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  • Impact of the COVID-19 pandemic on global and local trends in drug supply and utilization

    Contains 1 Component(s)

    Speaker: Katie Suda, Mina Tadrous This session will cover the impact of the pandemic so far using global data from over 70 countries and look to see different policy options available to formulary managers. This information will be vital as the pandemic prolongs and future drug supply shocks. COVID-19, Drug utilization, Mina Tadrous, Katie Suda, pandemic

    Title: Impact of the COVID-19 pandemic on global and local trends in drug supply and utilization
    Speakers: Katie Suda, Mina Tadrous

    Description: This session will cover the impact of the pandemic so far using global data from over 70 countries and look to see different policy options available to formulary managers. This information will be vital as the pandemic prolongs and future drug supply shocks. 

    On March 11, 2020, the World Health Organization (WHO) announced the 2019 novel coronavirus (COVID-19) outbreak as a pandemic. Due to COVID-19, governments implemented interim public health measures to limit the spread of coronavirus disease. Such measures have contributed to a disruption of global supply lines and exposed vulnerabilities in the global pharmaceutical supply chain. 

    Due to the potential serious respiratory effects of COVID-19 on those who are infected, there was also an increase in the global demand for certain drugs used in critical care which led to significant strain and shortage of supply of essential medications. 

  • AfRIG: Pharmacoepidemiology: Relevance in Clinical Practice

    Contains 1 Component(s)

    Speakers: Joseph Fadare AFRIG, Pharmacology, Clinical Practice, Fadare

    Dr. Joseph Olusesan Fadare is an Associate Professor in the Department of Pharmacology and Therapeutics, College of Medicine, Ekiti State University, Ado-Ekiti, Nigeria. He is also a Consultant Physician/Clinical Pharmacologist in associated Ekiti State University Teaching Hospital.

    Dr. Fadare is an alumnus of Varna Medical University, Bulgaria from where he bagged his MD degree. He completed his residency in Internal Medicine (sub-specialty of Clinical Pharmacology and Therapeutics) obtaining the Fellowship of the National Postgraduate Medical College of Nigeria (FMCP). He also holds a joint Master’s degree in Bioethics - Erasmus Mundus Master of Bioethics (specialization Research Ethics) from the Katholieke University (KU), Leuven, Belgium, Radboud University, Nijmegen in the Netherlands, and the University of Padova, Italy. His research interests include pharmacoepidemiology and drug utilization including antimicrobials, antimicrobial stewardship, pharmacovigilance, geriatric pharmacology, drug interactions, clinical trials, and research ethics.

     He has published over 80 peer-reviewed manuscripts and currently serves as an associate editor for Frontiers in Pharmacology. He is a member of several professional societies such as the South African Society for Basic and Clinical Pharmacology, the British Pharmacological Society, the International Society for Pharmacoepidemiology, the American College of Clinical Pharmacology, American Society for Microbiology and Medicines Utilisation Research in Africa group. 

  • The VALORE project: the Italian multi-database network for post-marketing surveillance of biologics and biosimilars

    Contains 1 Component(s)

    The COVID-19 pandemic and the potential role of biologics as either risk factors for SARS-COV-2 infection or as COVID-19 treatments highlighted the importance of setting up a data infrastructure for the rapid generation of real-world evidence (RWE) on biologics in the context of a healthcare emergency. Jessica Jalbert, Gianluca Trifiro,

    Moderator: Jessica Jalbert
    Speaker: Gianluca Trifiro, FISPE

    Description: The COVID-19 pandemic and the potential role of biologics as either risk factors for SARS-COV-2 infection or as COVID-19 treatments highlighted the importance of setting up a data infrastructure for the rapid generation of real-world evidence (RWE) on biologics in the context of a healthcare emergency.

    VALORE is a project funded by the Italian Drug Agency that is aimed at setting up a national network by integrating data from regional claims databases, clinical registries, and prospectively collected data via active surveillance with ultimate goals of: 

    • Assessing prescribing appropriateness and short-/long-term effectiveness and safety of biologics and biosimilars in a real-world setting across therapeutic areas (dermatology, rheumatology, gastroenterology, and onco-hematology);
    • Exploring the interchangeability of reference biologics and biosimilars; 
    • Setting up a national network to generate RWE on biologics that will be used to educate Italian healthcare professiona

  • AfRIG: Drug Utilization Metrics in Pharmacoepidemiology Research

    Contains 1 Component(s)

    Speakers: Isle Truter, FISPE Drug Utilization, Pharmacoepidemiology, DUR, AFRIG

    Ilse Truter is a full professor in the Department of Pharmacy, leader of the Drug Utilization Research Unit (DURU), and Director of the School of Clinical Care & Medicinal Sciences in the Faculty of Health Science at Nelson Mandela University in South Africa. Ilse holds two doctorates (in Pharmacy and Business Management), and is a registered pharmacist and elected member of the South African Pharmacy Council. Ilse has authored 130 peer-reviewed research articles, three chapters in books, and 163 articles in local/professional journals. Her research field is pharmacoepidemiology (including drug utilization research and pharmacoeconomics), clinical pharmacy, and pharmacy management. She is a member of the WHO International Working Group for Drug Statistics Methodology (responsible for the ATC/DDD Methodology), a Fellow of the International Society for Pharmacoepidemiology (ISPE), a founding member of the Medicines Utilisation Research in Africa (MURIA) group, and one of the regional leads for the ISPE African Chapter.

