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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.
Regarding your question, if there is a legal requirement in Europe to somehow report/declare MI collection in place, the answer is no. You do not have to declare that you have a Medical Information system in place. However, as you have stated it is a legislative requirement for the marketing authorization holder to establish a scientific service in charge of information about the medicinal products placed on the market.
Please also refer to the European Federation of Pharmaceutical Industries and Associations (EFPIA) for additional guidance concerning other considerations for a scientific service.
Website:https://www.efpia.eu/media/676434/220718-efpia-code.pdf
We do hope this helps.
Kind regards
PIPADear 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 accept our apologies for the delay in replying. PIPA has an Audit and Inspection Readiness Checklist under the section Medical Information on their website. You can use the checklist to perform an internal gap analysis prior to the audit, so you know you are audit ready.
In terms of what other topics are traditionally addressed within audits, this varies from company to company but we would choose to look at:
– If any of the medical information activities are outsourced to a vendor, what oversight does the company have?
– Review of the agreements between the company and the vendor
– Translation vendors, if used
– Metrics & KPIs used for oversight both externally (Vendor) or internally
– Who is responsible for creating and updating the Frequently Asked Questions (FAQs) & Standard Response Letters (SRLs), how these are monitored
– Validation of the med info database
– Review of labelling information
– Personnel access to SmPcs & PILs to ensure the current and up to date version used
– Review of social media activities
– Review of data privacyThis list is not exhaustive so please do refer to the MI checklist for further assistance.
Kind regards
PIPADear 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 serviceYou 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
PIPADear 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
PIPADear PIPA Member,
Please accept my apologies for the delay in responding to you. Regarding your question about understanding the need for a live chat/chat bot in addition to other existing platforms, PIPA will be hosting a Medical Information webinar on 8th July which is specifically discussing chat bots.
The webinar is free to members and the link to the booking is here:
https://pipaonline.org/event/pipa-live-mi-webinar-2/We hope this webinar answers the questions you have.
Kindest regards
PIPA
