Nordic Pharmacovigilance Day - Programma

Abstract available soon

Automation, and recently not least in the form of artificial intelligence, is subject to investments for most Pharma companies and Regulatory Agencies today. It is, however, not trivial to implement advanced automation technology effectively across the PV process landscape, i.e. to be able to harvest the potential value. In this session, we will go through learnings from the recently completed, PV-focused “AI Data Analyzer” public-private initiative and talk about how to get the most value of machine-derived data in the actual processing of ICSRs, signal detection etc. without compromising compliance. Also, it will be argued why some of the automation gains also has potential even if you are only processing smaller case volumes.

The session will be co-chaired by Wasim Anwar and Doris Stenver

Since the release of the Medical Device Regulation (MDR) 2017/745 the manufacture of medical devices and drug-device combination products have scrambled to obtain MDR CE-certifications and become compliant with the new regulation. In addition, the current legislative trend reveals an expectation of more holistic analysis and safety reporting for the competent authorities when it comes to the drug device combination products. The new MDR Periodic Safety Update Report (PSUR) requirement for medical devices is a platform from which from the legislators to have a better overview of the safety and performance of marketed medical devices and this presentation will give a brief overview of:

• The requirements of the PSUR for medical devices
• The current thinking of the Medical Device Coordination Group (MDCG) expert group on the topic
• The interlinkage between the PSUR and the other processes needed to establish a successful PMS-system in accordance with the MDR
• Introduction of the International Medical Device Regulators Forum (IMDRF) coding system and its usage in the PSUR
• The effect of the MDR on drug-device combination products in relation to PSUR
• Current requirements for drug-device combination products for in drug PSUR’s or similar documents.

The UK left the EU on 31 January 2020 and the transition period ended on 31 December 2020. Initially the UK remains very highly aligned with the EU regulatory framework, free to take independent decisions in relation to Great Britain whilst remaining aligned with EU decisions in respect of Northern Ireland. This session will provide the insight of a UK regulatory authority inspector into the operation of pharmacovigilance now that the UK has left the EU and the approaches that industry has taken in implementing the updated requirements

This presentation will cover the regulatory landscape and practical considerations related to outsourcing of pharmacovigilance activities. From several years of experience working within the pharmacovigilance area in either contracting organizations or vendors/customers, Ea will highlight the present opportunities when outsourcing pharmacovigilance activities, as well as the potential pitfalls your company should be aware of. Outsourcing of pharmacovigilance activities can be a great opportunity for companies looking to fill competency gaps amongst their own staff. Through outsourcing, companies can hire the best experts for specific tasks without the hassle and expense of hiring and onboarding senior staff members. Companies should be cautious in selecting the right partner since the ultimate responsibility for pharmacovigilance lies on them. This includes due diligence to ensure you have proper procedures and contracts that cover all aspects of the partnership, as well as understanding how you can maintain a state of control when outsourcing to protect your company and its data.

This presentation will provide examples of how a collaboration between a Global patient safety unit in Headquarter and affiliates can look like in a small-size/mid-size pharmaceutical company. It will describe how the Global unit and Global/EU QPPV are in contact with the affiliates and keep oversight of PV activities performed locally.

The presentation will cover examples from affiliates where local PV activities are outsourced and handled by a global or local vendor and affiliates where local PV activities are handled internally. Considerations about centralized handling of local PV activities vs. local handling will be shared along with the challenges and solutions that have been experienced related to centralization

The session will be chaired by Wasim Anwar