№ lp_1_2_47693
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Stakeholder commentary submitted to a European regulatory consultation outlining industry positions and concerns regarding proposed revisions to a pharmacovigilance guideline governing the management and submission of adverse reaction reports.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2020
Region / city:
Europe
Topic:
Pharmacovigilance, Pregnant and breastfeeding women
Document type:
Consultation comments
Organization:
EFPIA
Target audience:
Healthcare professionals, Regulatory authorities
Period of validity:
Ongoing
Approval date:
28th February 2020
Date of changes:
N/A
Context:
Comments on the European Medicines Agency (EMA) guidelines for pharmacovigilance regarding pregnant and breastfeeding women, focusing on clarifications and additional guidance in the document.
Year:
2026
Region / city:
Washington
Topic:
Wireless Communication, IoT, AR/VR
Document Type:
Order
Organization / Institution:
Federal Communications Commission
Author:
Federal Communications Commission
Target Audience:
Industry professionals, consumers, wireless and IoT technology developers
Period of Action:
January 29, 2026
Approval Date:
January 29, 2026
Amendment Date:
N/A
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:
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
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
Year:
2018-2019
Region / City:
New South Wales, Australia
Topic:
Chemistry
Document Type:
Educational Guide
Organization / Institution:
NSW Department of Education
Author:
NSW Department of Education
Target Audience:
Teachers of Year 12 Chemistry
Effective Period:
2018-2019
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Not specified
Subject:
Chemistry
Document Type:
Educational Resource
Institution:
CCEA
Author:
Not specified
Target Audience:
Students, Teachers
Period of Validity:
Not specified
Approval Date:
Not specified
Revision Date:
Not specified
Document type:
Classroom worksheet
Subject area:
Chemistry
Topic:
Chemical equilibrium and reversible reactions
Educational level:
Secondary education
Simulation platform:
PhET Interactive Simulations
Institution:
University of Colorado Boulder
Activities included:
Guided exploration, experiments, data collection, graphing, investigation
Key variables:
Time, temperature, concentration, activation energy, molecule ratio
Molecule types:
Green (A), Red (B)
Assessment components:
Data tables, graphs, written responses, presentation
Source type:
Educational activity handout
Year:
2014
Region / city:
Bethesda, MD
Topic:
Blood transfusion, platelet washing
Document type:
Procedure manual
Organization / institution:
AABB
Author:
MK Fung
Target audience:
Healthcare professionals in transfusion services
Period of validity:
Not specified
Approval date:
September 1, 2014
Date of revisions:
September 1, 2014
Revision history:
Revised name of manual, revised principle, updated references
Context:
This document outlines the procedure for washing platelets in order to minimize the risk of allergic reactions in recipients.
Note:
Year
Subject:
Biology
Document Type:
Practical Activity
Organization / Institution:
OCR
Target Audience:
Teachers and Technicians
Year:
2026
Region / city:
Not specified
Subject:
Chemistry
Document type:
Educational curriculum
Author:
Not specified
Target audience:
Students
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2026
Region / city:
Bristol, Mumbai, Belo Horizonte, Campo Grande, Rio de Janeiro
Subject:
Trypanocidal drugs, Chagas disease, Quinones, Chemistry
Document type:
Research article
Institution:
University of Bristol, Indian Institute of Technology Bombay, Federal University of Minas Gerais, Federal University of Mato Grosso do Sul, FIOCRUZ
Author:
James M. Wood, Nishikant S. Satam, Renata G. Almeida, Vinicius S. Cristani, Dênis P. Lima, Luiza D. Pereira, Kelly Salomão, Rubem F. S. Menna-Barreto, Irishi N. N. Namboothiri, John F. Bower, Eufrânio N. da Silva Júnior
Target audience:
Researchers, chemists, biochemists, pharmaceutical scientists
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Subject:
Chemistry
Topic:
Activity (Reactivity) Series
Document Type:
Educational explanatory text
Key Concepts:
Reactivity series, displacement reaction, reducing agents, metal-water reactions
Chemical Elements Mentioned:
Zinc, Copper, Magnesium, Potassium, Iron, Silver, Mercury, Gold, Hydrogen, Fluorine, Chlorine, Oxygen, Bromine, Iodine, Sulphur, Phosphorus
Compounds Mentioned:
Copper(II) tetraoxosulphate (VI), Zinc tetraoxosulphate (VI), Hydrochloric acid, Tetraoxosulphate (VI) acid, Potassium iodide, Potassium chloride, Potassium hydroxide
Reactions Included:
Metal displacement reactions, Metal-acid reactions, Metal-water reactions, Non-metal displacement reactions
Equations Provided:
Zn + CuSO4 → ZnSO4 + Cu; Mg + H2SO4 → MgSO4 + H2; 2KI + Cl2 → 2KCl + I2; 2K + 2H2O → 2KOH + H2; 3Fe + 4H2O → Fe3O4 + 4H2
Educational Level:
Secondary school chemistry
Year:
Not specified
Region / City:
Not specified
Theme:
Chemical equilibria, chemical reactions
Document type:
Educational textbook section
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Students of chemistry
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Description:
Section from a chemistry textbook explaining the concept of chemical equilibrium, reaction quotients, and equilibrium constants for both homogeneous and heterogeneous reactions.
Year:
2026
Region / city:
-
Theme:
Organic Chemistry, Carbonyl Compounds, Esters
Document Type:
Educational Material
Organization / institution:
-
Author:
-
Target audience:
Students studying organic chemistry, A-levels
Period of validity:
-
Approval Date:
-
Date of modifications:
-
Note:
Contextual description
Standard:
ChemBio 1.2
Subject Area:
Chemistry and Biology
Level:
Secondary Education
Document Type:
Teacher Guidance for Assessment Activity
Focus:
Chemical reactions in te ao Māori contexts
Key Concepts:
Reaction types; reactants and products; diagnostic tests; conservation of mass; balanced chemical equations
Assessment Component:
Portfolio of laboratory practical investigations
Referenced Note:
Explanatory Note 2
Intended Audience:
Kaiako and ākonga
Educational Context:
Laboratory modelling of five specified reaction types
Learning Outcomes:
Identification and categorisation of reaction types; selection of generic and chemical terms; application of balanced equations; explanation of conservation of mass
Year:
2024
Region / city:
India
Topic:
Immunology, Biotechnology
Document type:
Book Chapter
Institution:
Tomo Riba Institute of Health & Medical Sciences (TRIHMS)
Author:
Ashmita Banik
Target audience:
Scientific community, Researchers in Biotechnology and Immunology
Period of validity:
N/A
Approval date:
N/A
Date of changes:
N/A
Year:
2014
Region / City:
Colorado
Subject:
Science
Document Type:
Educational Resource
Author:
Diann Mazingo, Mark Paricio, Brian Duchemin, Claudia Wallace, Kara Butterworth, Meadow Reynolds
Target Audience:
Teachers, Educators, School Districts
Period of Use:
Ongoing
Approval Date:
March 31, 2014
Modification Date:
N/A