Nordic Pharmacovigilance Day - Relatori

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.

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

Karin Erneholm is pharmacovigilance officer at the Danish Medicines Agency where she is working primarily with EU procedures; signal management, signal detection and PSUR assessments. Karin holds a master degree in Veterinary medicine, a PhD in in vivo pharmacology/immunopathology, and worked at a pre-clinical contract research organization prior to joining the Danish Medicines Agency in 2019.

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

Jannik Høvring Nielsen is working in Global Safety as a Safety Surveillance Specialist at the Novo Nordisk headquarters in Denmark.

He has 14 years of experience within pharmacovigilance, 9 of these with Novo Nordisk. During his time in Safety Surveillance Jannik has gained extensive experience in surveillance of marketed products as well as clinical trials, including submission of a new product application to authorities worldwide, including FDA and EMA.

Jannik is currently working with the signal management process at Novo Nordisk, implementation of methodology and strategy for Digital Health data as well as a project to implement new IT tools for signal management and aggregated reports.

Prior to joining Novo Nordisk, Jannik worked 5 years for a large pharmaceutical company where he worked with all areas of pharmacovigilance.

Jannik has a master’s degree in pharmacy from University of Copenhagen, Faculty of Pharmaceutical Sciences from 2007, and a post-graduate diploma degree in pharmacovigilance from University of Hertfordshire in UK from 2012.

Gro Laier, MD graduated from University of Copenhagen in 1987 and have been working within Pharmacovigilance for more than 25 years. She has been working with every aspect of drug safety and pharmacovigilance; but has been focusing on regulatory surveillance, case handling processes and latest data privacy in Pharmacovigilance.

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

Jen has 25+ years of industry, consulting, and software development experience in the Pharmaceutical & Financial industries. The last 23 years of her career have been focused on Drug Safety & Pharmacovigilance and she has worked with many of the top pharmaceutical companies in the world, including Johnson & Johnson and Pfizer. She also spent many years working as a management consultant where she focused on helping a wide range of clients establish, improve, and streamline their safety processes and technology solutions. In her current role as Chief Sales & Marketing Officer at Insife she will strive to continue to bring the best technology and consulting services to the life sciences industry.

Key areas of expertise include:
Drug Safety & Pharmacovigilance technology solutions
Business process improvement and redesign
Pharmacovigilance regulation

Qualifications and Awards
BSc in Computer Science from Dublin City University

ANNA-SHARI MELIN is a leader of the German life sciences practice in Munich. Her practice combines EU and German regulatory, compliance, environmental, social and governance (ESG) as well as private equity/M&A experience. Her clients include pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer goods companies.
Anna has vast experience in product lifecycle multijurisdictional regulatory matters. Her clients value her analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs, pharmacovigilance, supply chain management including shortages prevention, product recalls, marketing and advertising, interactions with healthcare professionals and related compliance, as well as due diligence for life sciences transactions. Anna has advised several international clients, including U.S. food supplement clients, on strategic market entry in Germany and the EU.
Anna has represented clients in matters before the European Commission, the European Medicines Agency, the European Court of Justice and the German Federal Court of Justice (Bundesgerichtshof), for example in pay-for-delay appeals.
She has also been semi-seconded to numerous international pharmaceutical and biotech companies, becoming a right hand to senior in-house lawyers in all their interactions with internal clients, contract partners and Member State regulatory authorities, including those in Germany and the Netherlands. Anna has trained in-house lawyers in relation to the preparation of pharmacovigilance agreements (PVAs), the roll-out of compassionate use programs in a multitude of jurisdictions and compliance with the new EU ESG framework such as the German Lieferkettensorgfaltspflichtengesetz and the proposed Green Claims Directive.
Anna co-leads Sidley’s benchmarking group for in-house pharmacovigilance lawyers (pvlegal) and regularly speaks on timely pharmacovigilance topics. She also co-leads Sidley’s Life Sciences ESG Roundtable, a discussion forum for in-house counsel to exchange in relation to the EU’s evolving sustainability/ESG legislative framework.