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?
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
Drug development create new challenges for regulators
Do regulatory agencies approve new medicines earlier and with less data today compared to before? This is a question that has been raised during recent years, but is there some truth in this? The basis for regulatory approval of a new drug is that positive benefit-risk profile has been proven. This decision is based on … Continue reading Drug development create new challenges for regulators
Can regulators keep up with innovation?
New technology has increased the understanding of disease mechanisms and enabled approval of products targeting small but specific patient populations; sometimes referred to as precision medicine. Gene- and cell therapies have reached the market, exemplified by CAR-T cells, and the research pipeline is promising. In addition, the medical device field is constantly growing creating new … Continue reading Can regulators keep up with innovation?
Brexit looking back and looking forward
More than 3 years have passed after the vote and there is still uncertainty around the outcome. At this date, however, the UK prime minister has stated very clearly that he will deliver Brexit the last of October. The discussion of the potential consequences for the Life Science business started soon after the vote. Great … Continue reading Brexit looking back and looking forward
Meet us at NLS Days 2019!
RegSmart are excited to announce that we will attend the Nordic Life Science Days 2019 in Malmö, Sweden, the 10-12th of September. We are happy to tell you all about how we can help you navigate in a complex and evolving regulatory landscape. With our long regulatory experience from senior positions at a regulatory agency … Continue reading Meet us at NLS Days 2019!
New senior consultant: Agneta Larhed
Agneta Larhed has joined RegSmart AB as a senior consultant with focus on pharmaceutical development and quality/CMC. RegSmart is a newly started regulatory consultancy firm based in Uppsala. Agneta has a broad experience within formulation development and regulatory quality documentation. In addition, she has been active as a manager and researcher within both industrial pharmaceutical … Continue reading New senior consultant: Agneta Larhed
Center for Translational Research AB establishes a new regulatory company
Center for Translational Research AB (CTR), holding company for CTC Clinical Trial Consultants AB, starts a new regulatory consulting company with focus on pharmaceuticals and medical device. Marie Gårdmark has been assigned as CEO for the new corporation. The company will be further strengthened with senior regulatory competence within the areas of medical device and … Continue reading Center for Translational Research AB establishes a new regulatory company