Sophie Bertilsson, Senior Consultant at RegSmart

Welcome to RegSmart, Sophie Bertilsson, senior consultant, CMC and pharmaceutical development


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

Welcome to RegSmart, Brita Liljestrand, senior consultant in medical devices!


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!

Karin Meyer, ny VD för CTR

Karin Meyer blir ny VD för Center for Translational Research Sweden AB (CTR)


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)

Do FDA and EMA talk to each other?

Do EMA and FDA talk to each other?


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?

Ira Palminger Hallén

New senior consultant: Ira Palminger Hallén


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