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Global Pharmacovigilance Requirements (Medicines and Vaccines)Last post
Pharmacovigilance Requirements in United States and Canada7 Topics · 12 PostsLast post: FDA VAERS - Vaccine Adverse Event … · 3 weeks ago · VigiServe AdminSubforums: United States · Canada
Pharmacovigilance Requirements in India3 Topics · 7 PostsLast post: Serious Adverse Events (SAE) and C … · 1 month ago · VigiServe Admin
Pharmacovigilance Requirements in Asia (except India)Pharmacovigilance Requirements in various countries in Asia22 Topics · 26 PostsLast post: Pharmacovigilance Requirements in … · 2 months ago · VigiServe AdminSubforums: Pakistan · Hong Kong · Japan · China · Nepal · Bhutan · Malaysia · Thailand · Philippines · Cambodia · Brunei · Srilanka · Taiwan · South Korea · Vietnam · Singapore · Bangladesh · Indonesia · Afghanistan
Pharmacovigilance Requirements in Middle East and AfricaPharmacovigilance Requirements in the various countries of Middle East and Africa32 Topics · 36 PostsLast post: Pharmacovigilance requirements in … · 2 months ago · VigiServe AdminSubforums: Ghana · Oman · Saudi Arabia · Zambia · South Africa · Zimbabwe · Tanzania · Ethiopia · Iran · Bahrain · Mauritius · Egypt · Senegal · Uganda · Morocco · Madagascar · Rwanda · Sudan · Malawi · Tunisia · UAE · Namibia · Botswana · Kuwait · Qatar · Algeria · Nigeria · Kenya · Cameroon · Lebanon · Palestine
Pharmacovigilance Requirements in LATAM and South AmericaPharmacovigilance in LATAM, South America, and other neighboring Countries (excluding US/Canada)16 Topics · 18 PostsLast post: Pharmacovigilance Requirements in … · 4 weeks ago · VigiServe AdminSubforums: Peru · Brazil · Mexico · Cuba · Ecuador · Costa Rica · Paraguay · Uruguay · Venezuela · Jamaica · Guatemala · Argentina · Bolivia · Chile · Barbados · Dominican Republic
Pharmacovigilance requirements in CIS and EuroasiaPharmacovigilance requirements in CIS and Euroasian Countries8 Topics · 9 PostsLast post: Pharmacovigilance Requirements in … · 3 months ago · VigiServe AdminSubforums: Russia · Ukraine · Kosovo · Azerbaijan · Kazakhstan · Armenia · Belarus · Kyrgyzstan
Pharmacovigilance Requirements in OceaniaPharmacovigilance Requirements in the countries of the Australian Continent (Oceania)5 Topics · 6 PostsLast post: How does MedSafe monitor vaccine s … · 3 months ago · VigiServe AdminSubforums: Australia · New Zealand
Pharmacovigilance Requirements in EuropePharmacovigilance Requirements in the countries of the European Union and neighboring Countries23 Topics · 38 PostsLast post: Freedom of Information (FOI) Relea … · 3 weeks ago · VigiServe AdminSubforums: Israel · Turkey · Switzerland · Macedonia · Serbia · Bosnia & Herzegovina · EU/EEA · United Kingdom
CosmetoVigilanceLast post
United States - CosmetoVigilanceUnited States - FDA requirements for reporting Cosmetic-Related Problem(s)1 Topic · 1 PostLast post: FDA requirements for reporting adv … · 5 months ago · VigiServe Admin
Brunei - CosmetoVigilance Requirements1 Topic · 1 PostLast post: Cosmetovigilance - Brunei · 5 months ago · VigiServe Admin
Cosmetovigilance in the ASEAN1 Topic · 1 PostLast post: ASEAN GUIDELINES - Cosmetics · 5 months ago · VigiServe Admin
EU/EEA - CosmetoVigilanceCosmetics' Safety in the European Union1 Topic · 1 PostLast post: CosmetoVigilance requirements in t … · 5 months ago · VigiServe Admin
Singapore - CosmetoVigilance RequirementsCosmetics' Safety in Singapore1 Topic · 1 PostLast post: Singapore - CosmetoVigilance Requi … · 5 months ago · VigiServe Admin
