Certificate in Regulatory Affairs for Drug Development
-- ViewingNowThe Certificate in Regulatory Affairs for Drug Development is a comprehensive course designed to meet the growing industry demand for professionals with a deep understanding of drug development regulatory processes. This program equips learners with essential skills required to navigate complex regulatory landscapes, ensuring compliance and accelerating time-to-market for new drugs.
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GBP £ 140
GBP £ 202
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โข Introduction to Regulatory Affairs: Overview of regulatory affairs, its role in drug development, and the regulatory landscape
โข Drug Development Process: Phases of drug development, clinical trials, and the regulatory implications at each stage
โข Regulatory Strategy: Developing a regulatory strategy to align with business objectives, product development plans, and regulatory requirements
โข Regulatory Submissions: Preparing, submitting, and maintaining regulatory submissions for drug development and approval
โข Pharmacovigilance: Monitoring and reporting adverse events and drug safety data to regulatory authorities
โข Labeling and Packaging: Regulatory requirements for drug labeling and packaging, including content, format, and review processes
โข Quality Assurance and Control: Ensuring compliance with regulatory requirements for quality systems, documentation, and change management
โข Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits, including responses to inspection observations
โข Lifecycle Management: Managing the regulatory lifecycle of a drug, including post-approval changes, line extensions, and product discontinuation
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