Nordic Pharmacovigilance Day - Speakers

Wasim Anwar is a trained physician and a global pharmacovigilance & clinical safety expert with 17+ years of experience across multiple mid-sized & large biopharmaceutical organisations. He has held enterprise leadership roles and involved in shaping global safety science strategy & benefit–risk governance across product lifecycle including early development, late-stage clinical programs, regulatory submissions and post-marketing phases. He holds extensive experience in governing complex benefit–risk frameworks, building effective & efficient PV systems, maintaining compliance oversight, leading international health authorities inspections and translating safety science into executive decision-making insights that support regulatory strategy and lifecycle management.

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. She is now covering the role of Director Clinical Quality Evaluation & Inspection Intelligence at Alvotech.

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 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.

Biography available soon

Jørgen Matz, MSc, PhD, PgD is the Head of Global Pharmacovigilance & Drug Safety for InsudPharma in Madrid, which is a healthcare company with business units for worldwide manufacturing, development, and marketing of branded, generic and biotechnological products. Jorgen Matz has been in the pharmaceutical industry for about 25 years, hereof 15 years in Global Pharmacovigilance & Drug Safety. He has a background as an experimental pharmacologist and his focus areas in recent year has been on implementing pharmacovigilance systems tailored to support ICSR processing and continuous benefit-risk assessments of marketed products.

My background is in science, I am a molecular biologist with a PhD in medical sciences (neurobiology, cell death following stroke) from Lund University. After my post doc at the Danish Cancer Society I started in regulatory affairs, first at LEO Pharma, then working at EQL Pharma and Nordic Drugs. I joined Ferring in 2023 and have the LSO role at the Swedish affiliate.

Dr. Maurizio Sessa is an Associate Professor at the University of Copenhagen. He holds a PhD in Translational Medicine and a Master’s degree in Pharmacy. His research focuses on the development and implementation of new technologies to optimize processes and procedures in pharmacovigilance and pharmacoepidemiology.

Søren Troels Christensen joined the Danish Medicines Agency as a GVP inspector in 2000. He holds experience from + 50 inspections, the majority acting as lead inspector.

Positions of trust include delegate for Denmark in European Medicines Agency Inspectors Working Group, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) – steering committee for GVP, member of the Best Practice working group, deputy for the Joint Visit Program.

Before joining the Danish Medicines Agency, he worked at the Institute for rational Pharmacotherapy, Danish Health Authorities with clinical guidelines on the use of psychotropic medicines, drafting consultation responses to requests from the Ministry of Health, and being responsible for the institute´s post-graduate course portfolio on rational use of medicines. Additional experience includes working with Non-Governmental Organisations in a number of African countries along with a university career including lecturing and supervision of master students.

He has an education background as MSc. Pharm., MSc. African Studies, Ph.D.