Marie Gårdmark CEO and Senior consultant
M Sci Pharm, Ph D
marie.gardmark@regsmart.se
+46 (0)765 – 27 62 65
Marie has a wide range of experience from drug development. She has more than 10 years’ experience as a regulator at the Medical Product Agency in Sweden (MPA), a major contributor to EU regulatory decision making. As Director of Licensing at MPA she was responsible for activities and decisions related to drug approvals and life cycle management including clinical trials and scientific advice. She led the agency’s work with innovation support. Her responsibility covered products of both biological and chemical origin within human and veterinary medicine. As a regulator she has actively contributed to development of new guidelines and legislation.
Dr Gårdmark has 10 years of experience from senior roles in small and big pharma companies mainly in Regulatory R&D as exemplified by development and implementation of global regulatory strategies, due diligence activities and scientific advice meetings in EU and US. Her main focus has been in clinical and preclinical research.
Her scientific background is in clinical pharmacology and pharmacometrics and she has several years of experience from early drug development. She holds a PhD in pharmacokinetics from Uppsala University, Sweden.
Marie Gårdmark is co-founder of RegSmart Life Science AB.
Agneta Larhed Senior consultant
M Sci Pharm, Ph D
agneta.larhed@regsmart.se
+46 (0)727- 46 73 50
Agneta has been active as a researcher and manager within both academic and industrial pharmaceutical innovation and product development for more than 10 years. Her work focused on drug absorption, drug delivery and formulation development, covering a range of formulations and dosage forms such as tablets, gels and microparticles.
In addition, she has been involved in the development of courses and symposia and is currently a board member of the scientific section Pharmaceutics in the Swedish Academy of Pharmaceutical Sciences.
She obtained her PhD at the department of Pharmaceutics at Uppsala University, Sweden.
Agneta Larhed is co-founder of RegSmart Life Science AB.
Ira Palminger Hallén Senior consultant
M Sci Pharm, PhD
ira.hallen@regsmart.se
+46 (0)722-11 29 30
Ira has over ten years’ experience as a regulatory expert covering nonclinical and clinical drug development. She has been a nonclinical assessor at the Swedish Medical Product Agency (MPA) reviewing toxicological/pharmacological documentation in drug applications from early development to market approval.
Furthermore, Ira was Clinical Assessor at the Norwegian Medical Agency (NoMA) reviewing clinical trial applications in all therapeutic areas, with primary focus on oncology. With her regulatory background, Ira has vast experience from giving scientific advice at the national level in Sweden and Norway and she was working at the EMA-level as coordinator and assessor of central scientific advices. The last three years Ira has been working as senior regulatory consultant, supporting clients with regulatory scientific reviews as well as preparation of various documentation for Agency interactions. She covers products of both biological and chemical origin within human medicine. Ira has in-depth knowledge of EMAs regulatory procedures, and the applicability of regulatory guidelines and legislations.
In addition, Ira has twelve years of experience from R&D at AstraZeneca, initially as a Toxicologist working with drug distribution. Subsequently as Sr Clinical Pharmacology Scientist accountable for the clinical pharmacology program in Neuroscience projects including contributions to clinical development plans, study designs and CTA documentations.
Ira holds a PhD in Toxicology from Uppsala University in the area of reproductive toxicology.
Robert Hägerkvist Senior consultant
M Sci Pharm, Ph D
robert.hagerkvist@regsmart.se
+46 (0)730 – 77 46 92
Robert is a pharmacist with a PhD in medical cell biology.
Most recently, Robert comes from the Swedish Medical Products Agency, where he spent eight years as a clinical assessor. As a clinical assessor he has reviewed a number of market authorisation applications as well as providing scientific advice to companies. He has extensive knowledge in regulatory pathways in the pre- and post-marketing setting. Previous to his position as a clinical assessor, Robert spent five years at the Swedish Poisons Information Centre learning clinical toxicology and the importance of efficient communication. Over the years, Robert has been involved in various projects broadly related to medicinal products, ranging from new psychoactive substances to various borderline products.
With a firm background as a regulator Robert strives to find solutions, that are fit for purpose and makes scientific sense.
Katarina Andersson Senior consultant
B Sc in Pharmacy
katarina.andersson@regsmart.se
+46 (0)730 – 41 68 05
Katarina has a long-standing experience as a pharmaceutical inspector, pharmacovigilance (GVP).
Most recently, Katarina comes from the Swedish Medical Products Agency (MPA), where she spent twelve years as an inspector, whereof the last six years as Head of the GVP/GCP group of inspectors. She has extensive knowledge in pharmacovigilance and has been a delegate in the Pharmacovigilance Inspector Working Group at the European Medicines Agency for several years.
