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  • AfRIG: Drug Utilization Metrics in Pharmacoepidemiology Research

    Contains 1 Component(s)

    Speakers: Isle Truter, FISPE

    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

    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

    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

    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

    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

    Algorithm, model, methods of COVID-19

    Algorithm, model, methods of COVID-19

  • 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

  • International collaboration on real-world evidence in COVID-19

    Contains 1 Component(s) Recorded On: 11/24/2020

    International collaboration on real-world evidence in COVID-19

    International collaboration on real-world evidence in COVID-19

  • Next Generation Registries: Innovation, Best Practices, and Use Cases

    Contains 1 Component(s)

    Speakers: Rich Gliklich, MD | CEO, OM1 Kathleen Troeger, MPH | Director of Outcomes Research at Hologic, Inc. Michelle Levy, MPH |Head, Healthcare Research and Policy, OM1

    As real world data needs continue to grow, a new paradigm for patient registries is becoming increasingly important in
    answering questions on treatment safety, effectiveness and value. These next generation registries leverage electronic health
    records and other systems to reduce burden, increase enrollment and improve follow-up.
    The latest edition of the Agency for Healthcare Research and Quality's Registries for Evaluating Patient Outcomes: A User's
    Guide (scheduled for publication in August) helps bridge the gap between where registries have been and where they are
    going.
    This webinar will explore:
    - Leveraging electronic health records and other systems in developing registries
    - Using standardized outcome measures
    - Building automated data networks to drive multi-stakeholder needs
    - Leveraging advanced technologies for larger sample sizes and lower burden
    - Harnessing unstructured data
    Learning Objectives
    - Understand new innovations and data quality criteria for registries
    - Apply new technologies and approaches to RWD to registries

    Speakers: 
    Rich Gliklich, MD | CEO, OM1
    Kathleen Troeger, MPH | Director of Outcomes Research at Hologic, Inc.
    Michelle Levy, MPH |Head, Healthcare Research and Policy, OM1

  • Outcomes in patients with COVID-19

    Contains 1 Component(s) Recorded On: 11/06/2020

    Outcomes in patients with COVID-19

    Clinical Outcomes During COVID-19 Hospitalization: A Retrospective Cohort Study Comparing Immunocompromised to Immunocompetent Persons. - Kayte Andersen

    Risk factors for COVID-related death among 27 million U.S. Medicare Beneficiaries. - Hector Izurieta
    Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network- Maria Kempner
    Examining adverse outcomes and monthly trends in pediatric and adult patients with COVID-19: a real world evidence study- Sierra Luciano