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Pharmacovigilance

Pharmacovigilance

FromQueens of Quality Podcast


Pharmacovigilance

FromQueens of Quality Podcast

ratings:
Length:
27 minutes
Released:
Aug 24, 2022
Format:
Podcast episode

Description

Pharmacovigilance is the process of monitoring the effects of medical drugs after they have been licensed for use, especially to identify and evaluate previously unreported adverse reactions.Welcome to another incredible episode with your hosts, Jennifer and Michelleanne. In this episode, we focus on pharmacovigilance in the pharmaceutical industry. We talk about who is responsible for drug safety & pharmacovigilance, the sources of pharmacovigilance data, and pharmacovigilance in clinical trials. In addition, we discuss the Investigator’s Brochure (IB) and Adverse Event (AE) reporting policy and share how you can turn pharmacovigilance into a competitive advantage. Tune in! During this episode, you will learn about;[00:01] Episode introduction[00:35] Today’s focus; pharmacovigilance [01:23] Definition of pharmacovigilance[04:20] Who is responsible for drug safety & pharmacovigilance?[05:54] Sources of pharmacovigilance data[08:40] Pharmacovigilance in clinical trials [10:00] Adverse Event (AE) reporting policy[14:33] Investigator’s Brochure (IB)[16:30] Postmarketing surveillance and adverse drug reactions[20:03] A recap of the episode[22:21] Turning pharmacovigilance into a competitive advantage[26:04] How to connect with us Love the show? Follow, Rate, Review, Like, and Share! Let’s Connect!Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com
Released:
Aug 24, 2022
Format:
Podcast episode

Titles in the series (19)

Quality and compliance are often seen as rigid within an organization. Every company has ‘em; nobody wants ‘em, but it’s even more imperative to implement them. Join, Michelleanne and Jen, host of Queens of Quality, the podcast, as they discuss topics in reasonable and, at times, light-hearted delivery. Receive insight on how these requirements can be implemented in a compliant, scale-able, and sustainable manner for organizations at any point within the company life cycle. Every week, we will provide solutions for day-to-day issues to debunk some of the misconceptions about Quality Assurance. Subscribe to the show to stay up to date with new episodes.