About

It is our pleasure to announce that the well-known Nordic Pharmacovigilance Day conference is taking place on 13 November 2024, in Copenhagen, Denmark. The conference offers a full day of engagement for professionals deeply involved in pharmacovigilance and related activities, as well as being a valuable platform to delve into current and compelling topics including fostering collaboration across various departments and companies.

The primary objective of the conference is to provide delegates with a friendly environment for learning, interaction, active participation, and inspiration. Given the rapidly evolving expectations in pharmacovigilance across diverse areas, the conference agenda will encompass multiple perspectives. This includes viewpoints from regulators, insights from partners and service providers, and case studies from both small and large pharmaceutical companies.

The program will be focused on concrete presentations, real life experiences and useful “take-home” messages, covering  “hot topics”, such as PV oversight, digital media listening, implementation of RMP and RMM, signal analytical tools, combination products, PV system governance and responsibilities from both local and global point of views.

Looking forward to meeting you in Copenhagen for a wonderful day of sharing, training, and networking! See you there!

Scientific Board

  • Wasim Anwar - Vice President & Deputy QPPV - Head of QPPV Office, Global Safety at Novo Nordisk A/S
  • Caroline Susanne Sandström - Head of Global Clinical Quality at Ferring Pharmaceuticals A/S
  • Mette Stie Kallesøe - Head of Pharmacovigilance, QPPV at Hansa Biopharma AB

Who should attend?
The conference program is designed for healthcare professionals or pharmacists working in the pharmacovigilance units in the pharmaceutical industry or regulatory agencies, either as specialists or managers, QPPVs, inspectors and QA personnel including auditors, employees in regulatory affairs units with close relations to pharmacovigilance, vendors and CROs working with patient safety data.

 

Programme
13 November 2024
08.30
09:00
Registration
09:00
09:10
Welcome by the Scientific Board
09:10
09:50
Handling Safety Data from Digital Media
Maria Laustsen Murholm - Compliance Specialist for Digital Health at Novo Nordisk

The use of digital social media and the need to reach customers and gain customer insights have greatly increased over the years. An activity-tailored and risk-proportionate strategy to screen data for safety information is essential for effective utilization of resources, while still fulfilling the applicable PV legal requirements. During the presentation I will describe how do we approach screening and handling of safety information from different types of digital listening and social media scraping activities conducted in Novo Nordisk.

09:50
10:30
Graph Theory in Pharmacovigilance: Enhancing Drug Safety Analysis
Peter Nowicki - Senior Director of Innovation Lab & PV Products at RxLogix

Pharmacovigilance is essential for monitoring adverse drug reactions (ADRs) and ensuring the safety of medicinal products. Traditional methods of data analysis in pharmacovigilance can be limited in handling complex relationships between drugs and ADRs. Graph theory, a branch of mathematics concerned with the properties of graphs, offers a promising alternative approach.

This presentation aims to explore the general application of graph theory in pharmacovigilance, particularly in understanding complex drug-ADR relationships and enhancing the effectiveness of drug safety surveillance systems.

We utilized graph theory to construct and analyze networks of drug-ADR interactions. Data was gathered from pharmacovigilance databases, focusing on reported ADRs and their associated medicinal products. The networks were analyzed using various graph theory metrics such as connectivity, centrality, and community structure to identify significant patterns and relationships.

The application of graph theory facilitated the visualization and analysis of complex relationships in pharmacovigilance data. It revealed additional insights into the interconnected nature of drugs and reported ADRs, identifying key nodes (drugs and ADRs) that play critical roles in the network. This method also helped in detecting clusters of ADRs associated with specific drugs, which might not be evident through traditional pharmacovigilance methods.

Graph theory offers a valuable tool for the analysis of pharmacovigilance data, providing a deeper understanding of drug-ADR interactions. Its ability to represent and analyze complex relationships in a comprehensive manner can enhance the detection and evaluation of drug safety issues. The insights gained from this approach could lead to more effective strategies for managing drug-related risks and improving patient safety.

