№ lp_1_2_15989
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This document outlines the process for student assessment, resubmission, and the associated declarations by both students and assessors.
Note:
Year
Document Type:
Assessment Form
Institution:
Pearson
Author:
Pearson
Target Audience:
Students, Assessors
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Year:
2023
Region / city:
Australia
Topic:
Oncology, Pharmaceuticals
Document Type:
Resubmission
Institution:
Australian Government, Pharmaceutical Benefits Advisory Committee
Author:
AstraZeneca Pty Ltd.
Target Audience:
Healthcare professionals, regulatory bodies
Effective Period:
Ongoing
Approval Date:
November 2021
Date of Changes:
November 2021
Year:
2022
Country:
Australia
Therapeutic area:
Oncology
Disease:
Endometrial cancer
Biomarker status:
Mismatch repair deficient (dMMR)
Medicine name:
Dostarlimab
Brand name:
Jemperli
Dosage form:
Solution concentrate for intravenous infusion
Sponsor:
GlaxoSmithKline Australia Pty Ltd
Regulatory body:
Pharmaceutical Benefits Advisory Committee
Submission type:
Standard Re-entry submission
Requested listing:
Section 100
Comparator treatments:
Standard of care chemotherapy; pembrolizumab plus lenvatinib; pembrolizumab monotherapy
Clinical trial referenced:
GARNET
Approval status:
Provisional approval
Indication:
Recurrent or advanced endometrial cancer after platinum-containing regimen
Decision context:
PBS listing consideration
Period covered:
Up to November 2022
Drug name:
Apremilast
Brand name:
Otezla
Dosage form:
Tablet
Strength:
30 mg
Pack composition:
4 tablets of 10 mg, 4 tablets of 20 mg, 19 tablets of 30 mg
Sponsor:
Amgen Australia Pty Ltd
Regulatory status:
TGA registered
TGA registration date:
19 March 2015
Indication:
Severe plaque psoriasis
Previous indication:
Psoriatic arthritis and moderate to severe plaque psoriasis
Application type:
Minor resubmission
Requested listing:
PBS General Schedule, Authority Required (STREAMLINED)
Comparator:
Cyclosporin
Clinical population:
Patients with severe plaque psoriasis intolerant of or contraindicated to methotrexate
Primary outcome:
PASI-75 at 16 weeks
Clinical claim:
Non-inferior comparative efficacy and safety versus cyclosporin
Regulatory body:
Pharmaceutical Benefits Advisory Committee
Submission history period:
2015–2018
Geographic scope:
Australia
Source type:
Public summary document excerpt
Year:
2019–2020
Region / country:
Australia
Subject:
Chronic migraine treatment and drug listing
Document type:
Public Summary Document (PSD)
Organization / authority:
Pharmaceutical Benefits Advisory Committee (PBAC), TGA
Drug:
Galcanezumab (Emgality)
Other drugs referenced:
Fremanezumab, Erenumab, Botox
Target population:
Adults with chronic migraine unresponsive to at least three prophylactic migraine medications
Administration form:
Injection 120 mg/1 mL pre-filled pen
Prescription restrictions:
Streamlined listing, treatment by neurologist required, specific clinical criteria for migraine frequency and prior treatment response
Consumer input:
Included 186 individuals, 2 health professionals, 1 organization
Cost analysis:
Cost-minimisation analysis (CMA) versus Botox
Risk sharing arrangement:
Included, with expenditure cap adjustments
Year:
2019
Region / city:
Australia
Theme:
Oncology, Chemotherapy
Document type:
Resubmission for PBS listing
Organ / institution:
PBAC (Pharmaceutical Benefits Advisory Committee)
Author:
Bristol-Myers Squibb Australia Pty Ltd
Target audience:
Medical professionals, PBAC members
Validity period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Medicine:
Midazolam oromucosal solution in pre-filled syringe
Brand name:
Zyamis®
Sponsor:
Clinect Pty Ltd
Dosage forms:
2.5 mg/0.25 mL; 5 mg/0.5 mL; 7.5 mg/0.75 mL; 10 mg/1 mL
Indication:
Treatment of generalised convulsive status epilepticus (GCSE) in patients over 6 months of age
Regulatory authority:
Therapeutic Goods Administration (TGA)
ARTG listing date:
22 April 2022
Advisory body:
Pharmaceutical Benefits Advisory Committee (PBAC)
Submission type:
Early re-entry resubmission
Requested listing:
Section 85 Authority Required (telephone/online)
Additional request:
Prescriber Bag Schedule listing for Medical Practitioners
Comparative medicine:
Midazolam hydrochloride injection 5 mg/mL
Proposed maximum quantity:
2 pre-filled syringes per prescription
Estimated financial impact:
$20 million to < $30 million over six years
Previous consideration:
July 2022 PBAC meeting
Source:
Public Summary Document (PSD), July 2022
Year:
2021
Region / City:
Australia
Document Type:
Public Summary Document (PSD)
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Healthcare professionals, Medical Practitioners
Period of Effect:
2021-2022
Approval Date:
15 July 2021
Revision Date:
November 2021
Year:
2026
Region / city:
Colorado
Theme:
Education, Curriculum Design
Document Type:
Guidelines, Course Proposal
Institution:
Colorado State University
Author:
Curriculum & Catalog Unit
