Trilogy helps our clients’ pharmacovigilance departments identify new safety signals (if present), giving advice on the Marketing Authorisation Holder (MAH) response and communicating the key messages to reviewers in a clear and easy-to-understand manner.Trilogy’s experience extends to more than 100 PSURs across an extensive range of indications.The same PBRER format has also been adopted to replace PADERs in the United States. A new format for PSURs, the PBRER (Periodic Benefit Risk Evaluation Report: ICH E2C (R2)), came into force in the European Union and European Economic Area on 2nd July 2012 – as the result of the European Medicines Agency (EMA) guidance on Good Pharmacovigilance Practices (GVP) issued in June 2012.PSURs are important pharmacovigilance documents applying to drugs already approved for marketing – regularly updating regulatory authorities on the worldwide safety experience of approved drugs.Risk Evaluation and Mitigation Strategies (REMS).Periodic Adverse Drug Experience Report (PADER).Development Safety Update Report (DSUR).120 Day Safety Update (4 Month Safety Update).Investigational Medicinal Product Dossier (IMPD).Special Edition: Medical Writing – A Bold New Path: The Future Awaits Us.Special Edition: Medical Writing: The Backbone of Clinical Development.
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