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Viewing 15 posts - 1 through 15 (of 24 total)
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  • in reply to: Global Medical Information Set Up #45031

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    There are many different models adopted by companies, these include a partial Medical Information (MI) service which is performed both in-house and externally for example; responding to MI enquiries (in-house) and the rest of the service for example; handling of Adverse Events (AEs) & Product Quality Complaints (PQCs) to an outsourced service provider.

    Others use the Full service Provider model where everything is outsourced which includes:
    – Handling of medical enquiries
    – Handling of AEs & PQCs (may not involve the collection of the product), the company usually performs the investigation into the complaint
    – Handling of Frequently Asked Questions (FAQs) and Standard Response Documents (SRDs), this involves tracking, version control and archiving of the superseded versions
    – Develop a response to the enquirer using code of practice requirements (UK uses the ABPI code)
    – Provides an out of hours service

    You will also find in other organisations that global MI is predominately handled by HQ and this information is then filtered down to the affiliates, these may then be slightly adapted to incorporate legislative and code requirements which is performed by the affiliate with the overall approval of global HQ. In this situation, the affiliate would be responsible for maintaining their own SOPs but to ensure that they align with global SOPs. Global would also manage all FAQs & SRDs.

    We do hope this has helped.

    Kind regards
    PIPA

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    Unfortunately, no one within the Committee are unable to advise on this, we would therefore advise that you seek further clarification from the
    ICH guideline E2B (R3) – questions and answers document

    We apologise for not being to provide guidance on this occasion.

    Kind regards
    PIPA

    in reply to: Veeva Vault documents management #44962

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    Although there is no specific information available on this topic that we are aware of, most companies would align the use of Veeva Vault with their current working practices around document creation, approval, retention and updating. However, we would recommend that you reach out to Veeva Vault who should be able to provide a degree of guidance based on what they have assisted other companies to do.

    We do hope that this has helped.

    Kind regards
    PIPA

    in reply to: Vitamins, Minerals and supplements clinical Reporting #44798

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    Unfortunately, there is no one within the PIPA Committee who work in this area. Therefore, we would advise that you refer to the below links for further advice:

    https://food.ec.europa.eu/index_en

    https://www.food.gov.uk/business-guidance/food-supplements

    Kind regards
    PIPA

    in reply to: PV management Software #44799

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    There are many solutions such as:
    Oracle Argus
    ARISg
    TrackWise
    PV247
    Reportum

    Unfortunately, we are unable to state which ones are the most cost-effective options. Argus & ARISg are the most commonly used Pharmacovigilance systems for the intake and reporting of ICSRs. We would therefore advise that you contact one of the above to see which solution would suit your company.

    Kind regards
    PIPA

    in reply to: UK PSMF #44755

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    I will be sure to pass on your comments to the PSMF Working Party.

    Kind regards
    PIPA

    in reply to: Due Diligence #44440

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    Please see the link to the MHRA guidance document on Pharmacovigilance Procedures: https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures/guidance-on-pharmacovigilance-procedures

    This document will provide you with all of the considerations required when conducting Pharmacovigilance activities in the UK with a marketed product.

    Kind regards
    PIPA

    in reply to: EU QPPV UK #44017

    Dear PIPA Member,

    Unfortunately, no one on the committee has had to do this before therefore, we are unable to advise further.

    Kind regards
    PIPA

    in reply to: UK PSMF #43778

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    The obligation on the MAH to maintain and make available a PSMF is provided under section 182 of the Human Medicines Regulations 2012 (as amended) and therefore covers medicinal products only. It is however, worth considering whether the third party contract covers a combination of cosmetic/device and pharmacovigilance services as this may bring the contract into scope of the PSMF.

    Kind regards
    PIPA

    in reply to: ICSR reporting to MHRA post Brexit #42291

    Dear Member

    Thank you for your query.

    Please note that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as

    As per the guidance titled: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority, paragraphs VI.C.2.2. Responsibilities of the marketing authorisation holder in the EU and VI. Appendix 1 Process for follow-up of ICSRs, follow up reports are required by the licensing authority.

    Please follow the link below:

    Modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders (publishing.service.gov.uk)

    Kind regards

    PIPA

    in reply to: Updating XEVMPD for UK MAs to the country code XI #42286

    Dear Member

    Thank you for your query.

