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.

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 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

Mads Nielsen has a BSc, in Physics and Computer Science, an MSc and a PhD in Computer Science, University of Copenhagen (UCPH) from respectively 1989, 1992, and 1995. He was guest researcher at INRIA Sophia-Antipolis 1993/94, post doc at Imaging Sciences Institute Utrecht, 3D-Lab, Faculty of Medicine, UCPH, associate professor and professor at IT-University of Copenhagen, and Head of Department and Professor at DIKU, Department of Computer Science, UCPH, where he is member of the Pioneer Centre of AI and PI on a number of grants related to computing in biomedicine.

In 2012 he published what we believe is the first work on using deep learning in medical image analysis together with Andrew Ng, Stanford; and have since contributed to fundamental and applied work in this direction. He has been invited to host workshops on this topic at SPIE, IEEE ISBI, and more. Towards medical application, he has contributed to among other applications in musculoskeletal diseases, cardiovascular diseases, lung diseases, breast cancer, infectious diseases including Covid-19, and dementias. He has published more than 300 peer reviewed papers.

He has founded a number of companies in this area including Prenaital, Biomediq, AIomic, Cerebriu.

Revathi is a pharmacologist with an MD in Clinical Pharmacology and over 10 years of experience in pharmacovigilance. She specializes in regulatory compliance, pharmacovigilance inspections and safety signal management within the pharmaceutical industry.

Alicia holds a PhD in Immunology and has over 10 years of experience in pharmacovigilance. She specializes in safety surveillance analytics and signal detection methodologies within the pharmaceutical industry.