10:30
11:10
Coffee break
11:10
11:50
PV Supplier Oversight by MAH - Learnings from Inspection
Jeanette Johansson - Pharmacovigilance Inspector at the Swedish Medical Products Agency

It is quite common for a Marketing Authorisation Holder (MAH) to subcontract certain activities within their pharmacovigilance system to a PV supplier. Nevertheless, each MAH retains ultimate responsibility for all parts in their pharmacovigilance system, including the completeness and accuracy of the pharmacovigilance system master file (PSMF). In other words, the MAH can delegate activities but never responsibility and must keep close oversight of the work performed by their subcontractors!
This presentation will discuss anonymised findings from PV inspections in relation to PV supplier oversight by MAH in areas such as:
– qualification, continuous assessment, and audit of PV suppliers
– explicit and detailed agreements
– written procedures relating to the implementation of contracts and PV agreements
– reconciliation of PV-data
– PV-training of suppliers
– et cetera

11:50
12:30
Pre-Qualification of a PV Supplier: Process and Expectations
Janie Willadsen - Associate Director, QA GCP/PV at Genmab

Abstract available soon

12:30
13:30
Lunch
13:30
14:30
Workshop in groups - Navigating the Governance of Global Pharmacovigilance Systems

Join us for an engaging workshop focused on delving into the intricate governance of global Pharmacovigilance (PV) systems. In this session, we will unravel why discussions surrounding PV governance are often overlooked and explore the critical components that shape this vital aspect of drug safety management.

Key Topics Include:
1. QPPV Coverage: Unpacking the role of the Qualified Person for Pharmacovigilance (QPPV) and understanding the nuances of local QPPVs.
2. PV Organization Structure: Analyzing the dynamics of PV organizational structures, including considerations for affiliates, Local Safety Officers (LSOs), and outsourcing models.
3. Case Processing Setup: Exploring strategies for efficient case processing, effective follow-up procedures, and robust documentation practices.
4. Oversight Perspectives: Gaining insights into the level of oversight required from a QPPV perspective and best practices for maintaining regulatory compliance and patient safety.

This workshop offers a unique opportunity to exchange ideas, share experiences, and deepen your understanding of the governance landscape within global PV systems. Whether you’re a seasoned PV professional or new to the field, this session promises to enrich your knowledge and enhance your approach to PV governance. Join us and be part of this essential conversation shaping the future of drug safety

14:30
15:10
Post-Market Reporting for Drug-Device Combination Products in the EU versus US: Challenges faced during Implementation when Device Specific Requirements meet the Pharmacovigilance System
Juan Paolo Granada - Senior Pharmacovigilance Physician at Ferring Pharmaceuticals A/S
Maj-Britt Schmidt Andersen - Medical Devices Intelligence and Compliance Manager in Global Safety at Ferring Pharmaceuticals A/S

Post-marketing safety reporting requirements for combination products in the EU and US are governed by the primary mechanism of action and whether the device and drug components form a single integral product.

In the EU, post-market reporting requirements are determined by the overall regulatory classification, whereas a specific rule on post-market safety reporting requirements have been published by the FDA (21 CFR 4 Subpart B), to clarify reporting requirements for products that combine at least two of the three different components- drugs, biologics, and devices.

This presentation will provide an overview of the regulatory landscape for safety reporting on drug-device combination products as well as highlight the challenges faced during implementation of the regulations.

When attempting to integrate device requirements into a global pharmacovigilance system, the footprint it leaves on the QMS system is significant. Devices bring new vocabulary and requirements that are not part of the classic pharmacovigilance setup such as the concept of similar devices, device malfunctions and reportable events based on a risk assessment rather than actual patient harm.

15:10
15:40
Coffee break
15:40
16:20
Assessing and Enhancing the Effectiveness of Risk Minimisation Measures - Authority's Perspective
Per Sindahl - Senior Pharmacovigilance Assessor at Danish Medicines Agency

The overall aim of risk management is to ensure that the benefits of a particular medicinal product exceed the risks by the greatest achievable margin. This aim is achieved by effective risk minimisation measures (RMMs).

For several decades it has been standard regulatory practice to require evidence of quality, efficacy and safety for medicines before they are made available to patients. Yet, it is only in recent times evidence of effectiveness of RMMs have been required, although effective risk minimisation may be a condition for a positive risk-benefit balance.

Despite existing guidelines and the importance of studies evaluating RMMs, the quality of evidence is often insufficient to determine their impact on patient safety. This has led to a growing consensus among stakeholders for the need for high-quality evidence to guide risk minimisation programs and transform pharmacovigilance into a more effective learning healthcare system. More studies with high-quality is needed to inform regulatory decision-making and enhance the scientific field of risk management.

In this presentation, I will address some of the shortcomings of current risk minimisation evaluation approaches and outline characteristics of effective risk minimisation strategies drawing on new findings from my PhD research and the updated Good Pharmacovigilance Practices (GVP) guideline on RMMs.

