Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Drug Regulation01:25

Drug Regulation

1.3K
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...
1.3K
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

144
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...
144
Pharmacovigilance01:19

Pharmacovigilance

778
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...
778
Clinical Trials01:16

Clinical Trials

6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
6.6K
Clinical Trials: Overview01:11

Clinical Trials: Overview

2.8K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.8K
Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

5.6K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.6K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Multidimensional Safety Assessment of a Low-Intensity Scanning Ultrasound (SUS) Protocol in Sheep.

Ultrasound in medicine & biology·2026
Same author

Assessing Overall Survival Benefits in Advanced Cancers: The Role of External Comparator Cohort Studies with Real-World Data.

Clinical pharmacology and therapeutics·2026
Same author

An inducible system to study the regulatory functions of GSX2 in human lateral ganglionic eminence-like progenitors.

Developmental biology·2026
Same author

Midwifery Continuity of Care in a Subsequent Pregnancy After Perinatal Loss: A Scoping Review of Qualitative Evidence.

BJOG : an international journal of obstetrics and gynaecology·2025
Same author

Prevalence and Nationality Distribution of Known and Novel Genetic Variants in Children With Primary Ciliary Dyskinesia in the State of Qatar.

Clinical genetics·2025
Same author

Feasibility of ultrasound-mediated blood-brain barrier opening in sheep using sonolucent cranial implants.

Scientific reports·2025

Related Experiment Video

Updated: Jun 9, 2025

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
07:31

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

Published on: May 15, 2020

7.0K

Collaborative Real-World Evidence Among Regulators: Lessons and Perspectives.

Andrew E Beck1, Melissa Kampman1, Cindy Huynh1

  • 1Health Canada, Health Products and Food Branch, Marketed Health Products Directorate, Ottawa, Ontario, Canada.

Clinical Pharmacology and Therapeutics
|October 22, 2024
PubMed
Summary

The International Coalition of Medicines Regulatory Authorities (ICMRA) Working Group enhanced global collaboration for COVID-19 real-world evidence (RWE) and observational studies. Lessons learned will improve future public health emergency research preparedness and response.

More Related Videos

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
11:21

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data

Published on: July 27, 2018

8.2K
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K

Related Experiment Videos

Last Updated: Jun 9, 2025

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
07:31

Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

Published on: May 15, 2020

7.0K
Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
11:21

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data

Published on: July 27, 2018

8.2K
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K

Area of Science:

  • Regulatory Science
  • Public Health
  • Pharmaceutical Policy

Background:

  • The International Coalition of Medicines Regulatory Authorities (ICMRA) unites 38 global regulatory bodies.
  • The COVID-19 pandemic highlighted the need for international collaboration on real-world evidence (RWE) and observational studies.
  • Existing networks and infrastructure were leveraged to address pandemic-related research challenges.

Purpose of the Study:

  • To evaluate the effectiveness of the ICMRA COVID-19 Real-World Evidence (RWE) and Observational Studies Working Group.
  • To identify lessons learned from 3 years of collaborative research during the pandemic.
  • To formulate recommendations for enhancing future public health emergency preparedness and response.

Main Methods:

  • Focused on the ICMRA COVID-19 RWE and Observational Studies Working Group's activities.
  • Conducted a member survey to gather insights and experiences.
  • Analyzed collaborative outputs, including studies and policy statements.

Main Results:

  • The Working Group produced impactful studies and statements on RWE and vaccine safety.
  • Key lessons emphasized the importance of global collaboration, rapid decision-making governance, and network utilization.
  • Recommendations were developed to strengthen international research collaboration and preparedness.

Conclusions:

  • Effective communication, collaborative research, and leveraging infrastructure were crucial to the Working Group's success.
  • The Working Group's experience provides a foundation for future RWE strategic entities.
  • The findings contribute to improving global public health emergency response mechanisms.