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.

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.

Bio available soon

Bio available soom

Pharmacist by training.
Has been with Lundbeck for 3 years; 1 year in Medical Information, and 2 years in Global Patient Safety.
Former Local PV experience from MI/PV role in an affiliate.
Current role in the function “Local Patient Safety Support”, supporting and managing oversight of Local Patient Safety in affiliates and at vendors.

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

Ea Marie Holst is a Partner at Pharma IT, a pharma-focused consultancy that assists its clients across all key areas within the pharmaceutical, biotech, and medical device industries.  As a seasoned pharmacovigilance professional with 15 years of experience in the pharmaceutical and medical device industries, she leads the firm’s pharmacovigilance team. Ea has worked in both headquarters and affiliates with all aspects of post-marketing pharmacovigilance and clinical study safety including; Risk management, external and internal Data Monitoring Committees, Signal detection, benefit-risk evaluation, building and maintaining quality management systems, Pharmacovigilance training, E2b reporting and testing, literature monitoring, ICSR case processing and reporting, reconciliation and coding in clinical trials, complaint and medical information handling and reconciliation. She is GCP certified, as well as trained in Argus Safety and ARISg™. 

Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012 and is currently working in the role of Expert GPvP Inspector.  She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP), has had a role in the training of GPvP Inspectors in other worldwide regulatory agencies and has contributed significantly to the MHRA’s preparedness work in advance of the UK’s withdrawal from the EU.

Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials.

Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.