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

Agenda work in progress

If you want to speak at the conference, please contact Francesca Archetti (francesca.archetti@lsacademy.com) or Roberta Alberti (roberta.alberti@lsacademy.com)

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.

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.

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.

Sponsors

Gold Sponsor

 

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
€ 440,00 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
Printable Version
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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;">