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Member since October 19, 2016
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I account for more than nine (9) years of scientific and medical writing experience in accordance with ICH-GCP guidelines, client's SOPs, and best publication standards. Part of my past responsibilties included ongoing review and update of EU IMPDs, writing and content-processing of various CTAs in EU, writing and content-processing of various regulatory documents (before- and after marketing approval) for various medicinal products in various indications (e.g. immunology, oncology, urology, gynecology, respiratory medicine, pulmonology, ophthalmology), preparation and writing of safety- and quality reviews / expert statements to be used along with the application package during various regulatory submissions, preparation and content-processing of various essential documents for clinical trials (study protocols, clinical study reports, CTDs, safety reports e.g. PSURs, PBRERs, RMPs, ACOs, aggregate saftey reports), and preparation of responses to safety queries from the Authorities.
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