European Medicines Agency

EudraVigilance registration manual

Retrieved on: 
Wednesday, April 3, 2024
Scroll, University, Data analysis, Patient, Account, Organization, MAH, Medicine, Manual, MFL, IAM, VAT, Finalize (optical discs), QAT, Competence, Documentation, Letter, Privacy, HQ2, ServiceNow, Environment, Trust (social science), RP, Table, Record, MPR, European Medicines Agency, Restricted area, Yahoo!, Identity management, Change request, Access, Qualified person (European Union), HQ, MMD, Home, Hospital, Research, Service, Network affiliate, Comment, Access management, OMS, Send, MSSO, ISO, Commercial, European, NCA, NCS, Managed services, Next, Document, EMA, PSMF, Language, MedDRA, AMP, Database, ICSR, Figure, EudraGMP, Dictionary, AMPS, Reproduction, Quality assurance, Identity, Virtual, Q2, SME, Change, Importance, Management, Security, Name, Location, Sponsor, Completeness, ID, 24 Hours, User, Vaccine
Key Points: 

    EudraVigilance registration documents

    Retrieved on: 
    Wednesday, April 3, 2024
    Community, Reproduction, EV, EudraVigilance, Annex, Letter, Regulation (European Union), European Parliament, Qualified person (European Union), Regulation, RP, OMS, EMA, Commercial, Request, Law, Marketing, European Medicines Agency, MAH, Council, EEA, Service, European, Clinical trial, ID, User, Register, Security printing

    Table of contents

    Key Points: 
      • Table of contents
        Pre-requisites .............................................................................................. 3
        Registration of the headquarter for Marketing Authorisation Holders
        (MAHs) ........................................................................................................ 3
        Registration of the headquarter for Commercial and Non-commercial
        sponsors ...................................................................................................... 4
        Registration of the headquarter of National Competent Authorities ............ 5

        EudraVigilance registration documents
        EMA/503894/2018

        Page 2/5

        Pre-requisites
        ?

        User registration in the EMA Account Management Portal ? see section 2.1 of the EudraVigilance
        Registration Manual.

      • ?

        Registration of the organisation in the Organisation Management System ? see section 3.3 of the
        EudraVigilance Registration Manual.

      • ?

        Request of the role, as applicable, ?EV MAH EU QPPV? or ?EV NCA Responsible? or ?EV CS/NCS
        Responsible? by the user via the EMA Account Management Portal ? see section 5.2 and Annex
        1 of the EudraVigilance Registration Manual.

      • ?

        Once the role has been requested in the EMA Account Management Portal, a Service Desk ticket
        should be raised to the Registration team, quoting the Request ID number and attaching the
        required documents listed below.

      • Registration of the headquarter for Marketing Authorisation
        Holders (MAHs)
        ?

        A cover letter from the headquarters level of the organisation on a company?s headed paper.

      • EudraVigilance registration documents
        EMA/503894/2018

        Page 3/5

        profile who has completed the courses and is related to the respective organisation.

      • Registration of the headquarter for Commercial and
        Non-commercial sponsors
        ?

        A cover letter from the headquarters level of the organisation on a company?s headed paper.

      • EudraVigilance registration documents
        EMA/503894/2018

        Page 4/5

        Registration of the headquarter of National Competent
        Authorities
        ?

        A cover letter on organisation?s headed paper.

    Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

    Retrieved on: 
    Wednesday, April 3, 2024
    Community, Reproduction, Appendix, European Medicines Agency, Patient, Parliament, MAH, Council, Member state, European, NCA, GxP, Legislation, Communication, Comment, Classification, Partnership, Risk, Committee, PSMF, Safety, Calendar, CHMP, State, Documentation, Public, Directive 2001/83/EC, IWG, GVP, Commission, CAPA, Guideline, IO, Computer, PRAC, European Parliament, Registry, Record, Peer review, Language, Collection, Inspection

    Union procedure on the preparation, conduct and

    Key Points: 
      • Union procedure on the preparation, conduct and
        reporting of EU pharmacovigilance inspections
        Table of contents
        1.
      • Record management and archiving ....................................................................... 12

        References ................................................................................................ 12
        Appendix 1 ?Pharmacovigilance inspection report .................................... 13
        Appendix 2- Inspection overview (IO) ...................................................... 14
        Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
        Appendix 4- Classification of inspection findings....................................... 16

        Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 2/16

        1.

      • Guidelines on the interpretation of legislative pharmacovigilance
        requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
        pharmacovigilance inspections.
      • Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
        procedure on the coordination of EU pharmacovigilance inspections.
      • Scope
        This procedure constitutes a guideline in preparing, conducting and reporting national competent
        authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
        Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
      • Those are covered under the Union procedure on the
        management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 3/16

        3.

      • Preparation
        Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
        a pharmacovigilance inspection and prior to inspection conduct.
      • For the selection of involved
        parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
        pharmacovigilance inspections.
      • Announcement communications could include, for example, the

        Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 4/16

        name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 5/16

        ?

        Feedback from other competent authority functions, in particular pharmacovigilance assessors.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 6/16

        ?

        If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
        located off site etc.

      • ?

