Practical course on Pharmacovigilance Aggregate reports

Partner: Udemy
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Description: Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development called development safety update reports while Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports/Periodic Benefit-risk Evaluation Reports (PBRERs) are submitted for products with marketing authorization. Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product. PADERs are aggregate safety reports to be submitted to the Food and Drug Administration (FDA) for products approved for marketing in the United States (US). Quality of aggregate reports became a major compliance issue globally due to their complexity and regulatory scrutiny.  This practical training course in writing aggregate reports will help industry professionals to keep up with the regulatory requirements. This training will help to understand the essential aspects of pharmacovigilance medical safety writing as per current regulatory framework. Learning objectives: 1. Will learn about the requirements mentioned in ICH E2C and E2F, good pharmacovigilance practices (GVP module VII), as well as global acceptability. 2. Source data collection, whole process of report preparation and critical aspects of writing, preparing line listings and summary tabulations. 3. In depth knowledge on template of DSUR, PBRER, RMP, and PADER. Who will attend: This course is intended for the professionals working within the pharmaceutical industry In pharmacovigilance, drug safety, regulatory, and medical writing positions. Professionals Most likely to benefit from this training are newcomers to the medical writing and/or Pharmacovigilance positions or writers/specialists with intermediate
Category: Teaching & Academics > Other Teaching & Academics > Pharmacovigilance
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Price: 24.99
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Source: Impact
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