№ files_lp_3_process_7_057568
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Form to be used by investigators in the Department of Veterans Affairs to document investigational drug information, ensuring compliance with regulatory standards for clinical research involving investigational drugs.
Year:
1997
Region / City:
Ann Arbor, MI
Theme:
Investigational drugs in clinical research
Document Type:
Form
Organization / Institution:
Department of Veterans Affairs
Author:
Not specified
Target Audience:
Researchers and investigators in clinical studies
Action Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
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Education and Training:
University of North Carolina at Chapel Hill, UNC Eshelman School of Pharmacy, Doctor of Philosophy (PhD) May 2013; Rutgers, The State University of New Jersey, Ernest Mario School of Pharmacy, Doctor of Pharmacy (PharmD) May 2008 (Summa Cum Laude)
Licensure:
New Jersey (License #28RI03227100, Active), North Carolina (License #20495, Inactive)
Professional Experience and Academic Appointments:
Associate Professor, Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, Michigan, September 2023-Present; Assistant Professor, Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, Michigan, April 2016-Present; Core Member, University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, February 2014-present; Research Assistant Professor, Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, Michigan, April 2013-April 2016
Publications:
Peer-reviewed Publications, e.g., "Supportive Care 2030 Movement: Towards Unifying Ambitions for Global Excellence in Supportive Cancer Care" published in eClinicalMedicine (The Lancet)
Role:
Critical Review
Note:
en
Year:
2024
Region / City:
Ann Arbor, MI
Theme:
Clinical Pharmacy, Pharmacology
Document Type:
Professional Curriculum Vitae
Institution:
University of Michigan College of Pharmacy
Author:
Daniel L. Hertz, PharmD, PhD
Target Audience:
Academic/Medical professionals
Date of Publication:
2024
Date of Update:
2024
Year:
2018
Organization:
VA Ann Arbor Healthcare System
Location:
Ann Arbor, Michigan, United States
Document type:
Medical center policy
Policy number:
MCP S-04
Subject:
Occupational exposure to bloodborne pathogens
Effective date:
September 7, 2023
Recertification date:
September 7, 2028
Responsible office:
Chief Safety Service
Signatory authority:
Medical Center Director
Authorizing official:
Ginny L. Creasman, Pharm.D., FACHE
Regulatory references:
OSHA Bloodborne Pathogens Standard; VHA Handbook 1004.01; U.S. Public Health Service guidelines
Target audience:
Employees with potential occupational exposure to blood or hazardous body fluids
Scope:
Clinical, laboratory, research, and support staff
Period of applicability:
Ongoing with annual review
Year:
2020/2021
Organization:
Ann Arbor Amateur Hockey Association (AAAHA)
Related Facilities:
Ice Cube; Yost
Document Type:
Liability Release Waiver
Subject:
COVID-19 liability and risk acknowledgment
Applicable Activities:
AAAHA events and sanctioned activities
Season:
2020/2021 hockey season
Legal Scope:
Release, waiver, indemnification, and hold harmless agreement
Parties Released:
AAAHA board members, officers, agents, contractors, affiliates, employees, successors and assigns
Signatory Requirement:
Adult participant or parent/legal guardian of minor skater
Minimum Age for Signatory:
18 years
Effective Period:
Until COVID-19 laws and mandates are lifted
Year:
2026
Institution:
University of Michigan, Ann Arbor
Organization:
Alpha Epsilon Phi Sorority, Pi Chapter
Document type:
By-Laws
Purpose:
Establish governance, membership criteria, and operational procedures of the chapter
Target audience:
Chapter members and potential new members
Membership criteria:
Minimum GPA 2.5, no prior bids with other Panhellenic organizations in the last year
Governing body:
Executive Board of eleven active members
Key roles:
President, Vice President Operations, Vice President Finance, Vice President Programming, Vice President Social Standards, Vice President Social Responsibility, Vice President Recruitment, Vice President New Member Education, Vice President Philanthropy, Vice President Sisterhood, Vice President Panhellenic
