Search for tag: "fda"

15 Media

03:04:07 Winn CDA Cohort 2 Scholars Forum #4 1/18/23 Winn CDA Cohort 2 Scholars Forum #4 1/18/23	Winn CDA Cohort 2 Scholars Forum #4 1/18/23 Winn CDA Cohort 2 Scholars Forum Topic: Regulatory Issues in Clinical Research Date: 1/18/23 Presenter: Vicki Sallée, PhD, MS, RDChief Compliance Officer-Cancer Clinical ResearchDirector,… clinical trials winncda winncdacohort2 engagement patients medicine doctors clinicaltrialist trials drthings disparities careerdiversity faculty things lot tuskegee studies study consent henrietta population trial government syphilis cancer dr fda questions cells guatemala From Nicholette Espinosa 13 plays 0
47:22 Central VA SOCRA Chapter - Investigator Initiated… Central VA SOCRA Chapter - Investigator Initiated Trials: When You Are The Sponsor	Central VA SOCRA Chapter - Investigator Initiated Trials: When You Are The Sponsor This Central VA SOCRA Chapter meeting was recorded September 21, 2022. Monique Williams MPH, CCRC, Assistant Director Early Phase Development Department, Clinical Trials Office, Massey Cancer Center,… investigator sponsor trials ind protocol fda trial study drug patients regulations responsibilities investigation ide From VCU CCTRSOCRA 36 plays
01:19:22 CReSS Workshop: AEs & SAEs: Roadmap to Success CReSS Workshop: AEs & SAEs: Roadmap to Success	CReSS Workshop: AEs & SAEs: Roadmap to Success This Clinical Research Skills Series workshop recorded September 12, 2022, Shirley Helm MS, CCRP, Senior Administrator, Wright Center, Virginia Commonwealth University and Katie Rea RN, MSCR, CCRC,… event drug study events protocol hospitalization participant severity fda investigator criteria severe adverse event adverse event patients From VCU CCTRTWDP 28 plays
01:39:15 1.7.22 Winn CDA Scholars Forum Pt. 2 1.7.22 Winn CDA Scholars Forum Pt. 2	1.7.22 Winn CDA Scholars Forum Pt. 2 1.7.22 Winn CDA Scholars Forum Pt. 2 winn cda things consent henrietta fda patients government lot studies study cells cancer trials question populations nuremberg trial subjects safety dr thing From Aria Albritton 1 plays 0
01:02:18 12.17.21 Winn CDA Scholars Forum Pt. 1 12.17.21 Winn CDA Scholars Forum Pt. 1	12.17.21 Winn CDA Scholars Forum Pt. 1 12.17.21 Winn CDA Scholars Forum winn cda things irb subjects trial patients groups lot ind trials cancer drug investigator patient phase fda areas interests investigators process event From Aria Albritton 4 plays 0
02:55:21 4.1.22 Winn CDA Scholars Forum 4.1.22 Winn CDA Scholars Forum	4.1.22 Winn CDA Scholars Forum 4.1.22 Winn CDA Scholars Forum winn cda patient study fda questions control analysis question placebo model committee treatment bid trial tid patients alright size drug meeting hydroxychloroquine From Aria Albritton 14 plays 0
01:59:57 220429 - PHAR 621 Pharmacoeconomics 220429 - PHAR 621 Pharmacoeconomics	220429 - PHAR 621 Pharmacoeconomics p1 sop pharmacy pharmacoeconomics drug patient disease lot things drugs approval studies patients thing phase evidence reimbursement point countries blood safety diseases cost fda From VCU PHARCAPTURE 1 plays 0
01:11:28 CReSS Workshop: Clinical Study Audits: Know the… CReSS Workshop: Clinical Study Audits: Know the Facts - Be Prepared	CReSS Workshop: Clinical Study Audits: Know the Facts - Be Prepared This Clinical Research Skills Series workshop recorded March 17, 2022, Lauren Kanigher VCU FDA Program Manager discussed the importance of audits and auditors and presents case scenarios to… fda audit irb investigator sponsor presentation auditor ada From VCU CCTRTWDP 32 plays
54:06 Central VA SOCRA Chapter: Hot Topics From The… Central VA SOCRA Chapter: Hot Topics From The Annual 2021 SOCRA Conference	Central VA SOCRA Chapter: Hot Topics From The Annual 2021 SOCRA Conference Shirley Helm, MS, CCRP and Catherine Brown, CCRP from the VCU Wright Center presented and discussed selected sessions from the Annual 2021 SOCRA conference. SOCRA irb investigations studies fda cfr socra annual conference socra clinical research clinical research compliance From VCU CCTRSOCRA 18 plays
01:16:01 TRIPN 8/2021: Bob Dworkin, PhD TRIPN 8/2021: Bob Dworkin, PhD	TRIPN 8/2021: Bob Dworkin, PhD A difference is a difference only if it makes a difference: determining meaningful benefits and risks in pain treatmentAugust 26, 2021 TRIPN Research Meeting Robert H. Dworkin, PhDProfessor of… pain neuropathy tripn translational research patients treatment trials trial placebo benefit lot slide kind fda question difference patient treatments scale safety effect article risk From Teri Dulong-Rae 0 plays 0
