Executive Development Programme in Pharmaceutical Regulatory Writing
-- ViewingNowThe Executive Development Programme in Pharmaceutical Regulatory Writing is a certificate course designed to meet the growing industry demand for skilled regulatory writers. This programme emphasizes the importance of clear, concise, and compliant regulatory writing in the pharmaceutical industry.
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⢠Introduction to Pharmaceutical Regulatory Writing: Understanding the regulatory landscape, types of regulatory documents, and their importance in pharmaceutical industry.
⢠Regulatory Writing Guidelines: Overview of ICH, FDA, and EMA guidelines for regulatory writing.
⢠Clinical Study Reports: Writing and structuring clinical study reports, including analysis and interpretation of data.
⢠Common Technical Document (CTD): Overview and compilation of CTD modules, focusing on quality, nonclinical, and clinical modules.
⢠Periodic Safety Update Reports (PSURs): Writing and compiling PSURs, including safety data analysis and reporting.
⢠Labeling and Package Inserts: Understanding the requirements, writing, and reviewing labeling and package inserts.
⢠Regulatory Submissions: Preparing and submitting regulatory documents to FDA, EMA, and other regulatory agencies.
⢠Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits.
⢠Pharmacovigilance and Risk Management: Understanding and implementing pharmacovigilance and risk management strategies in regulatory writing.
⢠Ethics and Compliance in Regulatory Writing: Ethical considerations, compliance requirements, and best practices in regulatory writing.
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