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This document provides technical guidance on verification and validation aspects of specified design envelope and medical device production systems for personalized medical devices.
Year:
2022
Region / city:
International
Topic:
Medical Devices
Document Type:
Technical Guidance
Organization:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF PMD WG
Target Audience:
Regulatory Authorities, Conformity Assessment Bodies, Industry
Effective Period:
2022
Approval Date:
10 August 2022
Date of Changes:
N/A
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Year:
2025
Region / City:
Gainesville, FL
Subject:
Nursing, Public Health
Document Type:
Course Syllabus
Institution:
University of Florida, College of Nursing
Instructor(s):
Sally Bethart, DNP, APRN, FNP-BC, PHNA-BC, CNE; Marisa Belote, PhD, MBA, RN, CNE
Target Audience:
Nursing Students, RN to BSN Program Participants
Duration:
Fall Semester 2025
Approval Date:
Not specified
Modification Date:
Not specified
Year:
July 2025
Region / City:
Iowa, Des Moines
Topic:
Education, Mathematics Instruction
Document Type:
Model Plan, Technical Assistance
Organ / Institution:
Iowa Department of Education
Author:
McKenzie Snow, Tina Wahlert, Tom Wood, Stefanie Wager, Christi Donald, April Pforts
Target Audience:
Educators, School Administrators
Period of Action:
July 2025 and ongoing
Approval Date:
July 2025
Amendment Date:
None specified
Note:
Year
Document Type:
Research Proposal
Target Audience:
Researchers, Clinicians
Year:
2022
Region / City:
Global
Topic:
Medical Devices, Regulatory Frameworks
Document Type:
Regulatory Guidance
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Personalized Medical Devices Authoring Group
Target Audience:
Medical Device Regulators, Manufacturers, Healthcare Professionals
Period of Validity:
N/A
Approval Date:
10 August 2022
Date of Changes:
N/A
Date:
December 07 - 13, 2013
Region / City:
Moscone Center, San Francisco, USA
Topic:
Environmental Science, Climate Change, Ecosystem Studies
Document Type:
Meeting Schedule
Organizer:
AGU (American Geophysical Union)
Author:
Not specified
Target Audience:
Scientists, Researchers, Conference Attendees
Period of Action:
December 07 - 13, 2013
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Context
Year:
2024
Region / City:
Gainesville, FL
Topic:
Nursing Education, Population Health
Document Type:
Course Syllabus
Institution:
University of Florida, College of Nursing
Author:
Brenda W Dyal, PhD, DNP, APRN, FNP-BC; Reathea Felder, DNP, APRN, FNP-C; Suzanne Weed, DNP, ARNP, FNP-BC, PHC
Target Audience:
Nursing students in the Baccalaureate Program
Period of Effectiveness:
Summer 2024
Approval Date:
N/A
Date of Changes:
N/A
Contextual Description:
A detailed course syllabus outlining objectives, schedule, teaching methods, and evaluation criteria for the nursing course NUR 4636C at the University of Florida.
Document type:
Supplementary online content
Related study:
Personalized Prognostic Prediction of Treatment Outcome for Depressed Patients in a Naturalistic Psychiatric Hospital Setting: A Comparison of Machine Learning Approaches
Setting:
Naturalistic psychiatric hospital setting
Treatment providers:
Psychologists, postdoctoral fellows, clinical psychology interns, psychology practicum students, mental health counselors
Treatment format:
Group treatment
Adherence assessment:
Bi-annual fidelity assessments via live observation and checklists
Adherence rates:
89%–95%
Population:
Depressed patients, including individuals with MDD and comorbid diagnoses
Predictor variables:
Clinical measures, demographic characteristics, MDD history, comorbid diagnoses, treatment history, psychiatric medication use, physical health variables
Outcome measures:
PHQ-9, GAD-7
Statistical methods:
Random Forest imputation (missForest in R), Elastic Net Regression, Lasso, Ridge, Random Forest, Support Vector Machines, Bayesian additive trees, Super Learner, adaptive splines
Validation approach:
10-fold cross-validation and hold-out sample testing
Performance metrics:
Mean Absolute Error (MAE), Mean Squared Error (MSE), R2, squared correlation (r2) with 95% confidence intervals
Year:
2022
Region / City:
Florida
Field:
Nursing
Document Type:
Course Syllabus
Institution:
University of Florida College of Nursing
Authors:
Brooke Russo, PhD, RN, CNE; Bryce Catarelli, DNP, APRN, FNP-C; Michelle Plourde, MSN-Ed, RN, CEN; Sandra Wolfe Citty, PhD, APRN-BC, CNE; Cynthia Figueroa, PhD, ARNP, ANP-BC; Sallie Shipman, EdD, MSN, RN, CNL, NHDP-BC, CNE; Karen Schofield, MSN, RN; Toni Lindsey, DNP, RN, CNE, CPN-BC; Allison Kathleen Peters, DNP, RN, CNOR, CEN; Anita Stephen, PhD, RN, CNL
Target Audience:
Nursing students
Effective Period:
Spring 2022
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2022
Region / City:
Gainesville, FL
Subject:
Nursing
Document Type:
Course Syllabus
Institution:
University of Florida College of Nursing
Author:
Karen Aul, PhD, RN, CNE, CHSE; Allison Peters, DNP, RN, CNOR, NEC; Anne C. Dillard, DNP, RN, AGCNS, CNE; et al.
