Professional Certificate in Drug Safety & Medical Writing
-- ViewingNowThe Professional Certificate in Drug Safety & Medical Writing is a comprehensive course designed to equip learners with critical skills in drug safety and medical communications. This program emphasizes the importance of accurate, ethical, and engaging medical writing, which is essential in the pharmaceutical industry.
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GBP £ 140
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โข Introduction to Drug Safety & Medical Writing: Understanding the fundamentals of drug safety and medical writing, including key terminology, regulatory requirements, and the role of medical writers in drug development.
โข Pharmacovigilance: An in-depth look at pharmacovigilance, including adverse event reporting, signal detection, risk management, and benefit-risk assessment.
โข Regulatory Affairs: Exploring the regulatory landscape for drug development, including regulatory submission requirements, labeling, and post-marketing surveillance.
โข Medical Writing Techniques: Mastering medical writing techniques, including style, tone, and structure, as well as document design and formatting.
โข Clinical Study Reports: Learning how to write and structure clinical study reports, including protocols, case report forms, and statistical analysis plans.
โข Periodic Safety Update Reports: Understanding the requirements for writing and submitting periodic safety update reports, including aggregate safety reports and periodic benefit-risk evaluation reports.
โข Medical Communications: Exploring medical communications, including medical affairs, medical information, and medical education, and how medical writers contribute to these areas.
โข Drug Safety in Special Populations: Examining drug safety in special populations, including pediatrics, geriatrics, pregnant women, and patients with rare diseases.
โข Medical Writing Tools & Software: Learning about medical writing tools and software, including reference management, document management, and version control systems.
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