PPT-Pharmacovigilance in Clinical Trials

Version 04 Feb 2021 In this training course you will learn What is pharmacovigilance What is the pharmacovigilance responsibility of the investigator in a clinical trial What is the pharmacovigilance responsibility of the sponsor in a clinical trial. New challenges for WHO. Dr Shanthi Pal. . Group Lead, Medicines Safety . . Director/EMP . K. De . Joncheere. Coordinator PAU. G. Forte. Head/RHT. L.Rago. Coordinator/PHI. M Zafar. Coordinator /PQT. New challenges for WHO. Dr Shanthi Pal. . Group Lead, Medicines Safety . . Director/EMP . K. De . Joncheere. Coordinator PAU. G. Forte. Head/RHT. L.Rago. Coordinator/PHI. M Zafar. Coordinator /PQT. Protocol=study plan which details what researchers will do in the study. It describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. . JAMASOFT2017. 1. Social. Pharmacy. Pharmacoepidemiology. Pharmacovigilance. JAMASOFT2017. 2. P. armacovigilance. system collects data . throughout the . lifecycle . of each . medicinal. . product. Module 10:. Pharmacovigilance. Background – definitions. Timeline of pharmacovigilance for a drug from development (pre-market) to post-marketing use. Burden of adverse drug reactions in children. Number of pharmacoepidemiological safety studies in children (Osokogu et al, 2016). , MD. Pfizer, India. DISCLAIMER. Overview. Introduction & Terminology. Why Pharmacovigilance?. Pharmacovigilance Practices. : International & Indian. PVPI. Drug Safety Issues in Clinical Trials . Towards EDCTP2. 22 July 2014. Melbourne, Australia. Ole F. Olesen, Ph.D., HD. Director of North-North Cooperation,. EDCTP, The Netherlands. Justification for EDCTP2. Objectives. C. linical . development of effective, safe, accessible, suitable and affordable medical interventions for poverty related and neglected . & . Adverse Drug Reactions . Reporting systems. Dr. . Habab. Khalid . Elkheir. B.Pharm. ., . M.Pharm. ., PhD . ISOP. ISPE. IUATLD. SSCP. 11/28/2017. Habab khalid Elkheir. Objectives of the workshop. Monitoring the safety of medicines. Pharmacovigilance is the science and practices related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. Dr Shanthi Pal. . Group Lead, Medicines Safety . . Director/EMP . K. De . Joncheere. Coordinator PAU. G. Forte. Head/RHT. L.Rago. Coordinator/PHI. M Zafar. Coordinator /PQT. Coordinator RSS. N Dellepiane. Prospects and Challenges of Providing Pharmacovigilance Services in Resource Limited Countries Avong YK 1 , Jatau B 1 , Ekong E 1 , Ndembi N 1 , Okuma J 1 , Obieze AI 2 , Osakwe A 2 , ARVs: Focus on Toxicity Monitoring . and Surveillance of DTG during pregnancy to inform treatment policy . Adele Schwartz Benzaken. . Department . of . STI, . HIV/AIDS . and Viral . Hepatitis. Ministry . Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . No medicine is without . risk and the.  . benefits of . a medicine must always be weighed up against its risks. . The . balance of benefits and risks should be effectively considered and must not be left to chance.