Target Audience:
Nursing Students
Period of Validity:
Spring 2022
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2020
Region / City:
Not specified
Theme:
Educational intervention, cognitive development, behavioral change
Document type:
Research article
Author:
Dr. Shruti Marwaha, Vijay Singh, Mukesh Boobalan, Sandip Sampatrao Bobade
Target audience:
Educators, researchers, parents
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Keywords:
Confidence, creative quotient, decision making ability, focus factor, intelligence quotient
Year:
2026
Region / City:
United States / House of Representatives
Topic:
Legislative Administration
Document Type:
Resolution
Author:
Committee on Rules and Legislative Administration
Target Audience:
Members of the House of Representatives
Effective Period:
From the date of adoption
Approval Date:
2026
Date of Amendments:
N/A
Year:
2021
Region / City:
Gainesville, FL
Topic:
Nursing Education, Personalized Care
Document Type:
Course Syllabus
Institution:
University of Florida
Author:
Sharon Adams, Bryce Catarelli, Sallie Shipman, Sally Bethart, Michael D. Bumbach, Sandra Wolfe Citty, David Derrico, Ann Dillard, Brian Holland, Shari Huffman, Shavondra Huggins, Sonia Levy-Davis, Toni Lindsey, Michael Maymi, Patrick Nobles, Allison Peters, Veronica Robinson, Brooke S. Russo, Kara Schubart, Anita M. Stephen, Jennifer C. Vendt, Nancy G. Young
Target Audience:
Nursing students
Period of validity:
Fall 2021
Approval Date:
Not specified
Date of Changes:
Not specified
Date:
March 27, 2020
Time:
11:00–12:00 PST
Facilitator:
Laurie Erceg
Topic:
Motivating Students and Personalized Learning for Engagement
Type of document:
Session summary / educational meeting notes
Target audience:
Educators, teachers
Key themes:
Student motivation, personalized learning, life skills integration, online instruction adaptation, hands-on activities
Educational strategies discussed:
Anticipatory thinking, student co-authored lesson plans, RAOK Tree, career pathway skills, civic duty, practical life skills
Supplementary resources:
Online self-assessments, TED talks, Nearpod, recommended books
Mode of delivery:
Virtual session
Summary of session content:
Notes from an educator session detailing strategies, activities, and resources for enhancing student engagement, personalizing lessons, and integrating life skills into virtual and in-person learning environments.
Year of PhD:
2015
Institution:
Jamia Millia Islamia in collaboration with AIIMS, New Delhi, India
Current Position:
Post-Doctoral Associate
Organization:
Center of Personalized Nanomedicine, Institute of NeuroImmune Pharmacology, Florida International University, Miami, Florida, USA
Research Focus:
Development of biodegradable hydrogels, nanogels, injectable hydrogels, and drug delivery systems for Neuro-AIDS
Awards:
Early Career Investigator Travel Award (ECITA), Arthur Falek Early Career Investigator Award
Selected Publications:
Multiple peer-reviewed journals from 2012 to 2016 on hydrogel-based drug delivery systems
Email:
[email protected]
Phone:
+1-305-348-1490
Web:
https://scholar.google.com/citations?user=XuivQWcAAAAJ&hl=en
Profile type:
Academic researcher biography and publication record
Year:
2026
Organization:
Medavie Blue Cross
Document type:
Program announcement
Target audience:
Medavie Blue Cross members
Topic:
Gut health, personalized healthcare
Services included:
Dietitian consultations, advanced microbiome testing
Program components:
Gutcheck, Gutcheck VIVO
Access method:
Connected Care platform
Year:
2004
Region / City:
International
Topic:
Process Validation, Medical Device Manufacturing
Document Type:
Guideline
Organization / Institution:
Philips
Author:
Philips Quality Engineering
Target Audience:
External suppliers, manufacturers of medical devices
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Khyber Pakhtunkhwa
Theme:
Digital Governance, Workflow & Document Management System, Third-Party Validation
Document Type:
Terms of Reference
Organization / Institution:
Khyber Pakhtunkhwa Revenue Mobilization & Public Resource Management Program (KPRMP)
Author:
KPRMP
Target Audience:
Third-Party Firms, IT Consultants, and Government Agencies
Period of Validity:
06 months
Approval Date:
Not specified
Modification Date:
Not specified
Contextual Description:
Terms of Reference for engaging a third-party firm to validate the deliverables submitted by Netsol Technologies in the development of a Workflow & Document Management System for the Khyber Pakhtunkhwa government.
Note:
and the site visit team chair eight (8) weeks prior to the site visit)(4.2024)
Year:
2024
Region / City:
N/A
Theme:
Accreditation
Document Type:
Schedule Template
Organization / Institution:
ARC-PA
Author:
N/A
Target Audience:
Program administrators, Site visit team
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Region / City:
United Kingdom
Topic:
Woodland Carbon Code, Project Validation
Document Type:
Project Design Document (PDD)
Organization / Institution:
UK Land Carbon Registry
Author:
Vicky West
Target Audience:
Project or Group Managers seeking Woodland Carbon Code validation
Period of Action:
Ongoing until project completion
Approval Date:
April 2024
Date of Amendments:
April 2024