International Pharmacovigilance Day

Abstract available soon

The rapid globalization of good Pharmacovigilance Practices (GVP) has resulted in regulatory authorities expanding the level of their pharmacovigilance (PV) requirements to align with the existing European Union Good Pharmacovigilance Practices (EU GVP). These requirements include the Pharmacovigilance System Master File (PSMF) tailored to meet individual country/regional specific requirements.

Since the introduction of the EU GVP Module II guidance in 2012, which provided a framework that allowed varying organizational structures of marketing authorization holders (MAHs), the concept of the PSMF has evolved in countries/regions outside of the EU over the years, creating challenges related to maintenance and production of a PSMF (local or regional). It is therefore imperative that processes are put in place to overcome these challenges because through the production and maintenance of the PSMF, be it local or regional, the MAH and the non-EU local/regional QPPV should be able to verify if the PV system has been implemented in accordance with specified regulatory requirements and compliance.

As more and more health authorities/regulators both in and outside the EU increasingly expect the QPPVs to have oversight of all activities impacting PV, not just core PV activities, It is important to note that a compliant PV system requires effective interfaces with various stakeholders. E.g., regulatory affairs, quality assurance, product quality, medical information, etc. Hence, the QPPV must implement best practices to ensure adequate oversight of the PV system under their responsibility.

For regions outside the EU, e.g.  Latin America (LATAM) and the Arab region, the alignment of the local/regional PSMF with company`s EU or global PSMF is essential to ensure consistent information is delivered to regulatory agencies/inspectors globally. Also, this alignment will enable the non-EU local/regional QPPVs have adequate oversight of their local/regional PV systems and awareness of any updates on the global PV system that impacts the non-EU PV systems.

In the early 1990’s, mostly GCP and GMP inspections included aspects of Pharmacovigilance such as SAE management and associated activities. Although Pharmaceutical Companies were constantly preparing for PV Inspections, Health Authorities conducted limited Pharmacovigilance inspections which were mostly for new approvals or for-cause. With the coming of Volume 9A, systematic inspection programs were triggered by some Health Authorities (HA) such as ANSM (France), MHRA (UK), AIFA (Italy). MHRA then put in place a risk assessment questionnaire that pharmaceutical companies were expected to complete, those who did not complete were automatically on a higher inspection risk. Based on the analysis, MHRA conducted routine inspections mostly every three years, of course triggered inspections were also conducted. Other Health Authorities still conducted limited Inspections due to limited internal resources and training. The FDA did conduct CDER inspections under its BIMO Compliance programs. In Australia, Middle-East, LATAM, and Eurasia PV inspections were still not being conducted.
With the coming of the GVP in 2012, and the roll-out of Module III the Inspection conduct in the EU intensified. Obligations were laid out not just to MAH’s but also to the national Health Authorities expecting them to have detailed inspection programs, the types of inspections were better defined into routine/ for cause, pre-post authorisations, announced/ unannounced, re-inspections etc. EMA, PRAC, CHMP, European Commission also took a central role in Inspections working together with the national HA’s. The Rest of world followed, with implementing the GVP in Arab Countries, Eurasia, and countries like Japan (PMDA) and Australia (TGA), Health Canada also setup their Inspection programs. Several national European Health authorities started to systematically roll out questionnaires to pharmaceutical companies to help them make a risk assessment for their Inspection program such as ANSM, BfArM (Germany), IGJ (Netherlands), OGYEI (Hungary) etc. PV Inspections in the USA were defined as Post marketing drug experience (PADE) focusing on standard PV topics of case collection or Risk Evaluation and Mitigation Strategies (REMS) Inspections focusing on risk minimization or mitigation activities laid out during drug approval.
Over time, the kind of inspections being conducted has changed. E.g. MHRA now has a revised inspection model with four types of Inspections: Routine PV, Routine risk management and safety communication, additional risk minimization measures (aRMMs) and Non-Interventional PASS. The COVID 19 pandemic also influenced remote Inspection conduct. Currently Inspections are done either remotely, on-site or a mix of both. Inspection findings are now shared by HA’s with each other and metrics and trends are shared with the public.
In the past, limited Pharmacovigilance audits were conducted by pharmaceutical companies, mostly of the vendors who undertook key tasks in case management etc. Although, Vol 9A had some requirements clearly stated for conduct of PV Audits, the requirements for a risk-based audit program with an audit strategy and tactical and operational planning for audits kickstarted with coming of GVP Module I and IV. Pharmaceutical companies in Europe then setup a PV audit universe defining clear entities for audits (vendors, systems, partners, affiliates, IT systems, special programs) and conducted an ongoing and annual analysis based on risk criteria for the various entities.
Over time however additional entities have been included into the audit universe such as for a PASS program the tool and systems, vendor, site, documents also need to be audited. Market research vendors, or vendors managing patient assistant programs now form a part of the audit universe and must be audited.
Companies have been required to setup separate units within Quality assurance for PV audits and a resource pool of trained PV auditors needs to be developed.
The type of findings identified has also matured over the years. Although typical case processing related findings (collection, reporting, follow-up, pregnancy) are still identified, observations related to reference safety information management, risk effectiveness checks and minimization measures are seen more and more. Quality management system associated gaps continue to be seen in procedures, audits and CAPA management. The differences in legislation between countries has also been a challenge for pharmaceutical companies to implement a harmonized process across the organization, so one size does not fit all.