Recruitment:
Formal Recruitment and Continuous Open Bidding according to Michigan Panhellenic Association policies
Compliance:
National Sorority Constitution and By-Laws, University of Michigan policies
Year:
2019
Region / City:
Ann Arbor, MI, USA
Subject:
Installation of Automatic Door Systems
Document Type:
Government Contract / Solicitation Form
Agency:
Department of Veterans Affairs, Veterans Health Administration
Author / Issuer:
Jeremy Boston, Contracting Officer
Target Audience:
Contractors for commercial item procurement
Effective Period:
Upon award until completion of installation
Award Amount:
$15,000,000
Delivery Location:
VA Ann Arbor Healthcare System, 215 Fuller Road, Ann Arbor, MI 48105
Submission Deadline:
April 30, 2019, 3:00 PM EST
Contracting Method:
RFQ
NAICS Code:
238290
Payment Terms:
Net 30
Scope:
Removal of old manual doors and installation of four automatic powered door systems in the Ambulatory Care Clinic
Technical Contact:
[email protected]
Source Type:
Government solicitation and contract document
Year:
2012
Country:
United States
Region / City:
Ann Arbor, Michigan
Subject:
Research animal care and laboratory animal support services
Document type:
FedBizOpps Special Notice / Notice of Intent for Sole Source Contract
Issuing organization:
Department of Veterans Affairs, VA Ann Arbor Healthcare System, VISN 11
Contracting office:
Network Contract Activity
Contracting officer:
Thomas Auten
NAICS Code:
541990
Intended contractor:
Regents of the University of Michigan
Performance location:
University of Michigan ULAM, Ann Arbor, Michigan
Contract period:
September 1, 2012 – August 31, 2013 with four one-year options
Legal basis:
FAR 6.302-1 (Only One Responsible Source)
Response deadline:
August 31, 2012, 3:00 PM
Mailing address:
2215 Fuller Road, Ann Arbor, MI 48105, United States
Agency website:
http://vaww.ann-arbor.med.va.gov
Contact email:
[email protected]
Year:
2013
Region / City:
Ann Arbor, MI, USA
Subject:
Fire Extinguisher Inspection and Maintenance
Document Type:
Presolicitation Notice
Agency:
Department of Veterans Affairs
Contracting Office:
Network 11 Contract Office
Author / Contact:
Takya Smith, Contract Specialist
NAICS Code:
423990
Contract Type:
Firm Fixed Price Service Contract
Period of Performance:
October 1, 2013 – September 30, 2018
Response Deadline:
September 17, 2013
URL:
https://vaww.ann-arbor.med.va.gov
Funding Source:
Recovery Act Funds
Place of Performance:
VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105
Additional Information:
Solicitation package available from www.fbo.gov
Year:
2024
Region / City:
Washington, USA
Topic:
Arbor Day Reimbursement Request
Document Type:
Report and Request Form
Organization / Institution:
Washington State Department of Natural Resources
Author:
Unknown
Target Audience:
Tree City USA communities, Tree Campus USA institutions
Period of Validity:
Ongoing
Approval Date:
March 2024
Date of Changes:
March 2024
Year:
2023
Region / City:
Not specified
Topic:
Account setup
Document Type:
Email
Organization / Institution:
Arbor Academy
Author:
Not specified
Target Audience:
Parents
Action Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2015
Agency:
Department of Veterans Affairs
Office:
Ann Arbor Healthcare System, Network 11 Contracting Office
Document Type:
Justification and Approval Notice
Subject:
Endoprosthesis Stents
Award Amount:
$8,200.00
Award Date:
12-07-2015
Awardee:
W. L. Gore & Associates, Inc.
Awardee Address:
1500 N 4th St, Flagstaff, AZ 86004-2400, USA
Contracting Officer:
Kellie Konopinski
POC Email:
[email protected]
Statutory Authority:
FAR 6.302-1
Unique Features:
Proprietary stent sizes required for patient treatment and only available from W. L. Gore & Associates
Market Research:
Conducted previously by Clinical Product Review Committee; no alternative sources available
Estimated Delivery Date:
12-24-2015
Acquisition Plan Action ID:
VA251-16-AP-0843
Date:
8/21/2025
Region / city:
Arbor View
Sport:
Tennis
Document type:
Sports schedule
Author:
Arbor View
Target audience:
Students, players, and coaches
Period of validity:
Fall 2025
Date of approval:
8/21/2025
Context:
A schedule for the Arbor View High School tennis team for the fall of 2025, listing match dates, opponents, and times.