16:20
16:30
Closing Remarks by the Scientific Board
Speakers
Wasim Anwar
Info Scientific Board

Wasim Anwar

Vice President & Deputy QPPV - Head of QPPV Office, Global Safety at Novo Nordisk A/S

Wasim Anwar is a medical graduate from King Edward Medical University, Pakistan and holds a PgD in Pharmacovigilance from University of Hertfordshire, UK. He has over 10 years of experience in the field of pharmacovigilance (PV) while working in different biopharmaceuticals companies in various capacities both as a PV professional as well as a leader. Currently he is working at Global Safety, Novo Nordisk A/S as Deputy QPPV and heading up the team of pharmacovigilance experts responsible for supporting and maintaining global oversight and compliance to pharmacovigilance regulations and processes.

Mette Stie Kallesøe
Info Scientific Board

Mette Stie Kallesøe

Head of Pharmacovigilance, QPPV at Hansa Biopharma AB

Mette has an MSc in Pharmacy from the then Royal Danish School of Pharmacy and a MSc in Pharmacovigilance from the University of Hertfordshire, UK. She has profound knowledge of global pharmacovigilance legislation, compliance, impact assessments, pharmacovigilance processes and systems stemming from more than 20 years pharmacovigilance experience from Ferring, Novo Nordisk and LEO Pharma. In her previous positions she has been responsible for case processing for post-marketing and clinical trials, coordinating and providing PV input audits and inspections PV, GCP and GMP areas, for PV intelligence and impact assessments of new legislation, QPPV review and approval of PSURs, ACOs and RMPs, responses to regulatory requests and compliance with GDPR across safety processes. In her current role she Head of Pharmacovigilance, QPPV, at Hansa Biopharma AB

Caroline Susanne Sandström
Info Scientific Board

Caroline Susanne Sandström

Head of Global Clinical Quality at Ferring Pharmaceuticals A/S

Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. Her special interest for chronic inflammation, pharmacology and immunology was reflected in the thesis which was dealing with both human and murine-based systems. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects. Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. She was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture. After almost seven years in Novo Nordisk A/S, Caroline Sandström started as Compliance Specialist at Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she has been involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area. From beginning of May 2022 she moved into the position of being Head of the Global Clinical Quality Department. Her scientifically driven problem solving skills are used for implementing global cross-functional initiatives, supporting and strengthening the harmonization and quality mindset in the organization.

Jeanette Johansson
Info Speaker

Jeanette Johansson

Pharmacovigilance Inspector at the Swedish Medical Products Agency

I am a Swedish pharmacist with strong interests in patient safety and pharmacovigilance. I began my career within Pharmacovigilance in 2006 when I joined the Uppsala Monitoring Centre (UMC), a WHO Collaborating Centre for International Drug Monitoring. At the UMC my main responsibilities included signal management (detection and assessment of risks associated with the use of a medicinal product) as well as education and pharmacovigilance training of staff at national pharmacovigilance centres.
Since 2014, I have held several positions within the pharma industry, mainly in the areas of setting up pharmacovigilance systems, ICSR handling, risk management, pharmacovigilance auditing, signal management and pharmacovigilance training.
In my current role as a Pharmacovigilance Inspector, I plan and conduct national pharmacovigilance inspections, participate in international working groups and carrying out inspections on behalf of EMA.

Juan Paolo Granada
Info Speaker

Juan Paolo Granada

Senior Pharmacovigilance Physician at Ferring Pharmaceuticals A/S

Juan Paolo Granada is a medical graduate from the University of the Philippines and has over 10 years of experience in the field of patient safety and pharmacovigilance. He has worked in companies within the fields of vaccines, consumer products and pharmaceuticals. Aside from his safety physician responsibilities he is currently co-chairing Ferring Global Safety’s Combination Products matrix team and is working on various projects to ensure regulatory compliance and improve processes involving combination products.

Maria Laustsen Murholm
Info Speaker

Maria Laustsen Murholm

Compliance Specialist for Digital Health at Novo Nordisk

Education: BSc and MSc in Molecular Biology, University of Southern Denmark; PhD in Basic Metabolic Research, Faculty of Health and Medical Sciences, Copenhagen University; Pg Diploma in Pharmacovigilance, University of Hertfordshire.

Positions: PV Specialist at Leo Pharma, Senior Safety Surveillance Advisor at Novo Nordisk, GVP and inspector of medical devices in clinical investigation at Danish Medicines Agency

Current position: Compliance Specialist for Digital Health at Novo Nordisk

Peter Nowicki
Info Speaker

Peter Nowicki

Senior Director of Innovation Lab & PV Products at RxLogix

Peter brings over two decades of extensive experience in life sciences, specializing in pharmacovigilance (PV) and clinical trials. With a background as a Medical Doctor and Medical Computer Scientist, he has collaborated with various clients, including top pharmaceutical firms and health authorities.