Abstract available soon

Abstract available soon

Have you ever thought that the International Pharmacovigilance Day could also be International (Pharmaco)vigilance or even International Vigilance Day?
The purpose of this presentation is not to change the scope of the conference, but to further broaden the horizon of vigilance to other product safety categories.
Pharmacovigilance is responsible for monitoring the safety of medicinal products for human use. But is it the safety of medicines only that should be monitored and assessed? Can’t humans or other animal species gain benefit or be harmed by non-medicinal products?
Hence, the primary concern is again about safety. Medical devices, diagnostics and Healthcare IT (Materiovigilance), cosmetics (Cosmetovigilance), food supplements and nutritional products (Nutrivigilance), and animals’ drug safety (Veterinary pharmacovigilance) are nowadays well-regulated although they are subject to a different regime than medicinal products. The basic principle of these types of vigilance is still ensuring a safe use of product, updating information and taking all measures required so that this never fails. However, there are several differences between the surveillance expected for medicinal products intended for human use versus a veterinary drug as well as between medicinal products and non-medicinal ones. Even vaccines and biologics, a diverse group of medicines, are governed by specific requirements.
The presentation will summarize the basic requirements that a company needs to meet for all its products on the market to ensure safety and compliance, and reduce risks.

Abstract available soon

Abstract available soon

During this interactive session, participants will be divided in groups and will have the possibility to discuss about one specific topic, guided by an expert chair. After 30 minutes, groups will change and face a different subject.

The list of topics will be announced soon.

At the end of the discussion, everybody will come back to the plenary session and each moderator will sum up the main points suggested by the groups.

This year we are looking back to 10 years of experience with the so-called pharmacovigilance legislation that came into force 2012. The world of pharmacovigilance has substantially changed since that time, and will further evolve in the future. It is time to take stock and to reflect upon how pharmacovigilance would or should look like in 10 years from now. Promising developments are ongoing as regards the availability of big data with advanced analytical approaches or new technologies including artificial intelligence. They will become important tools in pharmacovigilance in the near future but the question remains whether they are to be considered real game changers.
New opportunities in terms of technical advancements will require the adaptation of the regulatory framework including the legislation, not only in Europe but also from a global perspective. Collaboration will be key – between regulators, industry and other stakeholders including academia, but also between the European regulatory network and the rest of the world. Last but not least the pandemic has shown both the strength of the current system and the challenges we are all facing. It is therefore essential to benefit from the lessons learnt to be prepared for any future scenario.