№ files_lp_4_process_2_62794
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A regulatory comment submission addressing the draft procedures for organizing public hearings at the PRAC, including recommendations on criteria, communication, stakeholder involvement, and assessment of safety in context of medicinal product benefits.
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
Price: 8 / 10 USD
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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
Date:
14 October 2016
Document type:
Stakeholder comments
Subject:
Good pharmacovigilance practices
Guideline reference:
GVP Module VI (Rev 2)
Regulatory framework:
European Union pharmacovigilance legislation
Organisation:
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Author:
Sini Eskola
Recipient institution:
European Medicines Agency
Related standards:
ICH E2B (R2), ICH E2B (R3)
Key topics:
Individual Case Safety Reports, adverse reaction reporting, EudraVigilance, validation rules, terminology consistency
Position of author:
Industry stakeholder
Public disclosure status:
Intended for publication by the Agency
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.
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
Year:
2011
Region / City:
Madagascar
Topic:
Health, Pharmacovigilance
Document Type:
Policy
Organization:
Ministry of Public Health, Madagascar
Author:
Ministry of Public Health
Target Audience:
Health professionals, stakeholders in health development
Effective Period:
Not specified
Approval Date:
October 2011
Amendment Date:
Not specified
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
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
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.
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
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
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
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
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.
Year:
2000
Region / City:
South Carolina
Topic:
Fair hearings, legal procedures
Document Type:
Regulations
Agency:
South Carolina Department of Social Services
Author:
South Carolina Department of Social Services
Target Audience:
Individuals involved in child care, adoption, social services
Period of validity:
Ongoing
Approval Date:
July 28, 2000
Date of Changes:
July 28, 2000
Year:
N/A
Region / City:
Sacramento, CA
Subject:
Self-Determination, Fair Hearing Process
Document Type:
Guide
Author:
Katie Hornberger
Target Audience:
Regional Center consumers, participants of Self-Determination Program
Effective Period:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Year:
2022
Region / City:
Oak Island, North Carolina
Topic:
Local government, zoning ordinances, public hearing
Document Type:
Meeting minutes
Organization:
Oak Island Town Council
Author:
Oak Island Town Council
Target Audience:
Local residents, town officials, stakeholders in zoning matters
Period of Validity:
N/A
Approval Date:
March 8, 2022
Date of Changes:
N/A
Year:
2022
Region / city:
Great Britain
Topic:
Remote hearings, Pharmacy, Patient safety
Document type:
Response to consultation
Organization:
Royal Pharmaceutical Society
Author:
Jonathan Lloyd Jones
Target audience:
General Pharmaceutical Council, Pharmacy professionals, Stakeholders
Validity period:
N/A
Approval date:
February 7, 2022
Amendment date:
N/A
Case No:
[…]
Year:
2020
Region / City:
England and Wales
Subject:
Remote hearings in court proceedings
Document type:
Legal order
Author:
[Court]
Target audience:
Legal professionals, court participants
Period of validity:
Until further notice
Date of approval:
[date of order]
Date of amendments:
[if applicable]
Year:
2020
Region / City:
Bar Harbor
Topic:
Employee Housing
Document Type:
Report
Organization / Institution:
Town of Bar Harbor
Author:
Planning and Code Department
Target Audience:
Town Council, Planning Board, residents of Bar Harbor, business owners
Period of Validity:
Ongoing
Approval Date:
January 9, 2020
Date of Amendments:
January 8, 2020 (Public Hearings)