Overview

Pharmacoepidemiology is a scientific discipline that uses epidemiological methods to evaluate the use, benefits and risks of drugs, devices and biologicals. It focuses on observational research methods that use data which are generated in the usual care of patients. This four-course specialization teaches: The drug development process Methods for assessing use of products with real-world data Observational methods for effectiveness evaluation Methods for pharmacovigilance and safety evaluation The course directors provide insights from the field to inform trainees and professionals seeking to improve the quality and safety of medication use. This course is ideally suited for early and mid-career medicine, pharmacy, and public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug safety to inform their work in academic, regulatory, or industry settings.

Syllabus

Course 1: Pillar #1: Drug Development - From Bench to Bedside
Course 2: Pillar #2: Drug Utilization - Drivers and Consequences
Course 3: Pillar #3: Drug Effectiveness - Real-World Evidence
Course 4: Pillar #4: Drug Safety - Pharmacovigilance

Courses

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6 hours 20 minutes
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This course addresses the key principles of research aimed at assessing the effectiveness and safety of pharmaceuticals. We begin by exploring the role of effectiveness research and stakeholders who need this evidence and explore the common observational designs that are used with real world data to generate real world evidence about safety, effectiveness and comparative effectiveness of drugs. We discuss confounders and biases that must be addressed and methods for overcoming these challenges both in the design and in the analysis of observational studies. We briefly address pragmatic trials as a source of effectiveness and safety information. The course concludes with examples of published studies illustrating good practices.
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5 hours 6 minutes
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Have you ever taken over the counter or prescription drug? Are you curious about how these drugs are developed, approved and brought to the market? We begin by providing an overview of drug development and approval process and the role regulatory agencies, such as the US Food and Drug Administration, play in the approval process. We discuss phases of clinical trials – phases 1, 2, 3 and 4 – to evaluate efficacy and safety of drug products, along with case studies. We define pharmacoepidemiology – a scientific discipline to study use, safety and effectiveness of medical products and interventions – and the role it plays throughout the drug life cycle with relevant case studies. We also discuss how pharmacoepidemiology informs regulatory, policy and clinical decisions. Finally, we provide high-level overview of essential tools – study protocols, data sources, study designs and analysis – to conduct pharmacoepidemiologic studies.
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5 hours 12 minutes
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This course provides a comprehensive overview of drug safety and pharmacovigilance. We start with the fundamentals of pharmacovigilance and regulatory requirements, including phase 4 post-marketing safety studies. We discuss passive and active surveillance methods, exploring key surveillance systems in the US and globally. The course concludes with real-world examples, demonstrating how drug safety research impacts regulatory decisions and prescribing practices.
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6 hours 48 minutes
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The determinants of drug utilization are complex and multifactorial, and understanding how, why, when and where drugs are used is crucial to inform regulatory and payment policy and clinical practice. We begin by reviewing methods of investigating drug utilization and evaluating interventions to prescribing. We then explore common challenges to optimizing medicine use, including non-adherence and off-label drug use. We also consider methods to improve the quality of drug utilization, including value-based insurance designs, audit and feedback, patient education and medication therapy management. We also consider varied patient, provider, practice and system-level determinants of prescription drug utilization, including marketing and promotion, emerging evidence of benefits and harms, regulation and changes in coverage and reimbursement. Finally, we use four case studies to reinforce many of the core topics we’ve explored: antibiotics, prescription opioids, anticoagulants and generics and biosimilars.