EONIAN STANZAS, LLC
Summary
regulatory writing, Medical Writing, Grant Writing, publication planning, manuscripts, regulatory submission, clinical training, continuing education, online training, GXP, e-learning, webinars, clinical study reports, patient education, employee education, CMC, scientific consulting, technical writing
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Description
Regulatory writing (pharmaceutical/medical device) in all therapeutic areas (hematology/oncology, reproductive medicine, bone health, orthopedics, dermatology, cardiovascular, neurovascular, urology, infectious disease, rare disease, cancer Immunotherapeutics, vaccines, pharmacogenetics โขManuscripts/reports, regulatory submissions, patient education materials, SOP, consent, protocol, case reports, summary of clinical efficacy/safety, clinical study report, aggregate reports (integrated summary of safety, development safety update report, periodic safety update report, periodic benefit-risk evaluation report, periodic adverse drug experience report), individual safety reports, risk management plan โขSupporting medical component of pharmacovigilance/drug safety activities Developing educational materials/CMEs for health care professionals and patients (webinars, Classroom, e-learning training, e-books) using Criterion-Referenced Instruction (CRI) instructional design