His primary focus lies in introducing innovative technologies to advance drug safety assessment and monitoring. His expertise centers on developing analytical approaches for automated interpretation of safety signals, contributing significantly to the field.

In his current role as Senior Director of Innovation Lab & PV Products, Peter leads efforts to integrate emerging technologies into pharmacovigilance practices. His dedication to scientific rigor and practical application continues to shape advancements in PV product research.

Maj-Britt Schmidt Andersen
Info Speaker

Maj-Britt Schmidt Andersen

Medical Devices Intelligence and Compliance Manager in Global Safety at Ferring Pharmaceuticals A/S

Maj-Britt Schmidt Andersen holds a MSc in Human Nutrition and a PhD in Nutritional metabolomics from the University of Copenhagen. She moved into the medical device industry in 2020 and has since then been particularly interested in post-market safety surveillance for medical devices and combination products as well as the cross-functional collaboration that is key to obtain efficient and compliant processes. In Ferring Pharmaceuticals, she is working on process improvement projects and regulatory surveillance, and she is co-chair of the Ferring Global Safety’s Combination Products matrix team.

Per Sindahl
Info Speaker

Per Sindahl

Senior Pharmacovigilance Assessor at Danish Medicines Agency

Per Sindahl is a senior assessor at the Danish Medicines Agency. He is a trained pharmacist with a broad and extensive experience in pharmacovigilance, including six years in the pharmaceutical industry. In addition, he holds a BA in Philosophy. In 2018, he started on the professional PhD programme at Utrecht University. Currently, he is working on a research project with the aim of evaluating the effectiveness of risk minimization measures. This project is conducted in close collaboration with clinicians in the field. Per is motivated by bridging science and drug regulation in order to optimise the use of medicines for the benefit of patients and clinicians.

Janie Willadsen
Info Speaker

Janie Willadsen

Associate Director, QA GCP/PV at Genmab

Bio available soon

Sponsors

 

 

Would you like to become a Sponsor?
Please contact us to receive more information about the sponsorship offers
and which benefits they include.

Contacts

Francesca Archetti
Marketing and Sales Specialist
francesca.archetti@lsacademy.com

Roberta Alberti
Events and Training Manager
roberta.alberti@lsacademy.com


Registration Fee

€ 680,00 Early Bird fee until 13 October 2024
€ 790,00 Ordinary fee
€ 490,00 Freelance, Individual, Academy, Public Administration

Fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, networking lunch, coffee breaks, organisational office assistance, certificate of attendance.


Useful Information

The conference will take place at:

HUONE Copenhagen
Amager Strandvej 390 – 2770 Kastrup

Walking from Metro HUONE Denmark

HUONE Kastrup is only a 5-minute walk from Kastrup metro station. Take the exit to the east (towards Øresund) and walk along the road Alleen for approx. 200 metres. HUONE Kastrup is located on the right-hand side, across the car park.

Past Conferences
2023
Different Perspectives and New Challenges within Pharmacovigilance Regulated Activities
2022
Current Challenges and Emerging Trends in Pharmacovigilance: a Focus on the Nordic Countries
2021
Sharing Current Best Practices and Strategic Approaches within Pharmacovigilance Regulated Activities
2020
New perspectives and future needs of Pharmacovigilance in the Nordic Countries: embracing the opportunities ahead
2019
“HOT TOPICS”- INCREASING AWARENESS OF SIGNIFICANT AND ESSENTIAL NEEDS IN PHARMACOVIGILANCE
2018
PHARMACOVIGILANCE CHALLENGES: HOT TOPICS IN 2018
2017
Pharmacovigilance Challenges: Hot Topics in 2017
2016
Pharmacovigilance challenges: hot topics in 2016
2015
Hot Topics in Pharmacovigilance
2014
Nordic Pharmacovigilance Day 2014
Register
Early Bird
Available until 13/10/2024
680,00
Ordinary
Available until 12/11/2024
790,00
Freelance – Individual – Academy – Public Administration
Available until 12/11/2024
490,00
Clear

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Sponsors

<p style="text-align: center;"><strong>HUONE Copenhagen<br />
</strong><span>Amager Strandvej 390 – 2770 Kastrup</span></p>
<p style="text-align: center;">

HUONE Copenhagen
Amager Strandvej 390 – 2770 Kastrup

<p style="text-align: center;"><strong>HUONE Copenhagen<br />
</strong><span>Amager Strandvej 390 – 2770 Kastrup</span></p>
<p style="text-align: center;">