№ lp_1_2_53259
File format: docx
Character count: 3637
File size: 93 KB
A document that outlines a Six Sigma project charter example with information on project scope, resources, deliverables, risks, costs, and benefits for a procurement improvement initiative.
Note:
Year
Price: 8 / 10 USD
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Year:
2020
Region / city:
Australia
Topic:
Biosimilar medicine submission
Document type:
Pharmaceutical submission
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Maxx Pharma Pty Ltd
Target audience:
Healthcare professionals, regulatory bodies
Period of validity:
Ongoing
Approval date:
November 2022
Modification date:
November 2022
Year:
2025
Region / City:
Australia
Topic:
Oncology, Medical Treatment
Document Type:
Submission
Organization / Institution:
Taiho Pharma Oceania Pty Ltd
Author:
Taiho Pharma Oceania Pty Ltd
Target Audience:
Medical practitioners, healthcare professionals, regulatory bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Region / city:
Australia
Subject:
Urothelial cancer treatment
Document type:
Submission
Organization / institution:
TGA, PBAC
Author:
Not specified
Target audience:
Medical professionals
Period of validity:
2024–2026
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / city:
Australia
Subject:
Medical treatment
Document Type:
Submission for drug listing approval
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
VIFOR PHARMA PTY LIMITED
Target audience:
Healthcare professionals, regulatory bodies
Period of validity:
N/A
Approval date:
17 January 2023
Date of changes:
N/A
Context:
The document is a pharmaceutical submission for the inclusion of avacopan on the Pharmaceutical Benefits Scheme (PBS) for the treatment of severe active granulomatosis with polyangiitis and severe active microscopic polyangiitis in combination with other medications.
Year:
2020
Region / City:
Goodland, KS
Field:
Medicine, Law
Document Type:
Resume/Curriculum Vitae
Organization / Institution:
Mitchell Hamline School of Law, Indiana University School of Medicine, University of Chicago
Author:
Norman D. Means, MD
Target Audience:
Potential employers in medical-legal fields, law and healthcare professionals
Period of Action:
2020-2025
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2020
Region / city:
Australia
Theme:
Medical treatment
Document type:
Regulatory submission
Organization / institution:
Dr Falk Pharma Australia
Author:
Dr Falk Pharma Australia
Target audience:
Medical professionals, regulatory bodies
Treatment phase:
Induction of remission
Date of approval:
15 September 2020
Date of amendments:
N/A
Registration status:
TGA registered
Regulatory agencies involved:
TGA, EMA, Switzerland, Canada, Israel
Requested listing:
PBS listing
Indication:
Eosinophilic oesophagitis
Dosage:
1 mg orally disintegrating tablet, BID
Safety:
Inferior compared to placebo
Efficacy:
Superior compared to placebo
Comparator:
Placebo
Clinical claim:
Efficacy superiority, safety inferiority
Date of evaluation phase completion:
31 August 2021
End of evaluation period:
14 January 2022
Type of product:
Orally disintegrating tablet (BOT)
Purpose:
Treatment of eosinophilic oesophagitis
Medical criteria:
Eosinophilic infiltration of the oesophagus confirmed by biopsy
Treatment criteria:
Must be treated by a gastroenterologist
Administrative requirements:
Applications within XX weeks of biopsy
Year:
2021
Region / City:
Australia
Subject:
Pharmaceutical submission
Document Type:
Submission for listing
Organization / Institution:
Astellas Pharma Australia Pty Ltd
Author:
Astellas Pharma Australia Pty Ltd
Target Audience:
Medical practitioners, regulatory bodies
Effective Period:
Since April 2021
Approval Date:
Not specified
Amendment Date:
Not specified
TRABECTEDIN, Powder for I.V. infusion 0.25mg, 1mg Yondelis®, Specialised Therapeutics Pharma Pty Ltd
Year:
2021
Region / City:
Australia
Topic:
Medical treatment, Oncology
Document type:
Submission
Organization / Institution:
Specialised Therapeutics Pharma Pty Ltd
Author:
Specialised Therapeutics Pharma Pty Ltd
Target audience:
Healthcare professionals, medical practitioners
Period of validity:
2021–present
Approval date:
21 April 2021
Modification date:
None
Registration status:
TGA approved
Condition:
Leiomyosarcoma (LMS)
Indication:
Advanced (unresectable and/or metastatic) leiomyosarcoma
Treatment phase:
Initial treatment, continuing treatment, and grandfather treatment
Price:
Public hospital: $8,962.05; Private hospital: $9,126.95
Prescriber type:
Medical practitioners, nurse practitioners
Restriction type:
Authority Required – Streamlined
Special pricing arrangements:
Yes
Administrative advice:
Not PBS-subsidised for inpatient use in public hospitals
Clinical criteria:
Must have received prior chemotherapy treatment including anthracycline
Population criteria:
Patients aged 18 years or older
Epidemiology:
Advanced soft tissue sarcoma
Methodology:
Cost-minimisation analysis compared to pazopanib
HRQoL:
Health-related quality of life assessed via MD Anderson Symptom Index
Outcome measures:
Progression-free survival, overall response rate, overall survival, time to progression
Comparator:
Pazopanib
Clinical claim:
Trabectedin is non-inferior in terms of safety compared to pazopanib for LMS treatment
Year:
2026
Region / City:
Australia
Topic:
Pharmaceutical Application
Document Type:
Authority Submission
Organization / Institution:
TEVA Pharma Australia Pty Ltd
Author:
Not specified
Target Audience:
Health care professionals, including dental medical practitioners, nurse practitioners, optometrists, midwives
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2026
Region / City:
Waltloo, Region 6, South Africa
Subject:
Telecommunication Infrastructure Construction
Document Type:
Practical Completion Certificate
Organization:
Roads and Transport, Infrastructure Provision (IP)
Consultant:
Ceenex (PTY) LTD
Contractor:
Frogfoot Networks
Professional Engineer:
Mr Sarel Holtzhausen, ECSA registration No: 20070012
Inspector:
Kholofelo P. Aphane
Address:
Battery Road, Waltloo
Certificate Date:
2026-03-03
Contract Reference:
WL2425-0806 FRG8316608-JHB-B1
Scope of Work:
Trenching, backfilling, duct installation, manhole construction, fiber installation and jointing
Year:
2023
Region / City:
Victoria, Australia
Topic:
Class Action Lawsuit
Document Type:
Legal Notice
Organization / Institution:
Supreme Court of Victoria
Author:
Benjumin Hillman (plaintiff), Phi Finney McDonald (lawyers)
Target Audience:
Shareholders of Mayne Pharma Group Ltd who acquired shares between 24 November 2014 and 15 December 2016
Period of Validity:
24 November 2014 to 15 December 2016
Approval Date:
28 June 2023
Amendment Date:
N/A
Context:
Legal notice informing potential class action members about their rights in the Mayne Pharma Group Ltd shareholder class action, detailing the opt-out process and settlement opportunities.
Year:
2023
Region / City:
Australia
Topic:
Pharmaceutical Product Submission
Document Type:
Submission to PBS
Organization / Institution:
Australian Government Department of Health
Author:
Aspen Pharma Pty Ltd
Target Audience:
Healthcare Professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Organization:
Sigma Gamma Rho Sorority, Incorporated
Chapter:
Xi Beta Chapter, University of Toledo
Document Type:
Bylaws guide
Audience:
Chapter officers and members
Reference:
Robert’s Rules of Order Newly Revised (RONR)
Content Focus:
Governance structure, membership, officer duties, meetings, committees, parliamentary authority, amendments
Year:
2026
Region / City:
Global
Topic:
Industrial equipment, Compressed air supply
Document type:
Product information / Contracting model description
Organization:
Kaeser Kompressoren
Target audience:
Industrial clients, manufacturing companies
Key features:
Cost-effective compressed air supply, energy efficiency, maintenance and monitoring included, fixed-price contract per cubic metre of air
File:
l-contracting-en3.478
Year:
Not specified
Region / City:
Appalachian State University
Theme:
Fraternity membership and governance
Document Type:
By-Laws
Organization / Institution:
Sigma Nu Fraternity
Author:
Not specified
Target Audience:
Members of Sigma Nu Fraternity, potential candidates for membership
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2010
Region / city:
Michigan, Mt. Pleasant
Subject:
Organizational Policies and Procedures
Document Type:
Sorority Policy
Organization:
Delta Sigma Theta Sorority, Inc.
Author:
Not specified
Target Audience:
Sorority members
Period of validity:
Not specified
Approval Date:
Not specified
Date of amendments:
Not specified
Note:
Year
Region / City:
California State Polytechnic University, Pomona
Subject:
Sorority Membership, Organizational Rules
Document Type:
Bylaws/Constitution
Organization:
Sigma Gamma Rho Sorority, Inc.
Target Audience:
Students of California State Polytechnic University, Pomona, members of Sigma Gamma Rho Sorority
Year:
N/A
Region / City:
Appalachian State University
Topic:
Fraternity Membership and Organization
Document Type:
By-Laws
Organization / Institution:
Sigma Nu Fraternity
Author:
N/A
Target Audience:
Members of the Kappa Epsilon Chapter of Sigma Nu Fraternity
Period of Validity:
N/A
Approval Date:
N/A
Date of Amendments:
N/A