Pharmacovigilance has undergone rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with. Our training courses have been designed for drug safety professionals and will offer practical advice on key topics and the latest regulatory developments in this increasingly important field.
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This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.
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Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
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This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
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Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
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A practical guide to understanding the role of pharmacovigilance.
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A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*
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Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
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This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
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This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
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This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
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