Nordic Pharmacovigilance Day

Graduated from Copenhagen University, the Medical Faculty, in 1986. She became specialist in internal medicine in 1995. Following 12 years employment at university hospitals in the Copenhagen area she joined the Danish Medicines Agency in 1998 and was appointed Chief Medical Officer in 2002. She was member of the Pharmacovigilance Working Party 1998 – 2012 and of the Pharmacovigilance Risk Assessment Committee from July 2012 until February 2019. Her experiences cover all aspects of pharmacovigilance, including the legal framework, scientific and strategic aspects and communication. In 2007 she achieved a master degree in public administration from Copenhagen Business School. In March 2019 she founded the independent consultancy Unique Advice, specialized in pharmacovigilance.

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.

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.

Alex has worked 4 years at Novo Nordisk as a project manager with focus on IT implementations and use of emerging technologies. Prior experience comes from 15 years in IT (mostly IBM), working in PM and management positions.

Senior international pharma leader, visionary and passionate for creating and delivering sustainable solutions to answer patient needs. I achieve results through talent management, building and leading world-class teams in a global setting.
With nearly 25 years-experience in pharma industry with Novo Nordisk, LEO Pharma, Eli Lilly, Santaris Pharma and latest Zealand Pharma in different roles, different functional and therapy areas (diabetes, bleeding disorders, intensive care, cancer and dermatology), I have built competencies in drug and device development and commercialization. My core expertise is within drug safety/pharmacovigilance, medical science and medical communication, regulatory processes (dossier/label negotiations with major regulatory authorities) and clinical quality assurance.

With 10 years of experience within the pharmaceutical industry and another 10+ years in consulting, Martin is an experienced manager and strategist, with understanding across the pharma business value chain, and an expert on Pharmacovigilance. His current role is CEO of Insife, a global consulting and technology company, supporting life sciences companies. In his previous role, he headed the pvtech global industry pharmacovigilance technology network with more than half of top 100 pharma participating. From industry, Martin has seven years of experience at senior management level and has furthermore been engaged as a governance Board member for project investments at a top 10 pharmaceutical company.

Key areas of expertise include:
Strategy development, planning and implementation
Digital transformation and big/real-world data in pharma
Pharmacovigilance, Regulatory and Clinical process optimization
Program and portfolio management
Data integration and business intelligence

Qualifications and Awards
MSc Communication Studies
SIMI / MMPIPrince2, P3O Practioner

Kåre is heading EMA/EU related activities within pharmacovigilance at the Danish Medicines Agency and has since 2015 been focusing on safety surveillance. He has a broad background following 15 years in the pharmaceutical/biotech industry in various leadership positions, ranging from discovery to safety. Prior to the industry, he did a M.Sc. in experimental biology and a Ph.d. and post doc within immunology/medicine. He has supervised M.Sc. and Ph.d. students, participated in several research boards bridging industry and academia and has 40+ peer reviewed co-authorships in international journals.

Line Michan is currently Medicines Inspector with main responsibility for pharmacovigilance inspections and she is part of the EU Pharmacovigilance Inspectors Working Group.
Line Michan has been working with patient safety and pharmacovigilance at the Danish Medicines Agency since 2007, where she has been involved in both national safety surveillance as well as in the EU Pharmacovigilance Risk Assessment committee.
Line Michan holds a Master degree and a PhD in Science from the University of Copenhagen.

Betina Østergaard Eriksen is currently Vice President, Safety Surveillance at Novo Nordisk, where she is responsible for signal management, risk management and aggregate reporting across the product portfolio. She is a registered physician from the University of Copenhagen. Since joining the pharmaceutical industry in 2001, she has been working in different European and global leadership roles across R&D, where she has broad pharmacovigilance experience from almost 15 years in drug safety in different companies.

Inge Zomerdijk is currently working at the pharmacovigilance department of the Medicines Evaluation Board (MEB) in the Netherlands since 2010. She is a senior pharmacovigilance assessor and as a regulator she has experiences in assessing Risk Management Plans, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center in Rotterdam, the Netherlands. Her research was specifically focused on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry. She is still involved in research that the MEB in collaboration with universities is conducting in the field of outcome of risk minimisation measures.