        Union procedure on the management of pharmacovigilance inspection findings which may impact
        the robustness of the benefit-risk profile of the concerned medicinal products.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 12/16

        Appendix 1 ?Pharmacovigilance inspection report
        Click here for the template.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 13/16

        Appendix 2- Inspection overview (IO)
        Click here for the template.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 14/16

        Appendix 3- Pharmacovigilance inspection outcome sharing
        Click here for the template.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 16/16

    Summary of opinion: Prevexxion RN+HVT+IBD, 13/03/2024 Positive

    Retrieved on: 
    Wednesday, April 3, 2024
    OVO, European Commission, Civil service commission, European Medicines Agency, Committee, Marketing, SPC, UPD, CVMP

    On 13 March 2024 the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Prevexxion RN+HVT+IBD.

    Key Points: 
    • On 13 March 2024 the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Prevexxion RN+HVT+IBD.
    • The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.
    • Prevexxion RN+HVT+IBD is currently authorised as concentrate and solvent for suspension for injection.
    • The variation concerns the addition of a new route of administration: in ovo.

    European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 July 2024

    Retrieved on: 
    Wednesday, April 3, 2024
    Consumer, European Medicines Agency, PCWP, Patient, EMA

    European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting

    Key Points: 

    European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting
    The Patients and Consumers Working Party (PCWP) will hold its plenary meeting on 2 July 2024 in the morning.
    EventHuman
    Date
    Location
    The Patients and Consumers Working Party (PCWP) will hold its plenary meeting on 2 July 2024 in the morning.

    European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, 3 July 2024

    Retrieved on: 
    Wednesday, April 3, 2024
    Health professional, Consumer, European Medicines Agency, PCWP, Party, Health care, Patient, EMA

    European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting

    Key Points: 

    European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
    This meeting brings together the members of the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP).
    EventHuman

    Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

    Retrieved on: 
    Wednesday, March 6, 2024
    Janus, Sorbitol, Marketing, EMA, Doctor of Philosophy, New Drug Application, MAA, Interim analysis, P-value, FDA, Food, Growth, Treatment, INSPIRE, Priority review, PDUFA, Chairperson, Therapy, CHMP, European Medicines Agency, Patient, Private placement, PRV, NDA, Ageing, Pharmaceutical industry

    The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.

    Key Points: 
    • The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.
    • Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval.
    • The Company expects a decision by the EMA in the fourth quarter of 2024.
    • Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.

    Kamada Issues 2024 CEO Letter to Shareholders

    Retrieved on: 
    Wednesday, March 6, 2024
    Acquisition, KMDA, CMV, Hospital, Division, EMA, CSL Behring, Letter, Physician, Critical care, FDA, Technology transfer, Food, Growth, FEV1, AAT, Immunoglobulin G, Safety, University, European Medicines Agency, Food and Drug Administration, Pan American Health Organization, Patient, Plasma, Research, Partnership, Pharmaceutical industry

    The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.

    Key Points: 
    • The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.
    • Looking ahead, we expect the momentum from 2023 to extend throughout 2024, with profitability to be further increased as compared to last year.
    • These significant catalysts are propelling our continued annual double-digit profitable growth with substantial upside potential and limited downside risk.
    • On behalf of the entire Kamada team, we look forward to continuing to support patients and clinicians with the important lifesaving products that we develop, manufacture, and commercialize.

    Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

    Retrieved on: 
    Tuesday, March 5, 2024
    Central nervous system, Quarter, EMA, Focal seizure, Research, New Drug Application, UCB, FDA, Partnership, Food, Part, Quantitative electroencephalography, SCN8A, Tremor, SCN2A, Safety, PPR, European Medicines Agency, CNS, EEG, Pharmacokinetics, Part 1, Patient, Essential tremor, Medicine, Epilepsy, DEE, Trial of the century, NDA, Ageing, Central nervous system disease, Seizure, Pharmaceutical industry

    Fourth Quarter and Full Year 2023 Financial Results:

    Key Points: 
    • Fourth Quarter and Full Year 2023 Financial Results:
      As of December 31, 2023, Praxis had $81.3 million in cash and cash equivalents, compared to $100.5 million in cash, cash equivalents and marketable securities as of December 31, 2022.
    • Research and development expenses were $18.4 million for the fourth quarter of 2023, compared to $28.3 million for the fourth quarter of 2022.
    • General and administrative expenses were $9.9 million for the fourth quarter of 2023, compared to $13.1 million for the fourth quarter of 2022.
    • Praxis incurred a net loss of $26.9 million for the fourth quarter of 2023, including $5.7 million of stock-based compensation expense, compared to $41.2 million for the fourth quarter of 2022, including $6.4 million of stock-based compensation expense.

    CymaBay Announces European Medicines Agency Accepts for Review the Marketing Authorization Application for Seladelpar for the Treatment of Primary Biliary Cholangitis

    Retrieved on: 
    Monday, March 4, 2024
    Liver, Child, Marketing, EMA, Ursodeoxycholic acid, MAA, Chemistry, Cirrhosis, Inflammation, FDA, Quality of life, Food, Chief, Conditional sentence, PBC, Risk, European, Health care, Therapy, Fatigue, CHMP, European Medicines Agency, Primary biliary cholangitis, Patient, Itch

    Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment.

    Key Points: 
    • Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment.
    • The study’s primary endpoint measure reflects registrational studies of the current second line PBC treatment authorized by the EMA.
    • In this study seladelpar demonstrated statistically significant improvements in biochemical markers of disease progression and PBC-related pruritus (itch) pre-specified endpoints.
    • “Validation of the European Marketing Authorization Application for seladelpar and the start of the agency’s formal review is an important step forward in seladelpar’s journey to potential approval in Europe.