Nordic Pharmacovigilance Day - Programma

We all know that Pharmacovigilance (PV) is defined as: “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems”.

We also know that to be able to fulfil its pharmacovigilance obligations, a marketing authorisation holder (MAH) must establish and maintain a Pharmacovigilance system that is fit for purpose and designed to monitor the safety of authorised medicinal products and detect any change to their risk benefit balance.

One objective of a pharmacovigilance inspection is to determine that the MAH has personnel, systems and facilities in place to meet their pharmacovigilance obligations – obligations that are applicable to the whole company – not only to the QPPV, the Pharmacovigilance Department or contracted service providers.
This presentation will discuss what may be inspected (during a PV inspection) in terms of personnel and work performed in departments such as medical affairs, regulatory, marketing et cetera.

This session will provide insights on Internal pharmacovigilance activities related to outsourcing, involving the delegation of certain pharmacovigilance functions to external service providers or vendors. It will touch upon the importance of assessments to ensure the effectiveness and quality of pharmacovigilance activities and maintain compliance with regulatory requirements. Moreover, it is important to identify and implement specific agreements to define tools and controls used to ensure compliance, one of the effective tools being pharmacovigilance audits of PV vendors and partners.

It will touch upon pharmacovigilance guideline requirements and the process of audit risk assessment of PV partners based on activities performed and their impact on the pharmacovigilance system. This process is also used to plan the different methods of audit to be used based on risks.

Some audit observations/ case studies around management of safety case reporting, follow-up on safety cases, promotion of medicinal products, sub-contracting activities and controls and GDPR requirements will also be shared in this talk.

Implementing a unified IT platform across multiple departments within a pharmaceutical company brings several advantages. By establishing a single source of truth between regulatory, pharmacovigilance, clinical, and commercial departments, processes can be streamlined, eliminating complexity. Harmonizing data and workflows enhances efficiency, compliance, and collaboration. A single platform eliminates data silos and the need for time-consuming reconciliations, reduces errors, enables faster decision-making, and facilitates cross-functional teamwork.

A unified IT platform enhances compliance with regulatory requirements. By ensuring that all departments operate from the same set of validated and controlled data, the organization can maintain regulatory compliance more effectively. This reduces the risk of non-compliance, improves audit readiness, and safeguards the company’s reputation and market position.

By eliminating redundant processes and data duplication, a single IT platform reduces the administrative burden on employees. Automating workflows and standardizing data formats enable efficient data entry, retrieval, and analysis, saving time and effort. This allows employees to focus on value-added activities.

Whether posting, sharing, tweeting, or pinning, social media platforms attract billions of users worldwide. An increasing number of them seek healthcare advice online, where misinformation propagates in a frenzy — especially in the COVID-19 infodemic.

Against this backdrop, how can we ensure that individuals are met with sound, practical guidance when searching for health-related information online, and how can we tailor social media campaigns to promote medicines safety effectively?

This presentation will examine how medicines agencies and regulatory authorities can pierce the social noise and promote pharmacovigilance messaging.

Utilising a case study of Uppsala Monitoring Centre’s (UMC) annual #MedSafetyWeek campaign, we will investigate how a multi-channel and multi-content approach can lead to social growth and uptake of pharmacovigilance messaging in target audiences. The #MedSafetyWeek campaign sees UMC, medicines regulatory authorities, and national pharmacovigilance centres worldwide join forces to raise awareness of adverse drug reactions.

We will also explore combatting adversity and misinformation when sharing health-related messaging on social media.

In today’s regulatory landscape in Europe (EU), EU Medical Device Regulation (MDR) has replaced the EU Medical Device Directives (MDD), providing a more robust, and thorough regulatory framework that directly applies to each EU member state. The EU MDR emphasizes on safety throughout lifecycle of the device from presenting sufficient clinical evidence that supports General Safety and Performance Requirements (GSPR) for medical devices to maintaining a more comprehensive Post-Market Surveillance (PMS) (including vigilance) to ensure a high level of public health protection including end user and patient safety.

For combination products, EU MDR Article 117 now requires manufacturers of integral drug-device combination products that are to be marketed as medicinal products to obtain a Notified Body Opinion (NBOp) for the device part while complying with relevant GSPR as part of the market authorisation application.

In this talk I will touch upon post-market surveillance requirements for the manufacturers to plan, establish, document, implement, maintain, and update PMS system (including vigilance) in a manner that is proportionate to the risk class and appropriate for the type of device.

The participants will also get insights into what is covered in the PMS system including trend reporting (for when any statistically significant increase in the frequency or severity of non-serious incidents or that are expected undesirable side-effects could have a significant impact on the benefit-risk analysis), Manufacturer Incident Reports (MIRs) for serious incidents, and Field Safety Corrective Actions (FCSA).

In addition, the presentation will also cover device Periodic Safety Update Report (PSUR) introduced by EU MDR, though PSUR is well known in the pharmaceutical industry, it is a new PMS requirement for higher risk medical devices requiring from the manufacturers a more consistent, standardized, and systematic review of all PMS data on their medical devices.

The presentation will give a highlight of the experiences with implementing the EU CTR in Novo Nordisk primarily from a Pharmacovigilance perspective but also from relevant interfacing functions.

The presentation will include background for the EU CTR, recap of main changes with the EU CTR from the PV perspective, how it has been implemented and the initial experiences, challenges and learnings while implementing the new regulation

Managing drug and device safety effectively and efficiently has become more and more challenging as companies face an enormous increase in the number of incoming safety cases. This has created the need for companies to streamline elements of the pharmacovigilance/multivigilance process with automation. And now, automation can be taken to the next level with artificial intelligence (AI), a powerful tool that enables companies to process larger volumes of data, identify signals and cases, and significantly improve the entire safety process.

In this talk you will get better understanding of the role played by AI, whch can help in the planning of its implementation for specific needs and growth rates, including a transition to safety case processing that is increasingly touchless. This transition is best implemented in a phased approach in order to achieve tangible results when adding AI abilities to augment human-based systems. Thus, the conversion of many components of case processing to touchless operation can begin, allowing humans to focus their efforts on the areas that require the most detailed attention.

A SMART approach to a globalized PSMF – or perhaps rather an approach meeting international, regional or national marketing pharmacovigilance requirements?
• How to be Specific on the goal when your EU-based company is required to establish a description of the PV activities handled at the national level?
• How to Measure that you and your company have reached the goal?
• How to make the model Attractive for your company and your partners/affiliates at national level?
• How to do it together -is it Realistic?
Is it likely that you together with your partners at the global, regional, or national level can do it together?
• How to do it Timely? – Do you know the timeline?