№ lp_1_25275
File format: docx Character count: 90772 File size: 312 KB
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.
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Submission of comments on Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products (Revision 2), 14 October 2016
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
FCC Votes to Enable Better, Faster Wi-Fi and Next-Gen ConnectivityExpands Unlicensed Operations in the 6 GHz Band to Empower Innovative GVP Devices
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
Topics: Product- EMA6530362019 GVP