Sophie is an expert on chemical/pharmaceutical aspects of drug development. Most recently, Sophie comes from the Swedish Medical Products Agency (MPA), 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. She has over 15 … Continue reading Welcome to RegSmart, Sophie Bertilsson, senior consultant, CMC and pharmaceutical development
Brita is an expert in medical device regulations (MDD/MDR) and has a long experience of use and maintenance of medical devices in the health care environment. She has a long regulatory background and has worked for the Swedish Medical Products Agency (MPA) for the last 12 years. Brita has worked with inspections of manufacturers, and … Continue reading Welcome to RegSmart, Brita Liljestrand, senior consultant in medical devices!
Center for Translational Research Sweden AB (CTR) acquires Toxicology Knowledge Team Sweden AB (TKT) further strengthening the CTR group with optimised toxicological support. From April 1, TKT is a fully owned subsidiary to the holding company CTR. The activities at TKT will continue without interruption and with the same staff, in the same facilities in … Continue reading CTR acquires preclinical toxicology company
Welcome to RegSmart, Katarina Andersson, senior consultant! Our new senior consultant 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 … Continue reading New senior consultant: Katarina Andersson
“Drug repurposing” is finding new therapeutic use of substances no longer protected by patent or regulatory exclusivity. This route is actively pursued by parts of the pharmaceutical industry. But what if there is a high unmet medical need and no commercial interest? This is something that has concerned the European Commission in Brussels. Let us … Continue reading Repurposing as a golden ticket to approval?
Our new senior consultant 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. … Continue reading Welcome to RegSmart, Robert Hägerkvist, senior consultant!
Rapid developments in technology have led to the possibility for generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? The question was addressed by the HMA/EMA task force on Big Data with the aim to “…inform strategic decision-making and planning and to … Continue reading Big data evidence generation drives change in EU regulatory system
CTR tillkännager att styrelsen har utsett Karin Meyer till ny verkställande direktör. Karin Meyer efterträder Mats Lindquist som varit verkställande direktör sedan starten av CTR 2016. Karin Meyer har en lång erfarenhet av ledande befattningar inom läkemedels- och biotechindustrin, god branschkännedom och en mycket god förståelse för utveckling av nya produkter inom dessa områden. Karin, … Continue reading Karin Meyer blir ny VD för Center for Translational Research Sweden AB (CTR)
Of course they do! The collaboration between EMA and FDA formally started already in 2003. Today the two agencies have almost daily interactions, with the aim to better align, and advance scientific and regulatory excellence worldwide. Already from the start, assessment of oncology‐hematology medicines was discussed. Over the years, groups have been created to cover … Continue reading Do EMA and FDA talk to each other?
We are happy to welcome Ira Palminger Hallén to RegSmart! 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 … Continue reading New senior consultant: Ira Palminger Hallén