01:17:58 Bench to Community Seminar - Series 1, Session 6:… Bench to Community Seminar - Series 1, Session 6: Utilizing VCU Library Resources for Medical Innovation	Bench to Community Seminar - Series 1, Session 6: Utilizing VCU Library Resources for Medical Innovation Session 6 will provide an overview of VCU Libraries resources, services, and faculty available to support ideation and testing of medical innovations.Educational Objectives: Attendees will be able to… institute for engineering and medicine ovpri vcu libraries office of research and innovation innovation ideation medical device development product development medical equipment pharmaceuticals translational research commercialization community engaged research regulatory requirements intellectual property drugs devices investigational medical devices investigational device exemptions library lot things process device question market database resources standards literature vcu questions librarian kind patent databases access reports fda From Laura Osborne 4 plays 0
01:22:26 Bench to Community Seminar - Series 1, Session 5:… Bench to Community Seminar - Series 1, Session 5: FDA Regulatory Pathways and Requirements	Bench to Community Seminar - Series 1, Session 5: FDA Regulatory Pathways and Requirements This session will provide an overview of regulatory approval and commercialization issues impacting companies developing medical devices, drugs, and biologic products. Attendees will be able to… institute for engineering and medicine office of research and innovation ovpri regulatory requirements intellectual property product development product planning innovation iteration medical device development medical equipment medical device commercialization translational research community engaged research project funding biologics funding marketing strategy device fda class lot drug devices things market application trials safety sort idea questions companies question process combination drugs quality From Laura Osborne 8 plays 0 Data Classification CATEGORY I DATA
01:17:35 Bench to Community Seminar - Series 1, Session 2:… Bench to Community Seminar - Series 1, Session 2: Medical Device Development Processes	Bench to Community Seminar - Series 1, Session 2: Medical Device Development Processes Session 2 in this seminar series provides an overview of engineering design and development for medical devices. Viewers will gain insight into the key steps from need definition to product… medical device development fda wright center institute for engineering and medicine ovpri research and development product development product planning office of research and innovation innovation innovation gateway design and development translational research things patient idea engineering device process manufacturing standards lot cost team function concept evaluation prototype market devices class 3d From Laura Osborne 27 plays 0 Data Classification CATEGORY I DATA
01:15:39 Bench to Community Seminar - Series 1 , Session… Bench to Community Seminar - Series 1 , Session 1: Introduction - Translating New Ideas Into Clinical Practice	Bench to Community Seminar - Series 1 , Session 1: Introduction - Translating New Ideas Into Clinical Practice This course introduces the multiple factors involved in translating new solutions for unmet needs into clinical practice reality. The session provides an overview of the process of innovation from… prototyping patent patent process translational research commercialization office of research and innovation institute for engineering and medicine wright center development process product development startup funding b2c bench to community inventions invention disclosure regulatory requirements medical device medical device development market things invention innovation device process industry companies vcu devices programs thing tech lot fda idea engineering From Laura Osborne 30 plays 0 Data Classification CATEGORY I DATA
37:21 CReSS Workshop: Corrective and Preventive Action… CReSS Workshop: Corrective and Preventive Action (CAPA): What is it and when to use it?	CReSS Workshop: Corrective and Preventive Action (CAPA): What is it and when to use it? In this Clinical Research Skills Series workshop recorded August 5, 2020, Terry Smolenski, VCU Massey Cancer Center’s director of regulatory and compliance, discusses the definition of a… consent quality analysis actions capa correction action preventive action clinical research compliance root cause analysis fda clinical trials massey cancer center protocols action plan training training log From Catherine Brown 75 plays 0 Data Classification CATEGORY I DATA