certification is vital in the highly regulated medical device industry, where drug safety assumes paramount importance.
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⢠Regulatory Framework for Drug Safety in Medical Devices: An in-depth examination of global regulations, guidelines, and standards for drug safety in medical devices, including FDA, EU MDR, and ICH guidelines.
⢠Pharmacovigilance in Medical Devices: Understanding the principles and practices of pharmacovigilance in medical devices, including monitoring, reporting, and evaluating adverse drug reactions.
⢠Drug-Device Combination Products: An exploration of the unique challenges and considerations in ensuring drug safety for drug-device combination products, with case studies and real-world examples.
⢠Chemistry, Manufacturing, and Controls (CMC) for Drug-Device Combination Products: A focus on the CMC aspects of drug-device combination products, including formulation, manufacturing, and quality control.
⢠Risk Assessment and Management in Drug Safety for Medical Devices: Techniques and methodologies for risk assessment and management in drug safety for medical devices, including Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
⢠Clinical Trials and Post-Market Surveillance for Drug Safety in Medical Devices: Best practices for conducting clinical trials and post-market surveillance to ensure drug safety in medical devices, including study design, data analysis, and reporting.
⢠Communication and Collaboration in Drug Safety for Medical Devices: Effective communication and collaboration strategies for stakeholders involved in drug safety for medical devices, including industry, regulators, healthcare providers, and patients.
⢠Emerging Trends and Future Directions in Drug Safety for Medical Devices: An overview of emerging trends and future directions in drug safety for medical devices, including personalized medicine, digital health, and artificial intelligence.
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