Pharmacovigilance

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: [email protected]