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

Andrew is Vice President & Head of Safety Innovation & Analytics at GSK and leading the development of next generation Safety capability and a member of the Global Safety Leadership team. Previously Andrew was in the Global Epidemiology Leadership team at Pfizer for a decade and prior to that at the WHO Collaborating Centre for International drug Monitoring for more than 12 years, where he led the Research function.

Andrew has contributed to several international initiatives and partnerships including participating in The Council for International Organizations of Medical Sciences (CIOMS) on Working Group VIII on safety signal detection as the WHO nominated representative, and as a member of the US FDA Science Board Subcommittee on Pharmacovigilance (2010 to 2011). Currently, Andrew sits on the Transcelerate BioPharma Pharmacovigilance Steering Committee and Integrated Leadership Team for GSK, was the Executive Sponsor the Intelligent Automation initiative currently co-sponsors of the Modernizing Pharmacovigilance workstream. Andrew is also a member of CIOMS XIV on Artificial Intelligence in Pharmacovigilance.

Andrew has over 100 peer reviewed scientific publications related to pharmacovigilance and AI. Andrew holds a Masters degree in Chemistry from Oxford, and a PhD in Clinical Pharmacology from Umea University, Sweden. He was a Visiting Professor in Information Systems and Computing, at Brunel University, an Adjunct Associate Professor in Clinical Pharmacology at NYU and affiliate faculty of the Center for Health Informatics and Bioinformatics. Andrew is Honorary Professor of Epidemiology at London School of Hygiene and Tropical Medicine.

Linda Bech, M.Sc. is an experienced pharmacovigilance professional with over 14 years in the pharmaceutical industry. She holds a Master of Science in Health Promotion and has developed extensive expertise in patient safety across both local and global settings.

Linda has held senior leadership roles, including Head of Country and Regional Pharmacovigilance at Bristol-Myers Squibb and Gilead Sciences, as well as Director of Global PV Operations at Ascendis Pharma. Her experience spans strategic oversight of pharmacovigilance systems, management of global and affiliate safety operations, and contract and vendor governance.

Currently, Linda leads a team of specialized consultants focused on post-marketing and clinical safety. She is dedicated to delivering tailored pharmacovigilance consulting services that align with the evolving needs of clients and regulatory expectations.

Pernille is a Doctor of Veterinary Medicine with more than  10 years of experience in international pharmacovigilance and drug safety. Pernille is  currently  deputy QPPV at LEO Pharma, where her focus and dedication are driving improvements and simplifications throughout PV systems with a special interest in partner relations, agreements and negotiations of contractual terms and optimizations of outsourcing and vendor collaboration. Further to this Pernille is driving the PV aspect of NIS and IIS processes as well as coordinating and providing PV input to audits and inspections, QPPV review and approval of RMPs and PASS and is responsible for pharmacovigilance agreements.

Previously, Pernille held specialist and leadership roles at the Danish Medicines Agency, contributing to and overseeing PSUR, RMP and PASS evaluations, working closely with the pharmacovigilance risk assessment committee (PRAC).

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.

Bio will be available soon

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.

He began his career at seQure (formerly a branch of Arithmos) in a junior role focused on pharmacovigilance and quality assurance.Over the years, he has gained substantial experience and qualifications in quality assurance, with a particular focus on auditing within GCP (Good Clinical Practice) and GVP (Good  Pharmacovigilance Practice) environments.
Currently, he actively supports clients in the maintenance of Quality Management Systems (QMS) and the audit of third-parties (clinical sites and CROs in GCP area and PV service, business partners and distributors in GVP area).

Since 2019, has held positions of increasing responsibility in the fields of Pharmacovigilance, Quality Assurance, Regulatory Affairs, and Scientific Services. Initially
engaged in consultancy within the Pharmacovigilance department, with operational roles from 2019, and appointed Head of the Pharmacovigilance Unit in 2022. Simultaneously assigned to the Quality department as a certified Auditor and QAPV, contributing to the implementation of corporate quality management systems.
Also assumed the role of EU-QPPV in 2022. In 2024, served in the pharmaceutical industry as Southern Europe Science Manager at UPSA, in a cross-functional role involving Pharmacovigilance, Regulatory Affairs, and Scientific Services. As of January 2025, holds the position of Pharmacovigilance Director at Arithmos, a consultancy company specializing in the pharmaceutical sector.