Global Certificate in Drug Development Safeguards
-- ViewingNowThe Global Certificate in Drug Development Safeguards course is a comprehensive program that equips learners with crucial skills necessary for success in the pharmaceutical industry. This course emphasizes the importance of upholding ethical standards, ensuring data integrity, and maintaining regulatory compliance during drug development.
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โข Drug Development Process: Overview of the drug development process, including drug discovery, preclinical testing, clinical trials, and regulatory approval & post-marketing surveillance.
โข Regulatory Frameworks: Introduction to global regulatory frameworks for drug development, including FDA, EMA, and ICH guidelines.
โข Clinical Trial Design: Best practices for designing and implementing clinical trials, including randomization, blinding, and statistical analysis.
โข Data Management & Integrity: Strategies for ensuring data integrity and managing data throughout the drug development process.
โข Pharmacovigilance: Overview of pharmacovigilance, including adverse event reporting, signal detection, and risk management.
โข Quality Assurance & Control: Principles of quality assurance and control in drug development, including GxP regulations and compliance.
โข Intellectual Property & Commercialization: Overview of intellectual property protection and commercialization strategies for drug development.
โข Ethics in Drug Development: Discussion of ethical considerations in drug development, including informed consent, patient privacy, and research integrity.
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