Target Audience:
Faculty, Academic Administrators, Curriculum Committees
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Topic:
Diversity, Equity, and Inclusion
Document Type:
Course Proposal
Institution:
Colorado State University
Target Audience:
CSU faculty, curriculum committees, and academic departments
Year:
2023
Region / City:
Australia
Topic:
Oncology, Haematology, Pharmaceutical Submission
Document Type:
Submission Request
Organisation:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Amgen Australian Pty Ltd
Target Audience:
Healthcare professionals, Pharmaceutical industry
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A
Year:
2021
Region / city:
South Gloucestershire, Kingswood
Topic:
Planning Application
Document Type:
Consultation Response
Organization / Institution:
The Coal Authority
Author:
James Smith
Target Audience:
Case Officer, Local Planning Authorities
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2026
Region / City:
United Kingdom
Subject:
Professional supervision and accreditation
Document type:
Guidance form
Organization / Institution:
British Association for Counselling and Psychotherapy (BACP)
Author:
BACP Accreditation Department
Target audience:
Supervisors and applicants for accreditation
Purpose:
To provide instructions for completing a supervisor statement as part of the accreditation resubmission process
Relevant legislation:
GDPR, Data Protection Act 2018
Sections included:
Applicant details, Supervisor details, Supervision contract, Comments, Signatures
Format:
Digital form for online submission
Year:
2026
Institution:
Orthopaedic outpatient clinic
Document type:
Medical case report
Authors:
Multiple, corresponding author indicated
Patient age:
40
Patient gender:
Male
Patient smoking status:
Smoker
Medical condition:
Recurrent giant-cell tumor of proximal humerus with pulmonary metastasis
Procedures:
Wide excision, hemiarthroplasty using Austin Moore prosthesis
Histopathology results:
Postoperative biopsy showed recurrent giant-cell tumor, no sign of malignancy initially; malignant GCT after shoulder disarticulation
Infection:
S. aureus, treated with specific antibiotics
Consent:
Informed consent obtained from patient
Follow-up outcome:
Patient deceased 2 years post-disarticulation due to loss of follow-up and missed chemotherapy
Imaging:
X-ray, CT scans partially performed, some unavailable
References:
Added discussion and references following JKKI style
Note:
Year
Subject:
Professional Learning
Document Type:
Guideline
Target Audience:
Teachers
Period of Validity:
One calendar year from original submission
Year:
2012/17
Region / City:
United States
Subject:
Postsecondary Education, Longitudinal Studies
Document Type:
Statistical Study
Agency / Institution:
National Center for Education Statistics, U.S. Department of Education
Author:
National Center for Education Statistics
Target Audience:
Researchers, Policymakers, Educational Institutions
Period of Action:
2017
Approval Date:
August 2016
Amendment Date:
April 2017
A document detailing the data collection procedures and methodology for the 2012/17 Beginning Postsecondary Students Longitudinal Study (BPS:
12/17) conducted by the U.S. Department of Education, including data collection instruments, testing, and confidentiality procedures.
OMB Control Number:
0704-0173
Document Type:
Supporting statement for federal information collection
Subject:
Military enlistment eligibility and processing records
Forms Covered:
DD Form 1966; USMEPCOM Form 680-3A-E
Legal Authority:
Title 10 U.S. Code §§ 504, 505, 508, 1012; Title 14 U.S. Code §§ 351, 632; Title 50 U.S. Code App. § 451; Executive Order 9397
Issuing Bodies:
Department of Defense; Military Entrance Processing Command; Armed Forces of the United States; United States Coast Guard
Purpose:
Collection and verification of applicant data for enlistment eligibility and personnel records
Population Covered:
Applicants for enlistment in the Armed Forces and Coast Guard
Information Handling:
Personally Identifiable Information maintained under DoD privacy and security regulations
Publication Dates:
Federal Register notices published June 4, 2014 and July 31, 2014
Regulatory Framework:
5 CFR 1320.5 and 5 CFR 1320.8
Year:
2015
Organization:
National Animal Health Monitoring System
Address:
2150 Centre Ave, Bldg B, Fort Collins, CO 80526
Agency:
Animal and Plant Health Inspection Service, Veterinary Services
Form Approval:
OMB Number 0579-0269
Form Expiration Date:
XX/20XX
Document Type:
Data collection instructions and record
Target Species:
Equids (horses, mules, donkeys, ponies)
Data Collection Period:
July 2014 – 2015
Year:
2023
Region / city:
Migori
Topic:
Appeal proceedings, judicial review
Document type:
Court ruling
Institution:
Environment and Land Court, Migori
Author:
Not specified
Target audience:
Legal professionals, litigants
Period of validity:
2023
Approval date:
2025
Date of amendments:
None
Note:
Contextual description