The work as inspector has included inspection of national sites as well as European sites and in countries outside EU, e.g., India and USA. The Marketing Authorisation Holders (MAH’s) inspected have ranged from small MAH’s to multinational companies.
In addition, she has 13 years of experience from the pharmaceutical industry in clinical trials and pharmacovigilance.
With long experience in the area of GVP Katarina can provide valuable insight in achieving efficient and well-functioning pharmacovigilance systems in accordance with the regulations.
Sophie Bertilsson Senior consultant
PhD
sophie.bertilsson@regsmart.se
+46 (0)733 – 91 66 30
Sophie has broad experience of the pharmaceutical aspects of drug development. She has over 15 years of experience as project manager as well as expert in the pharmaceutical industry, where her main focus areas have been development and GMP manufacturing of active pharmaceutical substances, drug product supply to clinical trials, and regulatory CMC aspects. The regulatory expert role included development and implementation of global regulatory CMC strategies for projects up until market approval, authorizing regulatory documentation, interactions with health authorities as well as activities related to in- and out- licensing.
Most recently, Sophie comes from the Swedish Medical Products Agency, where she spent four years as a chemistry and pharmaceutical assessor. Her responsibilities included provision of scientific advice, review of clinical trial applications as well as market authorization applications and variations.
Sophie has experience of a wide variety of drug formulations and has also assessed new chemical entities.
She has a special interest in impurities and new manufacturing methods.
Anders Juréus Senior consultant
Ph D, Neurochemistry and Neurotoxicology
anders.jureus@regsmart.se
+46 (0)730 – 79 83 28
Anders has extensive experience from drug development acquired from the pharmaceutical industry, academia and regulatory authorities.
Most recently, Anders worked at the Swedish Medical Products Agency where he was a clinical assessor and manager at the unit of Efficacy and Safety 1. Anders was involved in assessing clinical data and benefit/risk from all stages of the drug life cycle, from scientific advice at earlier stages of development, through the approval process, to evaluation of post-authorization activities and variations.
From the pharmaceutical industry, Anders has more than 10 years of experience of preclinical and translational drug development from positions such as lead biologist and team leader.
Anders has a PhD in neurochemistry and neurotoxicology from Stockholm University and post-doctoral training at the University of Washington in Seattle. In addition, Anders has several years of experience as project manager in clinical psychiatry at the department of Medical Epidemiology and Biostatistics at Karolinska Institutet.
Anders has a solid scientific and regulatory background in drug development with a special interest in neurology, pain and psychiatry.
Eva Ragnarsson Senior consultant
PhD, Pharmaceutics
eva.ragnarsson@regsmart.se
+46 (0) 730 – 67 57 37
Eva is a pharmacist, with vast experience from a wide variety of drug product formulations intended for different administration sites, e.g. oral, parenteral and dermal routes.
Most recently, Eva comes from the Swedish Medical Products Agency, where she spent 15 years as a chemistry and pharmaceutical assessor evaluating the quality of drug substances and drug products prior to authorization. Her responsibilities included provision of scientific advice, review of clinical trial applications as well as market authorization applications and variations.
Further experiences cover early pre-formulation work, cell-culturing techniques, imaging techniques and teaching.
Eva has a special interest in age-appropriate formulations for children and formulations for animals.
Torbjörn Wärnheim Senior consultant
PhD, is Assoc. Prof. in Physical Chemistry
torbjorn.warnheim@regsmart.se
Torbjörn has worked within the life science industry for more than 30 years. With a background in formulation development, he has been responsible for pharmaceutical development and R&D in both smaller and larger life science companies. As senior executive in e.g. Moberg Pharma, Fresenius Kabi and Olink Proteomics he has also been closely involved in management decisions related to strategic aspects of product development and positioning. That includes many practical experiences of development challenges in the different steps of taking a product idea from the early stages to the market.
He has throughout his career worked actively with the CMC regulatory development, such as writing expert reports, regulatory documentation in general, as well as participation in authority meetings, including the FDA. He enjoys analysizing and understanding the scientific and technical issues within the development chain, and then finding appropriate and pragmatic solutions to the upcoming challenges.
Torbjörn looks forward to support customers in pharmaceutical product development, making sure that the regulatory aspects are included to move ahead with the projects.
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Mats Högberg Director medical device & IVDR, Senior consultant
MSc, MBA
mats.hogberg@regsmart.se
+46 (0) 705 – 46 50 21
Mats is a senior executive with global experience in the medical technology and life sciences market. Over the past 25+ years, Mats has worked in several international corporations and started two life science companies.
Most recently, Mats worked as CEO for Pharmacolog AB (publ), listed on Nasdaq First North. Pharmacolog is a MedTech company, specialized in providing tools and solutions for medication efficacy in personalized medicine.