China CosmetovigilanceCosmetics' Safety in China1 Topic · 1 PostLast post: Cosmetovigilance requirements in C … · 3 months ago · VigiServe Admin
Haemovigilance or Blood VigilanceLast post
Global Hemovigilance RequirementsHemovigilance Requirements in various countries/ regions3 Topics · 3 PostsLast post: USFDA - Notification Process for T … · 5 months ago · VigiServe Admin
Medical Device Vigilance (Materiovigilance)Last post
Global Device Vigilance RequirementsDevice Vigilance Requirements in Countries/ Regions14 Topics · 17 PostsLast post: Device Vigilance Requirements in A … · 2 weeks ago · VigiServe AdminSubforums: New Zealand · Bahrain · Australia · United States · Canada · Bosnia-Herzegovina · Turkey · ASEAN · Myanmar · China · United Kingdom · EU/EEA
IMDRFIMDRF and GHTF1 Topic · 2 PostsLast post: IMDRF - International Medical Devi … · 5 months ago · VigiServe Admin
Learning Device VigilanceConcepts in Device Vigilance2 Topics · 2 PostsLast post: Distinguishing Medical Devices · 4 months ago · VigiServe Admin
Veterinary PharmacovigilanceLast post
Global Pharmacovigilance Requirements (Vet)Veterinary Pharmacovigilance Requirements in Various Countries / Regions11 Topics · 12 PostsLast post: VMD Pharmacovigilance Requirements · 2 months ago · VigiServe AdminSubforums: United States · United Kingdom · Saudi Arabia · EU/EEA · Australia · Kosovo
Coding Veterinary Adverse EventsCoding for Veterinary Pharmacovigilance3 Topics · 5 PostsLast post: Lack of efficacy - Veterinary · 3 months ago · VigiServe Admin
Causality AssessmentCausality Assessment - Veterinary Medicinal Products1 Topic · 2 PostsLast post: Causality for Veterinary Medicinal … · 2 months ago · VigiServe Admin
Events and ResourcesLast post
WHO - ResourcesPharmacovigilance resources from the WHO1 Topic · 1 PostLast post: Useful Links · 5 months ago · VigiServe Admin
Dedicated Pharmacovigilance BlogsList of all Pharmacovigilance and Drug Safety Blogs1 Topic · 1 PostLast post: Links to all blogs · 5 months ago · VigiServe Admin
Worldwide Event CalendarList of all Pharmacovigilance events around the world1 Topic · 1 PostLast post: Links · 5 months ago · VigiServe Admin
Free Pharmacovigilance CoursesFree Pharmacovigilance Courses from around the world2 Topics · 3 PostsLast post: Free Courses on Clinical Trials In … · 1 month ago · VigiServe Admin
Paid Pharmacovigilance CoursesList of Paid Pharmacovigilance Courses Globally3 Topics · 3 PostsLast post: List of Paid Pharmacovigilance Cou … · 1 month ago · VigiServe Admin
Country Specific Product LabelsGetting Access to Country Specific Labels4 Topics · 5 PostsLast post: SmPC/PIL in Europe · 4 weeks ago · VigiServe Admin
Resources for Local Literature MonitoringLocal Literature Monitoring - Global97 Topics · 97 PostsLast post: Local Journals from the United Kin … · 2 hours ago · VigiServe Admin
Pharmacovigilance Quality AssuranceLast post
Remote pharmacovigilance Inspections and Audits3 Topics · 3 PostsLast post: EMA - Remote pharmacovigilance ins … · 5 months ago · VigiServe Admin
Global Pharmacovigilance InspectionsPharmacovigilance Inspections by Regulatory Agencies Globally21 Topics · 21 PostsLast post: The risk-based approach to pharmac … · 2 months ago · VigiServe AdminSubforums: United States · Canada · Turkey · Australia · United Kingdom · Ghana · EU/EEA · Switzerland · Sierra Leone
Handling Pharmacovigilance InspectionsPreparation and management of Pharmacovigilance Inspections0 Topics · 0 PostsNo topics yet!
