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

Stereotype Content Model02:16

Stereotype Content Model

15.4K
The Stereotype Content Model (SCM) was first proposed by Susan Fiske and her colleagues (Fiske, Cuddy, Glick & Xu, 2002; see also Fiske, 2012 and Fiske, 2017). The SCM specifies that when someone encounters a new group, they will stereotype them based on two metrics: warmth—or that group’s perceived intent, and how likely they are to provide help or inflict harm—and competence—or their ability to carry out that objective. Depending on the warmth-competence...
15.4K
Relative Risk01:12

Relative Risk

2.0K
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
2.0K
Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

881
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
881
Quality of Water01:19

Quality of Water

514
In concrete preparation, the quality of water is paramount as it affects the strength and durability of the concrete. Potable water is usually preferred; however, it must not have excessive sodium or potassium to prevent compromising the concrete's integrity. Water quality is typically evaluated based on impurities such as dissolved solids, chlorides, and sulfates, and its pH value is ideally between 6 and 8. Even slightly acidic natural water may be acceptable unless it contains harmful...
514
Quality Control01:05

Quality Control

1.4K
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
1.4K
Quality Assurance01:19

Quality Assurance

1.1K
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
1.1K

You might also read

Related Articles

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

Sort by
Same author

2025 January/February Editorial.

PDA journal of pharmaceutical science and technology·2025
Same author

Evaluation of the Olweus Bullying Prevention Program in US Urban Middle Schools Using a Multiple Baseline Experimental Design.

Prevention science : the official journal of the Society for Prevention Research·2021
Same author

Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap.

PDA journal of pharmaceutical science and technology·2020
Same author

Quality Risk Management-A Role-Based Competency Model.

PDA journal of pharmaceutical science and technology·2020
Same author

Quality Risk Management - A Role-Based Competency Model.

PDA journal of pharmaceutical science and technology·2019
Same author

Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.

PDA journal of pharmaceutical science and technology·2013
Same journal

A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas.

PDA journal of pharmaceutical science and technology·2026
Same journal

Using Positive Controls to Define the Defect Detection Range for CCIT Method Development and Validation.

PDA journal of pharmaceutical science and technology·2026
Same journal

Patient-Centric Drug Delivery: Establishing Injection Hold Time Limits for Large Volume Autoinjectors.

PDA journal of pharmaceutical science and technology·2026
Same journal

Gas flow through micro-capillaries â which flow law is most suitable to predict the flow rate through micro-capillaries?

PDA journal of pharmaceutical science and technology·2026
Same journal

Peer Review.

PDA journal of pharmaceutical science and technology·2026
Same journal

In-situ Verification of Disinfection Rotation for Contamination Control.

PDA journal of pharmaceutical science and technology·2026
See all related articles

Related Experiment Video

Updated: Jan 24, 2026

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

2.5K

Quality Risk Management Competency Model-Case for the Need for QRM Competencies.

Ghada Haddad1, Anne Greene2

  • 1Merck & Co., 770 Sumneytown Pike, West Point, PA 19486; and ghada.haddad@merck.com.

PDA Journal of Pharmaceutical Science and Technology
|May 19, 2019
PubMed
Summary
This summary is machine-generated.

The biopharmaceutical sector needs formal Quality Risk Management (QRM) roles and competencies to fully implement ICH Q9 guidelines. This study surveyed professionals to identify essential QRM roles and their required skills for better risk assessment and patient safety.

Keywords:
Competency ModelsDelphiICH Q10ICH Q9QRM

More Related Videos

Establishing a Competing Risk Regression Nomogram Model for Survival Data
04:57

Establishing a Competing Risk Regression Nomogram Model for Survival Data

Published on: October 23, 2020

10.8K
Vector Competence Analyses on Aedes aegypti Mosquitoes using Zika Virus
10:35

Vector Competence Analyses on Aedes aegypti Mosquitoes using Zika Virus

Published on: May 31, 2020

3.4K

Related Experiment Videos

Last Updated: Jan 24, 2026

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

2.5K
Establishing a Competing Risk Regression Nomogram Model for Survival Data
04:57

Establishing a Competing Risk Regression Nomogram Model for Survival Data

Published on: October 23, 2020

10.8K
Vector Competence Analyses on Aedes aegypti Mosquitoes using Zika Virus
10:35

Vector Competence Analyses on Aedes aegypti Mosquitoes using Zika Virus

Published on: May 31, 2020

3.4K

Area of Science:

  • Pharmaceutical Regulatory Science
  • Quality Risk Management
  • Biopharmaceutical Sector

Background:

  • The ICH Q9 Quality Risk Management (QRM) guideline, published in 2005, has not yet yielded its full benefits in the biopharmaceutical sector.
  • The sector faces challenges in implementing Q9 principles for effective product quality risk assessment and patient safety.
  • A research study identified the necessity for developing QRM role-based competencies to realize QRM's advantages.

Purpose of the Study:

  • To assess the formality of Quality Risk Management (QRM) roles within the biopharmaceutical industry.
  • To explore the need for QRM role-based competencies.
  • To propose initial standard QRM roles and identify associated competencies.

Main Methods:

  • A hybrid Delphi research methodology was employed.
  • Included Survey 1 to gauge the need for QRM role-based competencies.
  • A face-to-face focus group workshop was conducted to propose standard QRM roles.

Main Results:

  • Survey 1 indicated a clear need for QRM role-based competencies.
  • The focus group workshop began proposing initial standard QRM roles.
  • Findings from Survey 1 and the focus group workshop are presented in this paper.

Conclusions:

  • Formalizing Quality Risk Management (QRM) roles is crucial for the biopharmaceutical sector.
  • Developing specific competencies for QRM roles is fundamental to achieving the benefits of QRM.
  • Further research will present competency model development and confirmation of QRM roles.