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
Speakers
Wasim Anwar
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
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
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.
Henrik Bengtsson
Patricia Jiménez Vasquez
Dr. Patricia Jiménez Vasquez is a biochemist with a Ph.D. in Neuroscience from the renowned Karolinska Institute, bringing over 30 years of expertise in the pharmaceutical industry. For the past two decades, she has been a key player in the field of Pharmacovigilance/Drug Safety, serving in pivotal roles in global, Nordic, and Swedish pharmaceutical companies such as AstraZeneca, Merck Sharp & Dohme, Otsuka, Vivesto, as well as in a Contract Research Organization, where she honed her skills in pharmacovigilance and gained valuable insights into the specific requirements for recruiting specialists in this critical area.
Her extensive experience encompasses the entire spectrum of pre- and post-marketing pharmacovigilance, with a keen focus on global drug safety efforts as well the needs in a pharmacovigilance division in marketing companies. Patricia’s work has spanned diverse organizational landscapes, from small to large pharmaceutical entities, underscoring her versatility and profound understanding of industry dynamics.
A driving force behind ensuring the effectiveness and safety of drugs on the market, Patricia’s unwavering commitment aligns with her personal goal: to contribute to the development of safe and impactful pharmaceuticals, while advocating for equitable access to medicine for all.
With a wealth of experience bridging industry and academia, Patricia uniquely amalgamates scientific acumen, regulatory insight, and an impassioned dedication to advancing healthcare solutions. Her expertise extends to the pre-qualification process and expectations for Pharmacovigilance suppliers, and she is dedicated to leveraging her knowledge to make a tangible impact in the pharmaceutical landscape.
Jeanette Johansson
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
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
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
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
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
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
Would you like to become a Sponsor?
Please contact us to receive more information about the sponsorship offers
and which benefits they include.
Media Partner
In collaboration with Nordic Life Science, all the participants will receive a digital copy of their latest issue free of charge at the end of the conference.
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 14 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:
Hotel Scandic CPH Strandpark
Amager Strandvej 401 – 2770 Kastrup
The hotel is located next to Oresund with fantastic views of the water, bridge and city skyline. The area offers a wide selection of recreational outdoor activities, and you can reach downtown Copenhagen in 12 minutes. Copenhagen airport is only 1 metro stop (Kastrup Station) away.
Past Conferences
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