About

 

Different Perspectives and New Challenges within Pharmacovigilance Regulated Activities

2023 is a special year for the yearly conference “Nordic Pharmacovigilance Day”, as it has successfully reached the 10th edition which will be held in Copenhagen on November 16th 2023.

It will be a full day event focused on the current and interesting topics for people working in depth with pharmacovigilance regulated activities or with any interlinking activities in e.g. related departments, in northern Europe.

Knowledgeable experts coming from pharma industry, health authorities, service providers and CROs, will share their experiences and will be available for discussion and questions.

The aim of this conference is to bring the learning opportunity for pharmacovigilance professionals to  discuss, interact, actively participate and get inspired from the speakers as well as from each other.

Considering that the expectation covering pharmacovigilance is quickly evolving within several different areas, the agenda of the conference will offer different perspectives from e.g. regulators, insights from partners and providers, and presenting examples from both small and big pharma companies.

The talks will focus on:

  • Regulatory processes in pharmacovigilance activities
  • Early experiences of the EU CTR n.536/2014
  • Optimization of pharmacovigilance processes
  • Handling of new sources of safety information
  • Globalization of PSMF
  • Learnings from PV audits – internal activities and external vendors
  • Medical Devices: vigilance and signal detection
  • Combination products: challenges and solutions

Would you like to attend? Don’t forget to register in advance to secure your seat at the Early Bird fee. It will be a pleasure to celebrate the 10th anniversary of the Nordic Pharmacovigilance Day together.

 

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
08:30
09:00
Registration
09:00
09:10
Welcome by the Scientific Board
09:10
09:50
Regulatory processes in pharmacovigilance activities, the authority perspective on interfacing departments involved in a PV inspection
Jeanette Johansson - Pharmacovigilance Inspector at the Swedish Medical Products Agency

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.

09:50
10:30
Learnings from Pharmacovigilance Audits
Bilal Ghazal - Senior Manager Pharmacovigilance and GDP Audits, Quality Audits at Novo Nordisk

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.

10:30
11:00
Coffee Break
11:00
11:40
Using one platform across the pharma value chain
Pilar Carrero - Vice president Global Safety at LEO Pharma A/S

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.

11:40
12:20
Harnessing the power of social media to promote medicines safety
Shannen Young - Social Media Coordinator at Uppsala Monitoring Centre

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.

12:20
13:20
Networking Lunch
13:20
14:00
Medical device and combination products: Vigilance and post market surveillance (PMS)
Linda Matti - Associate Director, Deputy QPPV, PV operations at Ascendis Pharma

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.

 

14:00
14:40
Early experience of the EU CTR
Søren Nilaus Præstegaard - PV Compliance Specialist at Novo Nordisk

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

14:40
15:10
Coffee Break
15:10
15:50
Optimization of case processing through AI and data science
Michael Braun-Boghos - Senior Director Safety Strategy at Oracle Health Applications & Infrastructure

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.

15:50
16:30
Globalization of PSMF
Klaus Bitsch-Jensen - Director, Head QPPV Office & EU-QPPV - Global Pharmacovigilance & Clinical Development at Alk
Gitte Eiersholt - PV Specialist, PV Europe at Alk

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?

16:30
16:40
Conclusions
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.

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.

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

Klaus Bitsch-Jensen
Info Speaker

Klaus Bitsch-Jensen

Director, Head QPPV Office & EU-QPPV - Global Pharmacovigilance & Clinical Development at Alk

Klaus Bitsch-Jensen has a master degree in pharmaceutical science from the Danish Pharmaceutical University, Copenhagen, and a graduate diploma in business administration from Copenhagen Business School.
He has worked within the pharmaceutical industry since 2007 primarily within pharmacovigilance, within different pharmaceuticals companies, and in various roles within safety operations, safety surveillance, and QPPV Office settings.
He is currently working at ALK as Director, Head of QPPV Office & EU/UK-QPPV heading up a team of pharmacovigilance specialists responsible for the maintenance of the EU-PSMF & national PSMF management, regulatory surveillance, performance monitoring, PV training, PV Agreements, and general support to affiliates and partners.

Michael Braun-Boghos
Info Speaker

Michael Braun-Boghos

Senior Director Safety Strategy at Oracle Health Applications & Infrastructure

Michael has been working in medicinal product safety for the last three decades. He spent 13 years at the European PV headquarters of Fujisawa, which later became Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle with the Relsys acquisition in 2009. As a senior director in the safety strategy team, he helps drive the product roadmap of the Oracle Safety One Platform including Argus, Empirica, Safety One Intake, and Oracle Analytics.

 

Pilar Carrero
Info Speaker

Pilar Carrero

Vice president Global Safety at LEO Pharma A/S

Pilar Carrero is a Medical Doctor with a PhD in Biochemistry & Molecular Biology with 20+ years of experience in the pharmaceutical industry. She has dedicated 15 years to research in both academia (Karolinska Institute in Stockholm) and industry (Novo Nordisk in Copenhagen) working in metabolic diseases and oncology, and 18 years in different roles in pharmacovigilance where she has been a frontrunner in the implementation of optimization activities in processes and systems. Pilar is heading up Global Safety at LEO Pharma since October 2021 where the area has embarked in the implementation of a new safety platform. Pilar is passionate about new technologies and their application to transform the way we work.