He started his career at Scanditronix AB where he held various sales and marketing positions. After several management roles in other corporations, he became Managing Director for Nucletron Scandinavia AB. At Nucletron, he took various commercial and general management roles in the company, including a role as Marketing Director EMEA at Nucletron B.V. Prior to his assignment in Pharmacolog he held a Vice President position at Elekta AB (publ).
His scientific background is medical engineer and he has a M.Sc. in industrial Marketing and commercial law from Uppsala University, where he also went through an Executive MBA.
Mats have throughout his career strived to find the most appropriate and efficient way to maneuver through the regulatory landscape. Defining the right intended use, choosing the right regulatory strategy as well as a pragmatic implementation of a quality system is key to a cost-effective certification and to shorten time to market.
Sara Gallinetti Senior consultant
PhD in Biomedical Engineering
sara.gallinetti@regsmart.se
+46 (0)730 – 62 66 04
Sara is an expert in clinical documentation under the new medical device regulation (MDR) and in biomedical materials.
Before joining RegSmart, Sara has been working as a senior scientist in academic and industry positions for more than 7 years. She has been working under ISO 13485 and her main focus has been the transition from MDD to MDR compliance of clinical documentation, including clinical evaluation, post market surveillance, post market clinical follow-up (PMCF), periodic safety update report (PSUR) as well as summary of safety and clinical performance of both custom-made and certified products.
Beside her experience with clinical documentation, Sara has been developing and characterizing material formulations, managing in vitro and pre-clinical studies as well as being the external reviewer for R&D documentation. Furthermore, Sara has experience with audits, both internal and external and with release of goods for European and American markets.
With the passion of a researcher, Sara wants to help medical device companies with compliance of their technical documentation and optimization of their product development.
Karin Westermark Senior consultant
PhD, Physics
karin.westermark@regsmart.se
+46 (0)733 – 97 10 26
Karin is a medical device and MDR expert, with vast experience from medical device within both authorities and the medtech industry.
Most recently, Karin worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for six years, the last three as Senior Assessor, responsible for in-depth investigations of market surveillance cases. She was active in implementing the new Medical Device Regulation (MDR) as well as the In Vitro Diagnostic Regulation (IVDR) from the authority perspective. Karin also served as Sweden’s representative in the EU Commission’s group for the Unique Device Identifier (UDI).
Prior to working at the Swedish Medical Products Agency, Karin held various leading technical, medical and marketing positions within product management, development and manufacturing in small and mid-sized companies including medtech and pharma for 13 years.
She also has experience from the role as investigator at the Swedish Radiation Safety Authority for five years, responsible for information, regulation and supervisory guidance for ultraviolet radiation and cosmetic lasers.
Her scientific background is in the field of physics, biology and chemistry. She holds a PhD in surface physics and electrochemistry from Uppsala University.
The aim for Karin is to share her knowledge and broad regulatory expertise within medical device – to benefit for customers, patients and healthcare.
Jennie Andersson, Senior consultant
PhD
jennie.andersson@regsmart.se
+46 (0)730 – 797 397
Jennie has a PhD in pharmaceutical sciences, and has been engaged in several projects aiming at improving diagnostics and care for prostate cancer patients.
The last ten years, Jennie has worked as regulatory consultant offering advice and interim management services to medical device manufacturers. Her main expertise is in diagnostics (IVD). During the pandemic, Jennie served as COO at a lab providing covid-19 diagnostic testing for the regions in Sweden.
Jennie is looking forward to support within her regulatory expertise area, for example to help manufacturers with legacy products understand and bridge the gap between IVDD and IVDR.
Mats Artursson Senior consultant
M Sc, Mechanics
mats.artursson@regsmart.se
Mats is a medical device software expert, with vast experience from both authorities and the medtech industry. Most recently, Mats worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for eight years, as Assessor and Inspector, responsible for in-depth investigations of market surveillance cases with focus on medical device software and medical information systems.
Mats has been involved in creation of Guidance on the MPA’s regulation (LVFS 2014:7) regarding National Medical Information Systems and he has been a member of IMDRF Software Working Group implementing four guidelines for Software as a medical device, SaMD,
In addition, Mats served as Sweden’s representative in the EU Commission’s Software Working Group both as delegate and group leader, implementing guidelines for Medical device software and chaired a working group at the Swedish Standard Institute, SIS, implementing a standard for health applications.
Prior to working at the Swedish Medical Products Agency, Mats has worked with development of medical device software since 1985 in leading positions at Siemens and St. Jude Medical.
He holds a M Sc in Mechanics from Lund University.
Mats looks forward to helping customers to put new, inventive and safe medical products to market with the ultimate goal to improve life quality of patients.