    Please note that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.

    No update has been provided by the MHRA regarding Q1: Updating XEVMPD for UK MAs to the country code XI. Does the MAH, QPPV, and PSMF associated with the product entry need to be established in NI, or can they be in GB?. Should you wish to contact the MHRA for further clarity, you can email them via pharmacovigilanceservice@mhra.gov.uk with urgent questions.

    Kind regards

    PIPA

    in reply to: MA and Signals #42276

    Dear Member

    Please note that the response to your query represents the views and suggestions of the PIPA Committee Members and are intended as guidance. Please also refer to guidelines and your own company procedures.

    As per GVP Module IX Signal Management, The marketing authorisation holder in the EU should continuously monitor the safety of their medicinal products and inform the authorities of any new information that might have an impact on the marketing authorisation.

    We hope this helps.

    Kind regards,

    PIPA

    in reply to: Biocide reportability #42257

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to pharmacovigilance regulatory legislation, guidelines and your own company procedures.

    Dear PIPA Member,

    Thank you for your enquiry regarding Biocide reportability.

    For information, please revert to the HSE website to locate the different classifications by following the link here: https://www.hse.gov.uk/biocides/eu-bpr/product-types.htm

    For legisalative guidance, please go to The Review Regulation (Regulation EU No. 1062/2014) of the EU Biocides Regulation 528/2012 (EU BPR) was published in the Official Journal of the European Union on 10 October 2014 and enters into force on 30 October 2014.

    It repeals the Fifth Review Regulation (Regulation EU No. 1451/2007) of the Biocidal Products Directive 98/8/EC (BPD). Guidance is being updated following Brexit.

    For the Notification of unexpected or adverse effects, please go to the following link: https://www.hse.gov.uk/biocides/eu-bpr/product-authorisation-overview.htm for further reporting information.

    We do help the above helps with your enquiry.

    Kind regards

    PIPA

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to pharmacovigilance regulatory legislation, guidelines and your own company procedures.

    Dear PIPA Member,

    Thank you for your enquiry regarding third party agreements.

    In response to your enquiry, the most conservative approach would be that all safety (medicinal and device) should be shared equally between both parties, you would need to select what is relevant for the PV system (ICSR, product quality and aggregate reporting etc.) according to their local regulations.

    The important part from a PV drug perspective is that the EU laws expect that drug experiences globally are taken into account when looking at the risk benefit of its product.

    Therefore generally, the EU MAH would expect to hear of adverse events occurring with the product in territories where the product operates regardless of whether it is a drug or device in those areas.

    Of course, the other way round, the device territories will not expect the depth of information the drug territories expect, but device vigilance regulations are now getting stricter worldwide and some expectations would be there too.

    It is very important that whatever safety arrangements are agreed upon are detailed exhaustively in the contracts.

    I do hope this answers your query.

    Kind regards

    PIPA

    in reply to: MHRA guidance post transition period #42246

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to pharmacovigilance regulatory legislation, guidelines and your own company procedures.

    Dear PIPA Member,

    Thank you for your enquiry regarding the guidance following the end of the transition period concerning the UK PSMF & the UK QPPV role.

    Today (4th September), the MHRA published new guidance concerning the legal obligations of the QPPV & PSMF as from 1st January 2021.

    I can confirm that both the QPPV and PSMF need to be established for the UK and is a legal requirement as from 1st January 2021.

    The guidance states that for all UK Marketing authorisations (MAs), including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder (MAH) must have permanently and continuously at its disposal a QPPV who resides and operates in the EU or the UK, and is responsible for the establishment and maintenance of the pharmacovigilance system.

    This is provided for by regulation 182 of the Human Medicines Regulations 2012 (as amended).

    For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the qualifications and responsibilities of the QPPV> that are outlined in Article 10 of the Commission Implementing Regulation EU No 520/2012 (CIR) will remain unchanged.

    https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-from-1-january-2021?utm_source=487d5bda-3862-4d7a-8aa4-0d7a19d6f8c3&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

    I do hope this helps in answering your query.

    Kind regards

    PIPA

Viewing 15 posts - 1 through 15 (of 24 total)