  • AfRIG: Bias and Confounding in Pharmacoepidemiology

    Contains 1 Component(s)

    Speakers: Olaf Klungel AFRIG, Pharmacoepidemiology, Bias and Confounding, Utrecht

    Olaf Klungel is Professor of Pharmacoepidemiologic Methods and head of the division of Pharmacoepidemiology & Clinical Pharmacology. He is also adjunct professor of Pharmacoepidemiology at the University of Southern Denmark in Odense. He was trained as a pharmacist and epidemiologist.

    His main research area is the development, improvement and evaluation of innovative methods of observational drug research. Main applications are in the post-registration phase of drug development. Prof. Klungel represents the division of Pharmacoepidemiology & Clinical Pharmacology in the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP), the IMI-EU2P steering committee (Director of Benefit/Risk Assessment domain) and is PI of the EU Pharmacoepidemiology & Pharmacovigilance Research Network (formerly PROTECT).
    He is President of the International Society for Pharmacoepidemiology (ISPE) and elected steering group member of ENCePP.
    Selected research findings on benefits and harms of medicines include the impact of genetic variants in the renin-angiotensin and salt-sensitivity system on the risk of type 2 diabetes mellitus and myocardial infarction associated with the use of thiazide diuretics and ACE inhibitors, the discovery that thiazide diuretics have a particular beneficial effect compared to other antihypertensive drugs in the prevention of the risk of ischemic stroke (research performed at University of Washington in Seattle, US in collaboration with Prof. Bruce Psaty).
    More recent findings include the increased risk of autoimmune diseases such as rheumatoid arthritis and lupus-like syndrome associated with the use of statins and increased bleeding risk with concurrent use of selective serotonin inhibitors and coumarins.
    In addition to his research, Prof. Klungel teaches pharmacoepidemiology and pharmacotherapy to medical and pharmacy students. He is (co-)author of over 300 papers in peer reviewed journals, book chapters and research reports

  • AfRIG: Measurement of Treatment Effects Using Real World Data

    Contains 1 Component(s)

    Speakers: Jesper Hallas AFRIG, RWE, Measurement of Treatment Effects Using Real World Data

    Jesper Hallas graduated as an MD from the University of Copenhagen in 1984. He has a clinical medicine background as a specialist in internal medicine, medical gastroenterology, and clinical pharmacology.

    Dr. Hallas established the first pharmacoepidemiological prescription database in Denmark, OPED, based on reimbursed prescriptions from Funen County in Denmark (1990 and onwards). Dr. Hallas was one of the co-founders of the Danish Society of Pharmacoepidemiology and became its first president in 1994.

    Since 2004, he has been a professor of clinical pharmacology at the University of Southern Denmark, the first four years also filling a position as consultant in internal medicine at Odense University Hospital.

    Dr. Hallas has been an ISPE member for about 20 years and has served ISPE in several ways, among others, as program chair for the annual meeting in Copenhagen in 2008, as chair of the Public Policy Committee (2011-14) and as president (2017-18)

  • AfRIG: Biostatistical Methods in Pharmacoepidemiology (Part 2)

    Contains 1 Component(s)

    Speakers: Dr. Efe Eworuke AfRIG, Biostatistical Methods in Pharmacoepidemiology (Part 2)

    Dr. Eworuke received her pharmacy degree from the University of Benin, Nigeria in 2005 and completed her master’s degree in Pharmacology from the University of Oxford, United Kingdom in 2008. Shortly afterwards, Dr. Eworuke joined the Department of Pharmaceutical Outcomes and Policy, College of Pharmacy at the University of Florida and completed her PhD in pharmacoepidemiology in 2013. The same year, she joined the FDA’s Division of Epidemiology, Office of Surveillance and Epidemiology as an epidemiologist supporting the regulatory divisions that cover cardiovascular, renal, pulmonary and rheumatology products.

