№ files_lp_4_process_3_121951
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Year: 2023
Region / city: Not specified
Topic: Psychiatry / Case Presentation
Document Type: Assignment Instructions
Author: Not specified
Target audience: Medical/Clinical students
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Context description: Assignment instructions for creating a focused SOAP note and developing a patient case presentation, with an emphasis on psychiatric assessment and treatment planning.
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Rental Assistance Demonstration for PRAC: Closing Overview & Checklist: Project Based Voucher (PBV) Conversions
Note: Year
CHMP and PRAC Joint Assessment Report on Generic/Hybrid Medicinal Product Procedure EMEA/H/C/
Note: Year
Region / city: Amsterdam
Type of document: Assessment report
Committee / organization: Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC)
Procedure number: EMEA/H/C/
Rapporteurs: CHMP Rapporteur, PRAC Rapporteur
Product type: Generic/hybrid medicinal product
Confidential information included: Yes / No
Pharmacovigilance Risk Assessment Committee (PRAC) PSUR assessment report template and guidance for nationally authorised medicinal products
Year: 2015
Type of document: Assessment report template
Subject: Pharmacovigilance, Periodic Safety Update Reports (PSUR)
Organization: European Medicines Agency (EMA)
Target audience: Lead Member States, MAHs, PRAC members
Procedure number: Not specified
Data lock point: Not specified
Status: Guidance and procedural template
References: GVP Module V, VII, VIII; Variations Classification guideline Commission Regulation 1234/2008; HMA/EMEA recommendations EMEA/743133/2009
Pharmacovigilance Risk Assessment Committee (PRAC) Signal assessment report
Year: 2022
Region / city: EU
Theme: Pharmacovigilance
Document type: Report
Organization: European Medicines Agency (EMA)
Author: PRAC
Target audience: Healthcare professionals, regulatory authorities
Period of validity: N/A
Date of approval: DD Month YYYY
Date of modifications: N/A
Contextual description: Report providing detailed information on signal assessment and recommendations related to pharmacovigilance procedures for a specific safety signal in the EU.
Pharmacovigilance Risk Assessment Committee (PRAC) non-interventional imposed PASS final study report assessment report
Year: 2026
Region / city: European Union
Subject: Pharmacovigilance
Document Type: Final Study Report
Organization / Institution: European Medicines Agency (EMA)
Author: PRAC Rapporteur
Target Audience: EMA committee members, Marketing Authorisation Holders (MAH)
Period of Validity: Until completion of procedure
Date of Approval: 2026-02-24
Date of Changes: None
PNM PRAC August 2025 Meeting
Year: 2025
Region / City: New Mexico
Topic: Energy Rate Design
Document Type: Meeting Notes
Organization / Institution: PNM
Author: Not specified
Target Audience: PNM staff, stakeholders, and energy industry professionals
Effective Date: August 2025
Date of Approval: Not specified
Date of Changes: Not specified
Regional Planning Review and Adjustment Committee (PRAC) Meeting Agenda 2025-1 — April 22, 2025
Year: 2025
Date of meeting: April 22, 2025
Time: 2:00 p.m.
Location: GMSC Boardroom, 1773 Water Street (lower level, accessible from Loggie Drive), Miramichi
Region / City: Miramichi, New Brunswick, Canada
Organization: Greater Miramichi Service Commission
Committee: Planning Review and Adjustment Committee (PRAC)
Document type: Meeting agenda
Meeting number: 2025-1
Agenda items: Approval of agenda; Approval of minutes (Meetings 2024-9 and 2024-10); Selection of Chairperson and Vice-Chairperson; Declaration of conflict of interest; Review of tentative subdivision plan
Applicant: Randy Waye, T.G. Williston Surveys Ltd.
Staff presenter: Julien Robichaud, Development Officer
Project: RAS CAN–IND Ltd. Subdivision — Plan 2025-1
Area concerned: St. Margarets, Parish of Glenelg
Legal reference: New Brunswick Regulation 80-159 under the Community Planning Act (c.19)
Purpose: Committee review and advice regarding proposed future access related to a subdivision plan
Remote access: MS Teams meeting link with Meeting ID and passcode
Submission of comments on Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC), 15 October 2014
Year: 2014
Organization: EFPIA
Author: Sini Eskola
Recipient: European Medicines Agency (EMA)
Document type: Comment submission
Subject: Public hearings procedures at PRAC
Regulation reference: Regulation 726/2004, Directive 2001/83/EC
Intended audience: EMA, stakeholders in pharmacovigilance
Date submitted: 15 October 2014
Format: Word document
Mode of submission: Electronic
Stakeholder number: Not assigned
Meeting Minutes Surface Transportation Board Passenger Rail Advisory Committee (PRAC) Meeting No. 4
Date: Thursday, September 18, 2025
Year: 2025
Region / City: United States
Topic: Passenger Rail, Liability, Insurance
Document Type: Meeting Minutes
Organization: Surface Transportation Board (STB)
Authors: Brian O’Boyle, Henry Posner, Jim Derwinski, Lori Winfree, etc.
Target Audience: PRAC members, STB staff, industry stakeholders
Period of Action: September 18, 2025
Date of Approval: N/A
Date of Amendments: N/A
Topics: 6665-WEEK ASSIGNMENTFOCUSED PRAC