 

Gitte Eiersholt
Info Speaker

Gitte Eiersholt

PV Specialist, PV Europe at Alk

Gitte Eiersholt is a pharmaconomist, trained at a Danish pharmacy and has worked within the pharmaceutical industry after the education. In addition, Gitte holds a master degree in data linguistics and training certificates in coaching, managing diversity, and successful cooperation.
She has worked with PSMF management since 2013, first with Novo Nordisk and since 2020 with ALK.
She is currently working at ALK as a senior PV specialist focusing on how to manage local PSMF requirements in the most efficient and standardized way to the benefit of the MAH and the partner facing the requirement.

Bilal Ghazal
Info Speaker

Bilal Ghazal

Senior Manager Pharmacovigilance and GDP Audits, Quality Audits at Novo Nordisk

Masters’ in Pharmacy at Copenhagen University. Currently working as Senior Manager in Quality Audits, Novo Nordisk A/S heading up the department “Pharmacovigilance and GDP Audits”. He is responsible for the operational management of team of auditors responsible for GDP/PV oversight within the organization.

Has more than 25 years of auditing and quality experience in pharmaceutical industry which includes auditing in all GxP areas globally, in depth knowledge pharmaceutical processes/ analyses, quality tools and philosophies. Has acquired understanding on Validation, IT and digital innovation and its impact on Pharmacovigilance system within the organization and HA requirements. Involved in implementing successful internal audit programs that have contributed to the company’s growth and success. Is responsible for managing and leading the PV and GDP auditors which contributed to enhancing the company’s internal controls, risk management, and compliance frameworks.

Has been an active mentor to several internal audit professionals within Novo Nordisk, and has provided them with valuable guidance, support, and professional development opportunities.

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.

Linda Matti
Info Speaker

Linda Matti

Associate Director, Deputy QPPV, PV operations at Ascendis Pharma

Associate Director, Deputy QPPV, PV Operations (MSc.Pharm., certified internal auditor ISO 13485, certified process consultant) with more than 13 years of experience in different roles working with medicinal products, medical devices and combination products across all stages from early development throughout products’ lifecycle.

Currently and for the last six years, course responsible/instructor for the annual 1.5 days course on planning an effective post-market surveillance (PMS) program for medical devices and combination products at Medicoindustrien.

Currently and for the last six years, chairwoman for the Medtech industry’s large PMS group at Medicoindustrien.

Søren Nilaus Præstegaard
Info Speaker

Søren Nilaus Præstegaard

PV Compliance Specialist at Novo Nordisk

Søren Nilaus Præstegaard is a pharmacist by training and has been working in the pharmaceutical industry since 2004. Since 2007, Søren has been working within the pharmacovigilance area in companies such as Ferring Pharmaceuticals, NeuroSearch, LEO Pharma A/S and Novo Nordisk A/S. Through his career, Søren has been working within many different areas within Pharmacovigilance in both specialist and management positions and has obtained broad knowledge of the different aspects of Pharmacovigilance. In Søren’s current role as a PV Compliance Specialist in Novo Nordisk, he is responsible for Pharmacovigilance intelligence.

Shannen Young
Info Speaker

Shannen Young

Social Media Coordinator at Uppsala Monitoring Centre

Shannen is a communicator by trade and a creative at heart. She enjoys crafting compelling social media campaigns using several mediums, whether that be graphic design, film, data visualisations, copywriting or more. She is passionate about telling unique stories and turning complex ideas or methodologies into digestible and engaging content. Before joining Uppsala Monitoring Centre (UMC) in 2022, she worked with various communications tasks at the Stockholm International Peace Research Institute (SIPRI). She holds a BA from Simon Fraser University (Canada) and an MA from Uppsala University (Sweden).

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Contacts

Francesca Archetti
Events and Training Manager
francesca.archetti@lsacademy.com

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


Registration Fee

€ 680,00 Early Bird fee until 16 October 2023
€ 790,00 Ordinary fee
€ 440,00 Freelance, 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:

Park Inn by Radisson Copenhagen Airport
Engvej 171 – 2300 Copenhagen

Park Inn by Radisson Copenhagen Airport is situated near both the Copenhagen Airport and the city centre. If you arrive by car, this hotel’s location in Copenhagen, Denmark provides free parking. The nearby metro and train stations are convenient for cyclists and guests without cars.

Transport options
Metro station Femøren (two stops to airport and six to city centre) – beside hotel
Copenhagen International Airport – 3 km (5 min by metro)
Copenhagen Central Station – 7 km (10 – 15 min by car)

Past Conferences
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
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<p><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171 – 2300 Copenhagen &#8211; Denmark</p>
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Park Inn by Radisson Copenhagen Airport
Engvej 171 – 2300 Copenhagen – Denmark

 

<p><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171 – 2300 Copenhagen &#8211; Denmark</p>
<p>&nbsp;</p>
<p><strong>Park Inn by Radisson Copenhagen Airport<br />
</strong>Engvej 171 – 2300 Copenhagen &#8211; Denmark</p>
<p>&nbsp;</p>