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Pharmacovigilance Regulatory Affairs InterfaceLast post
Urgent Safety RestrictionsLearning about the urgent safety restrictions1 Topic · 2 PostsLast post: What are Urgent Safety Restriction … · 2 months ago · VigiServe Admin
Safety VariationsLearning about the Safety Variations3 Topics · 5 PostsLast post: Type 1B variations in the European … · 2 months ago · VigiServe Admin
Safety LabelingLearning about the various aspects of Safety Labelling1 Topic · 1 PostLast post: Implementation of Safety Changes i … · 2 months ago · VigiServe Admin
Learning Drug SafetyLast post
CCDS and CCSICompany Core Data Sheet / Company Core Safety Information1 Topic · 1 PostLast post: CCDS and CCSI · 4 months ago · Manoj Swaminathan
Dear Healthcare Professional CommunicationDHCP or DHPC1 Topic · 3 PostsLast post: DHCP/DHPC · 2 months ago · VigiServe Admin
Risk ManagementRisk Management Documents - RMP and REMS7 Topics · 9 PostsLast post: Additional Risk Minimisation Measu … · 3 months ago · VigiServe Admin
MedDRAMedical Dictionary for Regulatory Activities1 Topic · 3 PostsLast post: All about MedDRA · 2 months ago · VigiServe Admin
Decoding Safety Data Exchange AgreementsSafety Data Exchange Agreements - SDEA or PVA or PDEA2 Topics · 2 PostsLast post: Does MAH need to execute Safety Ag … · 4 months ago · VigiServe Admin
AddictoVigilanceLearning AddictoVigilance1 Topic · 2 PostsLast post: Learning AddictoVigilance · 2 months ago · VigiServe Admin
DiLi - Drug Induced Liver InjuryLearning about Drug Induced Liver Injury1 Topic · 5 PostsLast post: DiLi - Drug Induced Liver Injury · 3 months ago · VigiServe Admin
DSUR, IND Annual Report and ASRDifference between DSUR, IND Annual Report, and ASR1 Topic · 1 PostLast post: Difference between DSUR, IND Annua … · 4 months ago · VigiServe Admin
Special SuppliesCompassionate Use, Emergency Use, Expanded Access and Named Patient Use1 Topic · 1 PostLast post: Special Supplies · 4 months ago · VigiServe Admin
Coding Specific ScenariosCoding Specific Scenarios using MedDRA2 Topics · 2 PostsLast post: Veterinary Pharmacovigilance - Spe … · 4 months ago · VigiServe Admin
IDMP - Identification of Medicinal ProductsIdentification of Medicinal Products (IDMP)1 Topic · 2 PostsLast post: All about IDMP - Identification of … · 2 months ago · VigiServe Admin
EcoPharmacovigilanceWhat is EcoPharmacovigilance or Environmental Pharmacovigilance or Pharmacoenvironmentology?1 Topic · 2 PostsLast post: What is Ecopharmacovigilance? · 4 months ago · VigiServe Admin
Post Authorization Safety Studies (PASS)PASS Studies1 Topic · 1 PostLast post: What are PASS Studies? · 3 months ago · VigiServe Admin
Paediatric investigation plansLearning Paediatric investigation plans (PIP)1 Topic · 3 PostsLast post: Paediatric investigation plans · 3 months ago · VigiServe Admin
Defining a New IndicationHow do you define a new indication?1 Topic · 1 PostLast post: Defining a New Indication · 3 months ago · VigiServe Admin
Patient RegistriesRegistry-based Studies3 Topics · 3 PostsLast post: Population Registries · 3 months ago · VigiServe Admin
Signal ManagementLearning about Signal Management2 Topics · 6 PostsLast post: Signal Management in the European … · 2 months ago · VigiServe Admin
Literature ManagementLiterature Search and Management3 Topics · 10 PostsLast post: Local Literature Monitoring · 2 months ago · Manoj Swaminathan
Eudravigilance L2A and L2B Case ReportsL2A and L2B Case Reports in Eudravigilance1 Topic · 2 PostsLast post: L2A, L2B and MLM - export Function · 2 months ago · VigiServe Admin
Post Authorization Efficacy Studies (PAES)Learn about Post-authorisation efficacy studies1 Topic · 2 PostsLast post: Definition and the need for PAES · 2 months ago · VigiServe Admin
Reference Safety InformationLearn about Reference Safety Information (RSI)2 Topics · 3 PostsLast post: RSI for Clinical Trials · 2 months ago · VigiServe Admin
Patient support programmeLearning about Patient support program2 Topics · 4 PostsLast post: What is a Market Research Programm … · 2 months ago · VigiServe Admin
Boxed Warnings - United StatesFDA Boxed Warnings1 Topic · 3 PostsLast post: What are Boxed Warnings? · 1 month ago · VigiServe Admin
Product RecallsProduct Recalls and the Safety Aspects2 Topics · 3 PostsLast post: Product Recalls · 1 month ago · VigiServe Admin
Public assessment reports (PAR)Learning about PARs2 Topics · 2 PostsLast post: Australian Public Assessment Repor … · 3 weeks ago · VigiServe Admin
Safety AutomationLast post
Basic ConceptsAutomation, Artificial Intelligence, and beyond!2 Topics · 2 PostsLast post: Examples - Automation in Pharmacov … · 3 months ago · VigiServe Admin
Jobs and OpportunitiesLast post
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