Team

Mats Ehrnebo is senior consultant within drug development and pharmacokinetics since many years. Mats is the author and co-author of about 50 scientific publications, and is Associate Professor at the Faculty of Pharmacy, University of Uppsala. He has during several years been a board member and secretary of the Swedish Society for Clinical Studies (Swedish Pharmaceutical Society). Mats has worked for Karolinska Pharmacy, Galenus, and Innovex and is the founder and former owner of Pharm Assist.

Sari Öbrink is a pharmacist and she is assigned within Pharmacovigilance and as Responsible Person for Wholesale. She is experienced from different areas in the pharmaceutical industry and competent authorities. Among other thing she has been a pharmacokineticist at the pharma company Orexo and she´s been working with pharmacovigilance at the Medical Product Agency.

Jennie Andersson has a PhD in pharmaceutical sciences and serves as a medical device, quality assurance and regulatory affairs consultant. She has years of experience on interim management positions in young medical device companies and has built and implemented quality management systems in many of them. She is used to collaborating with development teams regarding compliance and CE labeling. Jennie specialty is diagnostic products (IVD), medical device software (SaMD) and innovative eHealth products.

Elisabeth Widmark is a pharmacist and her main focus is as a Regulatory Affairs Consultant, both within international and local Regulatory Affairs, and as a GDP consultant, where she is acting as Responsible Person for Wholesale for both small national and large global companies. She also provides training in Pharmacovigilance and GDP. She has a broad experience within Regulatory Affairs, after more than 10 years at Fresenius Kabi. She has also experience from Quality Assurance and acting as Local Safety Officer in the Nordic countries.

Anna Janises has a MSc in Biomedicine from Uppsala University. At Pharm Assist she works as QA Manager and as a GDP-consultant, primarily with national distributors and transport companies. Anna has worked with quality assurance in Life Science companies since 2014.

Malin Larsson is a pharmacist and she has been in our team since 2008. She is working with Regulatory Affairs and coordinates our Fass assignments. Malin is IMA certified and reviews marketing material for medicinal products.

Malin Östrand is a pharmacist and joined our team in 2019. She has +10 years professional experience in Regulatory Affairs from pharma companies and the Swedish Medical Products Agency. She also has experience of Pharmacovigilance and Quality (GDP). Malin is certified to review promotional materials for Sweden (IMA certificate).

Anna-Maria Aulin is a pharmacist and her main focus is Pharmacovigilance, GDP and Regulatory Affairs. She has more than 10 years of experience from working as consultant within Regulatory Affairs with both local and global projects. Anna-Maria is also experienced in Pharmacovigilance as well as complaint management for products marketed in the Nordic markets.

Agata Wasik is a Medical Writer at Pharm Assist. She has a Ph D in immunopharmacology and has ten years of experience as a haematology scientist at Karolinska Institute (Stockholm), with many multi-disciplinary and industry collaborations. Agata has substantial experience as an author and as a reviewer of research articles for scientific journals.

Annika Söderpalm is one of Pharm Assist’s medical writers. She has a PhD in biology and a degree in journalism. Annika’s doctoral work concerned development and degeneration of retinal sensory cells. She has also done research on the neuropharmacology of addictive substances. Annika has since worked for many years as a medical writer, medical copywriter and science communicator within the pharmaceutical and life science industries.

Eva Ristoff is a medical writer at Pharm Assist since 2021. She has a Master and a PhD in Medical Sciences and her doctoral work concerned thrombosis and inflammation in coronary artery disease. Eva has 20 years’ experience from the pharmaceutical industry in areas of medical writing, medical information, pharmacovigilance, clinical research / study management, medical and regulatory affairs and QA/GDP. She has worked within rheumatology, dermatology, inflammatory bowel disease and Parkinson’s disease.

Quality Assurance och Regulatory Affairs Medical Devices Gunnar Magnusson holds a Master of Science in Chemical Engineering and a TeknLic i Biotechnology from the Royal Institute of Technology. He has more than 20 years of experience from the biotech industry, mainly in the field of in vitro diagnostics. Gunnar has a broad experience base from product development, sales, quality assurance and regulatory affairs. For example, he has developed quality management systems, technical documentation and managed internal audits. At Pharm Assist Gunnar is a consultant in quality assurance and regulatory affairs in the field of in vitro diagnostics and medical devices.

David is a Quality Assurance and Regulatory Affairs consultant. He has over two decades of experience from pharma-, medical device- and biotechnology industry. Having assumed different roles over the years has led to hands on involvement in building and implementing quality management systems (QMS), strategic planning in CE-marking, and work as both Qualified Person and PRRC. David has particular expertise in sterile products, infusion therapy and audits of supply chains and QMS processes.

Karin Lundkvist is a consultant in the fields of pharmacovigilance and regulatory affairs. She has more than 20 years of working experience from the Swedish Medical Product Agency. In recent years Karin has been highly involved in assessments of adverse events reports, MedDRA-coding, quality reviews and pharmacovigilance training. Also, she has many years of experience in regulatory procedures and product information reviews for human and veterinary medicinal products.

Johan Wetterberg is a pharmacist and has more than twenty years of experience from leading positions in the pharmaceutical industry. Johan has worked with clinical trials (GCP), quality control in pharmaceutical drug production (GMP) and in recent years with wholesale of pharmaceutical drugs. Johan's area of expertise is mainly Good Distribution Practice.

Olivia Schink is a pharmacist and consultant within Regulatory Affairs. She has previously worked with local regulatory affairs activities in the Nordic and Baltic countries. Olivia also has several years of experience with clinical trials in the Nordic and Baltics, including study start-up activities, creation of informed consent forms, initial applications and amendments to Ethics Committees as well as biobank applications in Sweden. Olivia is IMA certified and reviews marketing material for Sweden.