Nordic Pharmacovigilance Day - Programma

Even though it has been many years since the introduction of the pharmacovigilance legislation, pharmacovigilance inspections remain an important topic. Being inspection ready as a Marketing Authorisation Holder (MAH) is something we have all heard before, but what does it mean from the inspectorates side?

In this session you will gain knowledge about considerations and preparations for pharmacovigilance inspections from regulators perspective. The talk will provide an overview of planning of inspection programme and individual inspection plans with a focus on:

• Collaboration within the EMA
• Collaboration with assessors
• Publicly available information
• Information pertaining to the individual MAHs present in Art 57.

Understanding  potential areas in scope for an announced inspection will support effective management of resources during the preparation of inspections

MAHs should also be inspection ready. However, the meaning of this mantra has changed over recent years with the increased inspection focus on cross-organisational PV processes and the IT systems upon which the PV organisation relies.

This session will focus on how MAHs should prepare for inspections, how extensive the preparations should be and which stakeholders to involve before, during and after the inspections.

Since the beginning of the COVID-19 pandemic, there has been an unforeseen exposure of medicinal products in the combat against the coronavirus, both therapeutics as well as vaccines. In the end of 2020, the first COVID-19 vaccine reached conditional marketing status in the EU/EEA. An exceptional exposure within a short time frame, in combination with stimulated reporting of suspected side effects, led to an enormous load of individual case safety reports, and consequently, the pharmacovigilance system faced challenges accordingly. With the large amount of data also came the possibility and opportunity to complement the safety surveillance and signal detection activities with register data.

This presentation will give examples of when the signal detection activities have successfully been complemented by register data, in the COVID-19 pandemic setting.

This talk will provide an overview of implementation of the Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management from industry perspective and will provide an outline of the signal management process in a big pharma.

It will also touch upon current state and the challenges for heading into the future for the signal detection, where new local requirements are emerging and new data sources are offering new possibilities and complexities for the signal detection and reporting.

During this interactive session, participants will be divided in groups and will have the possibility to discuss about specific topics.

Key topics are:

1. PV agreement
2. Data privacy
3. Artificial intelligence

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

Part 1  (Jen Markey)

If your company’s PV landscape is similar to most, you do not have just one safety (vigilance) solution, you have many. Some for data & documents, some for communication, reporting, reference libraries, etc. Many different technology solutions that overlap, interconnect and in some cases duplicate effort … and all of these solutions must work seamlessly together and be validated. It’s a complex environment that is increasingly challenging for most companies to manage. This presentation will discuss how to streamline and simplify while increasing transparency and compliance.

Part 2  (Martin Holm-Petersen)

The well-known safety databases were architected decades ago to fix certain problems that are not necessarily central to the PV organization anymore. Pushing for re-thinking, this presentation will consider the following questions:​

• How can we work better with affiliates and partners, without complex and obstructive boundaries?​
• How can we make good use of AI and machine learning, without having to spend an excessive amount of time and money?​
• How do we handle the massive amounts of big data that are becoming available in our every-day processing? ​
• How do we make life simpler with cloud / SaaS technology, while maintaining GxP and security?​

The aim of this presentation is to give some advice for the implementation of GDPR with focus on data minimisation in the handling of individual cases of suspected adverse reactions brought to the attention of the Marketing Authorisation Holder from spontaneous sources. Relevant quotes from the Pharmacovigilance legislation as well as from GDPR will be presented along with recommendations on data flow for individual cases and follow-up, Data Privacy notifications for reporters and patients and record retention requirements.

This presentation will focus on the complexities surrounding the inclusion of PV provisions into agreements with partners who perform tasks which are relevant to the PV system. It will (i) address how detailed such PV provisions should be depending on the specific relationship with the partner, (ii) comment on pitfalls to watch out for during negotiations of PV language / PVAs, (iii) highlight observations from PV inspections and (iv) provide food for thought with respect to PV-relevant changes in EU law. The presentation will also give guidance for negotiations on PV clauses, and why and how to insist on robust PV language which protects the company.