    Currently, Dr. Eworuke is a Master Reviewer Epidemiologist and team lead. As a Master Reviewer, Dr. Eworuke is considered a leading expert on the advanced theories and practices of pharmacoepidemiology and the application of this science in drug safety and regulatory science-related matters. In the team lead position, she oversees epidemiological reviews of study protocols, observational literature, finalized study reports and provides epidemiological recommendations for regulatory decisions. Dr. Eworuke is heavily involved in the design, execution and interpretation of epidemiological studies conducted under the FDA’s Sentinel System. By collaborating with other epidemiologists, statisticians, medical officers, high quality safety evaluations are conducted under FDA’s Active Risk Identification Analysis Systems to support regulatory decisions.

    Outside of the FDA, Dr. Eworuke serves as a clinical affiliate assistant professor for the University of Florida, teaching Data Analysis and Advanced Pharmacoepidemiology courses.

  • AfRIG: Biostatistical Methods in Pharmacoepidemiology (Part 1)

    Contains 1 Component(s)

    Speakers: Dr. Efe Eworuke AfRIG, Biostatistical Methods in Pharmacoepidemiology (Part 1)

    Dr. Eworuke received her pharmacy degree from the University of Benin, Nigeria in 2005 and completed her master’s degree in Pharmacology from the University of Oxford, United Kingdom in 2008. Shortly afterwards, Dr. Eworuke joined the Department of Pharmaceutical Outcomes and Policy, College of Pharmacy at the University of Florida and completed her PhD in pharmacoepidemiology in 2013. The same year, she joined the FDA’s Division of Epidemiology, Office of Surveillance and Epidemiology as an epidemiologist supporting the regulatory divisions that cover cardiovascular, renal, pulmonary and rheumatology products.

    Currently, Dr. Eworuke is a Master Reviewer Epidemiologist and team lead. As a Master Reviewer, Dr. Eworuke is considered a leading expert on the advanced theories and practices of pharmacoepidemiology and the application of this science in drug safety and regulatory science-related matters. In the team lead position, she oversees epidemiological reviews of study protocols, observational literature, finalized study reports and provides epidemiological recommendations for regulatory decisions. Dr. Eworuke is heavily involved in the design, execution and interpretation of epidemiological studies conducted under the FDA’s Sentinel System. By collaborating with other epidemiologists, statisticians, medical officers, high quality safety evaluations are conducted under FDA’s Active Risk Identification Analysis Systems to support regulatory decisions.

    Outside of the FDA, Dr. Eworuke serves as a clinical affiliate assistant professor for the University of Florida, teaching Data Analysis and Advanced Pharmacoepidemiology courses.

  • Algorithm, model, methods of COVID-19

    Contains 1 Component(s) Recorded On: 12/03/2020

    Living systematic benefit-risk assessments for COVID-19 treatments: Establishing a dynamic framework for rapid decision-making Comparing Methodologies to Predict Incidence of COVID-19 in US Counties Validation of claims-based algorithms to identify hospitalized COVID-19 events within the Sentinel System A COVID-19 epidemiologic model to enhance trial efficiency through evidence-based site selection for SARS-COV-2 vaccine trials Miranda Davies, Shimonee Shah, Paul Coplan, Sheryl Kluberg, Debra Schaumberg, ICPE2020

    Living systematic benefit-risk assessments for COVID-19 treatments: Establishing a dynamic framework for rapid decision-making

    We aimed to review both the benefits and the risks for several proposed COVID-19 treatments in severe disease using a living systematic benefit risk assessment based on currently available data, to strengthen the ongoing monitoring of the benefit-risk balance.
    Miranda Davies, Drug Safety Research Unit, Southampton, United Kingdom

    Comparing Methodologies to Predict Incidence of COVID-19 in US Counties

    The spread of SARS-CoV-2 globally led to stringent governmental measures to prevent it. As lockdowns are being eased, models to evaluate potential infection resurgence are important.
    Shimonee Shah/Paul Coplan, Johnson and Johnson, New Brunswick, NJ, USA

    Validation of claims-based algorithms to identify hospitalized COVID-19 events within the Sentinel System

    During the COVID-19 pandemic, observational data provides timely insight into the natural history of the disease, risk factors, and treatments. While claims databases can provide population-based information for COVID-19 research, they often lack access to laboratory results, the gold standard for COVID-19 diagnosis.
    Sheryl Kluberg, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA

    A COVID-19 epidemiologic model to enhance trial efficiency through evidence-based site selection for SARS-COV-2 vaccine trials

    Due to local variability in COVID-19 outbreaks, an epidemiological model capable of predicting intensity of new COVID-19 cases over time at the level of a vaccine trial site’s catchment population is needed to inform site selection.
    Debra Schaumberg, London School of Economics and Political Sciences, Evidera

  • Race, gender, disparities, social isolation, and social distancing of COVID-19

    Contains 1 Component(s) Recorded On: 11/30/2020

    Race, gender, disparities, social isolation, and social distancing of COVID-19

    Race, gender, disparities, social isolation, and social distancing of COVID-19