Certificate in Pharmaceutical Regulatory Submissions
-- ViewingNowThe Certificate in Pharmaceutical Regulatory Submissions course is a comprehensive program designed to empower learners with the necessary skills to excel in the pharmaceutical industry. This course highlights the importance of regulatory submissions, an essential process that ensures the safety and efficacy of pharmaceutical products.
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โข Introduction to Pharmaceutical Regulatory Submissions: Understanding the regulatory landscape, submission types, and stakeholders.
โข Regulatory Strategy: Developing a regulatory strategy to support product development and lifecycle management.
โข Regulatory Writing: Writing and compiling high-quality regulatory documents, including the Common Technical Document (CTD).
โข Pharmaceutical Quality System (PQS): Implementing and maintaining a PQS to meet regulatory requirements.
โข Clinical Trial Regulations: Navigating regulations for clinical trials, including Investigational New Drug (IND) applications.
โข Marketing Authorization Applications (MAAs): Preparing and submitting MAAs in the European Union and other regions.
โข New Drug Applications (NDAs): Preparing and submitting NDAs in the United States and other regions.
โข Post-Authorization Changes: Managing post-authorization changes, including variations, supplements, and line extensions.
โข Regulatory Intelligence: Gathering and analyzing regulatory intelligence to inform regulatory strategy and decision-making.
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