Nordic Pharmacovigilance Day - Relatori

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 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

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.

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 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.

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 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 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 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.