Related Experiment Video
Updated: Nov 5, 2025
10:17
High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
9.9K
Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities.
Veronique F Kugener1, Eric S Freedland2, Kenneth I Maynard2
1Global Patient Safety Evaluation, Research & Development, Takeda Pharmaceuticals International Co., 300 Massachusetts Avenue, Cambridge, MA, 02139, USA. Veronique.Kugener@Takeda.com.
Drug Safety
|May 16, 2021
Summary
This review shares US pharmacovigilance experiences to improve drug safety globally. It proposes a framework based on scientific excellence, operational efficiency, and knowledge sharing for better global drug safety systems.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Global Health
Background:
- Current pharmacovigilance practices require enhancement for global drug safety.
- The US experience offers valuable insights into improving pharmacovigilance systems.
Purpose of the Study:
- To present US perspectives on enhancing pharmacovigilance.
- To outline opportunities for improving current pharmacovigilance practices.
- To propose a framework for an efficient global pharmacovigilance system.
Main Methods:
- Review of US pharmacovigilance experiences.
- Analysis of current practices and future opportunities.
- Development of a framework based on three key pillars.
Main Results:
- Identified best practices in pharmacovigilance from the US.
- Proposed a three-pillar framework: medical/scientific excellence, operational/compliance excellence, and knowledge sharing/expert development.
- Highlighted the applicability of these concepts worldwide.
Conclusions:
- The proposed framework can guide the establishment of efficient global pharmacovigilance systems.
- Enhancing pharmacovigilance through scientific and operational excellence is crucial for worldwide drug safety.
- Knowledge sharing and expert development are vital components of a successful global pharmacovigilance system.
More Related Videos
Related Concept Videos
01:19Pharmacovigilance
1.3K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.3K
01:25Drug Regulation
2.2K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.2K
01:03Drug Control Governance: Regulatory Bodies and Their Impact
333
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
333
01:26Drug Discovery: Overview
10.2K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
10.2K
01:29Therapeutic Drug Monitoring: Affecting Factors
49
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
49
01:12Analysis of Population Pharmacokinetic Data
509
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
509