Year:
2025
Region / City:
United States, Washington State
Subject:
Arbor Day tree planting and community celebration
Document Type:
Grant report and reimbursement form
Organization:
Washington State Department of Natural Resources Urban & Community Forestry Program
Author:
Not specified
Target Audience:
Tree City USA communities and Tree Campus USA institutions
Grant Program:
USDA Forest Service Urban and Community Forestry Program
Maximum Reimbursement:
$500
Matching Requirement:
Minimum 50% of requested reimbursement
Submission Deadlines:
June 15 for January 1–May 31 events, December 31 for June 1–December 31 events
Required Attachments:
Receipts, event documentation, photos
CFDA Number:
10.664
Year:
2024
Region / City:
Ann Arbor, Michigan, United States
Event:
Michigan Energy Summit, Grand Rapids
Award:
Battle of the Buildings – “Biggest Loser” (Water Savings Category)
Organization:
Genesis of Ann Arbor
Partner Institutions:
St Clare’s Episcopal Church; Temple Beth Emeth
Announcing Organization:
United States Green Building Council (USGBC) Michigan
Author:
Murray Rosenthal
Author Role:
Chair, Genesis Green Team
Document Type:
News announcement / institutional report
Subject:
Water conservation, sustainability initiatives, and shared interfaith facility management
Water Reduction:
60.23% reduction in 2023 compared to 2022
Additional Recognition:
E2P2 Award for Waste Reduction and Recycling (Washtenaw County, October 2023)
Sustainability Measures:
Solar panel installation (160 panels), plumbing adjustments, dual-flush toilets, leak repairs, recycling and composting programs
Associated Organizations Using the Building:
Blue Ocean Faith; Ann Arbor Children’s House
Version Date:
14-MAY-2024
Year:
2017
Regulation:
EU No 536/2014
Document type:
Template
Topic:
Investigational Medicinal Products (IMP)
Regulatory reference:
Article 62(1) of Regulation (EU) No 536/2014
Manufacturer:
Not specified
Certification authority:
Qualified Person (QP)
Target audience:
Manufacturers, sponsors, regulatory bodies
Purpose:
Harmonisation of batch release certification
Approval date:
Not specified
Modification date:
Not specified
Context:
Template for certification of investigational medicinal products batch release for clinical trials, ensuring compliance with EU regulations on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Year:
2023
Region / city:
EU
Topic:
Medical Device Safety
Document Type:
Checklist
Organization:
European Commission
Author:
European Commission
Target Audience:
Medical device manufacturers
Effective Period:
Ongoing
Approval Date:
2023
Revision Date:
Not specified
Year:
2016
Region / city:
EU
Theme:
Pharmaceutical Regulation
Document Type:
Guideline
Organization:
EFPIA
Author:
Sini Eskola
Target audience:
Regulatory authorities, pharmaceutical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Year
Document type:
Accountability log
Scope:
Clinical investigation site
Subject matter:
Investigational medical devices
Regulatory framework:
EU Regulation 2017/745 on Medical Devices (MDR)
Applicable date:
26 May 2021
Version date:
18 August 2021
Responsible organization:
Kliniska Studier Sverige
Responsible network:
National network for clinical investigations with medical devices within Clinical Studies Sweden
Geographical context:
Sweden
Intended setting:
Clinical investigation site(s)
Signatory role:
Principal Investigator
Source category:
Clinical research documentation
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Year:
2023
Region / City:
Portland
Topic:
Clinical Research
Document Type:
Form
Author:
VA Portland Health Care System
Target Audience:
Researchers, Investigators, IRB Members
Period of Action:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified