EU QPPV and Deputy QPPV
The Guideline on good pharmacovigilance practices (GVP) Module 1 – Pharmacovigilance systems and their quality systems, states that as part of the pharmacovigilance system, the market authorisation holder must have permanently and continuously at its disposal, an appropriately qualified person responsible for pharmacovigilance in the EU (EU QPPV).
Case Study
The Request:
A world-class global Pharmaceutical company appointed IntuVigilance as their EU QPPV and PV office. The client wanted support with MA transfer; Eudravigilance and Article 57 updates as well as data transfer into our in-house safety database.
The Task:
The task demanded a robust and tactical handover process with the previous EU QPPV, manoeuvring a steep curve to prioritise surveillance activities and at the same time, ensure that regulatory compliance was maintained for all APIs, per Good Pharmacovigilance practice (GVP).
One API had a PSUR due almost immediately following transfer. All the APIs had to be thoroughly reviewed for their Risk Management Plans, Compliance metrics, Literature Monitoring activities and spontaneous reporting metrics. At the same time, changes had to be initiated with Eudravigilance and Article 57 to ensure a smooth and prompt transfer of EU QPPV and MAH details within the system. Local literature monitoring activities had to be transitioned from existing local vendors, to IntuVigilance’s own preferred bank of vendors.
A gap analysis was performed per API. Handover checklists were meticulously prepared to cover each of the responsibilities of the MAH as defined within GVP. Clear and concise communication with the previous EU QPPV and our Client during the transfer process ensured that all of the elements of their PV System were seamlessly transitioned.
Our dedicated Project Management team outlined a Data transfer plan with the previous PV provider, engaging our IT team in the discussions. We prepared a robust, logical, step-by-step transfer process that allowed data transfer to occur smoothly. Post-transfer reconciliation proved how successful our process map had been during an otherwise extremely challenging time.
Conclusion:
Transparency, clear communication, robust handover checklists, transition plans and in-depth knowledge of handling this kind of work made for a very satisfied customer.
Local QPPV/ Named Safety Contacts
(NSC) across global territories
Competent authorities in Member States are legally provided with an option to request the nomination of a pharmacovigilance contact person at national level reporting to the EU QPPV. A contact person at national level may also be nominated as the local QPPV. Member States that do not stipulate a local QPPV would require an NSC to cover local surveillance activities. Local QPPVs are also mandated in national legislation within certain third countries.
Case Study
The Request:
Our client, an MAH (SME status) with a centrally authorized product is obliged to comply with GVP and national EU requirements to register local QPPVs across EU member states. The product is not yet marketed in the EU.
The Task:
Identify and separate the countries that require a local QPPV versus those that need a NSC. IntuVigilance has a pool of local QPPV and NSC partners who are continuously assessed and qualified via our stringent pre-qualification and auditing procedures. Our local QPPVs and NSCs are highly skilled PV personnel, who regularly support our clients in this service. Local requirements include registration with local authorities, a 24/7 availability, and communication with national authorities, local surveillance activities and regular contact with the EU QPPV. Local QPPVs and NSCs are supplied with named back-up personnel in place.
Conclusion:
Local QPPVs and NSCs are not a ‘nice to have’ but an obligation of authorisation within the EU member states. Whilst it was recognized that the MAH’s product was not yet launched onto the EU market, a certain amount of surveillance activity was undoubtedly necessary as a pre-requisite of authorisation in the EU.
Scientific Literature Monitoring
Utilising our ‘state-of-the art’, deep mining tool, we have an established literature monitoring process that covers over 12 literature databases including PubMed and Embase, providing de-duplicated, unique results in an exceptionally time-efficient and coherent manner.
Case Study
The Request:
Our client, an MAH with a product in rare disease, has awarded full pharmacovigilance service provision to IntuVigilance. This includes global as well as local literature monitoring activities across EU member states.
The Task:
Utilising our state-of-the-art literature surveillance tool, IntuVigilance defines literature-monitoring activities per its internal procedures and captures the process in a Safety Management Plan designed for the project.
With the tool available to us we:
- Monitor literature to identify and retrieve ICSRs of adverse events and special situations.
- Create searches as the basis for collating articles for the periodic safety update report production, identify relevant studies, as well as those reports of events that do not qualify for reporting.
- Identify new and significant safety findings, that may not be found by a search constructed specifically to identify individual cases.
- Identify relevant and applicable, information on other active substances of the same class and therapeutic areas.
Conclusion:
Literature monitoring is a mandatory requirement in the EU and is identified as one of the sources of safety information for a given product(s). Identifying the correct search strategy is critical to ensuring that the net is cast wide enough to collect any potential article or journal pertinent to the given product(s). Confidence in your search strategy automatically imbibes confidence in your safety surveillance activities within this service area.
Pharmacovigilance
System Oversight
The PSMF is described in GVP Module II. It is a modular document that outlines the various aspects of the pharmacovigilance system of a Marketing Authorisation Holder (MAH). The document must be maintained in an up to date state and can be requested by a competent authority within a 7 calendar day deadline for delivery.
Pharmacovigilance
System Oversight
The PSMF is described in GVP Module II. It is a modular document that outlines the various aspects of the pharmacovigilance system of a Marketing Authorisation Holder (MAH). The document must be maintained in an up to date state and can be requested by a competent authority within a 7 calendar day deadline for delivery.
The document must be maintained in an up to date state and can be requested by a competent authority within a 7-calendar day deadline for delivery.
As specified in GVP Module II The structure of the PSMF is stringently controlled and must contain the following sections on the:
- qualified person responsible for pharmacovigilance (QPPV)
- organisation structure of the MAH
- the sources of the relevant safety data
- computerised systems and databases
- pharmacovigilance processes
- pharmacovigilance system performance
- quality system
Additional annexes are also required, and their content must be meticulously documented for compliance.
Pharmacovigilance
and Drug Safety Operations
An integrated (E2B), case processing and expedited reporting service utilising our own dedicated safety database or our clients’ systems.
Our legacy-data transfer service involves dedicated IT subject matter experts to manage all of the pre-and post-migration activities in compliance with regulations.
Pharmacovigilance
and Drug Safety Operations
An integrated (E2B), case processing and expedited reporting service utilising our own dedicated safety database or our clients’ systems.
Our legacy-data transfer service involves dedicated IT subject matter experts to manage all of the pre-and post-migration activities in compliance with regulations.Producing Safety Management Plans alongside Reconciliation and Communication Plans to ensure a smooth start-up of clinical trial as well as post authorized projects.
Dedicated project managers oversee start up, maintenance and completion phases with continuous client interaction.
Standard Operating Procedures
Standard Operating Procedures are a mandatory requirement within any self-respectng Quality Management System. Our subject matter experts conduct gap analyses, whilst producing and maintaining our clients’ SOP suites. Training on SOPs and managing training curriculae forms part of the package.
Case Study
Background:
Having an appropriate suite of key Standard Operating Procedures (SOPs) is one of the corner stones of an effective Pharmacovigilance Quality System as which is a requirement of GVP module I.
The Request:
An organisation with a new Market Authorisation with no SOPs covering Post Marketing activities approached Intuvigilance to assist with identifying what SOPs were required to ensure core Pharmacovigilance (PV) tasks are conducted in a compliant manner and that the Market Authorisation Holder (MAH) have an effective and compliant PV Quality System in accordance with GVP Modules.
The Task:
To conduct a gap analysis on the MAHs current position and identify the additional procedures required to complete an appropriately detailed suite of SOPs tailored to the organization.
Conclusion:
An overview of the required PV SOPs was created with reference to all the GVP Modules, ensuring the list provided was specific to the size of the organization, core PV tasks and any additional PV activities relative to the MAH and the product.
Audits and Inspections
Partner audits are an integral and mandatory requirement for a Market Authorisation Holder. We provide trained experts to plan your audits, conduct and report findings in a cost-effective manner. Our Inspection-readiness programme applies tested methods to help produce effective Inspection outcomes.
Audits & Inspections
Audits and Inspections in the PV universe is not a new concept with the MHRA PV Inspectorate being established in 2004, although, the focus on the PV quality System has increased in the introduction of the new GVP modules in 2012 making the risk-based approach now part of legislation.
From the most recent MHRA metrics (2015/16) it can be established that from the five overall the topic areas representing the largest proportion of inspection findings in this period one area that continues to emerge is findings in the quality system. This includes, auditing of the PV system, CAPA Management, Procedural Documentation and failings in the overall quality management process.
IntuVigilance adopts a risk-based approach to their internal auditing schedule and that of their vendors in accordance with legislation:
- Directive 2010/84/EU amending Directive 2001/83/EC
- Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2001
- Commission Implementing Regulation (EU) No 520/2012 Article 13
- GVP Module IV – Pharmacovigilance Audits
Training
IntuVigilance offers one-off, on-going and new training to ensure that our customers are consistently on top of changing PV requirements. We offer customisable training packages and assist with developing training material to suit all levels.
Case Study
Background:
GVP module I states, “all personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)”. IntuVigilance is committed to providing comprehensive training to both PV personnel and non-PV personnel.
The Request:
An established Market Research organization with an out of hours call centre required a comprehensive PV training programme designed for their non-PV staff.
The Task:
To design a bespoke package to train call centre operatives in the identification of Adverse Events, Adverse Reactions and Special Situations and Medical Information.
This involved creating a bespoke training package for individuals with little or no experience in pharmacovigilance to ensure they had an acceptable level of understanding without overloading them with technical information and jargon. As these operators would be first line for out-of-hours enquiries from customers/patients/healthcare professionals, our bespoke training programme was customized to ensure an in-depth, deep dive into drug safety and PV, complementing the basic PV training that we routinely provide to healthcare professionals, CRAs and MAH staff, along with medical information and call handling training. Suites of Standard Operating Procedures to accompany this training were also prepared.
Conclusion:
IntuVigilance prepared material that not only covers out-of-hours services, but also ensures that this group of non-PV personnel comes away with an in-depth understanding of the essence of drug safety and PV. A robust set of guides, (FAQs, instructions, scripts, etc.) were prepared to arm this group with everything they would need to confidently deal with this out-of-hours service.
Regulatory Intelligence Database
Global country requirements form the basis of everything we do within drug safety and pharmacovigilance. Knowing the legislation in concerned countries, ensuring that you use the most current information and keeping on top of changing legislative requirements is a challenge across the Industry. IntuVigilance is forging the way with a cloud-based solution, bringing Compliance, Speed, Time and Cost-Efficiency to your desktop or mobile device.
Case Study
The Request:
A busy CRO looks to outsource its regulatory intelligence collection to IntuVigilance, due to resource constraints and absence of expertise in managing this activity in-house. It has a fixed budget and a defined number of countries that require oversight both within clinical trials and post authorisation activities.
The Task:
IntuVigilance has developed its own unique mechanisms for the collection, assimilation and verification of regulatory intelligence information across ISO countries. Our system offers clients freedom to access and download information as needed.
IntuVigilance proposed to handle this particular request for co-ordinating intelligence gathering across 200 authorities using its in-house system, with monthly update reports to the client. Keeping our client’s budget in mind, IntuVigilance approached this proposal in a way that not only met the client’s expectations but aligned with their objectives of quality and compliance.
Conclusion:
Regulatory intelligence information provides the necessary tools to conduct compliant expedited and non-expedited activities. Whilst there may be a number of different methods used within the Industry, not all are efficient nor are they accurate or timely. The collection of pertinent information relies heavily on who you seek this information from and how their expertise in PV or drug safety. The quality of information gathered in this way depends entirely upon the robustness of the chain of command. In return, quality, compliance and effectiveness of expedited and non-expedited reporting is directly impacted by any weak link within that chain. IntuVigilance, through decades of experience in this field, provides its clients a robust, time-sensitive and interactive platform on which to base compliant PV and drug safety activities.
Peripheral Services
Our qualified partners across the world provide a number of peripheral services to complement our offerings.
Regulatory Affairs
Pre-marketing Activities
Post-marketing maintenance
Regulatory Project Management
Medical Writing
Non-Clinical and Clinical Writing
Regulatory Writing
Scientific and Technical Writing
24/7 Medical Monitoring Services
Dedicated team of physicians
State-of-the-art technology
Call-handling and document management system
QA Services
Specialist GCP and GMP services
Audits, Gap Analysis, Due Diligence
Training and QP Services
Peripheral Services
Our qualified partners across the world provide a number of
peripheral services to complement our offerings.