In the late 90-ies, there was a concern among regulators and health care professionals that too few products targeting the unmet need in rare diseases were put on the market. Patients had very few treatment alternatives and if any, those were often off-label treatment with limited documentation to support their efficacy and safety. Something has … Continue reading New incentives for orphan products on its way
The countdown has started. On 26th of May the In Vitro Diagnostic Regulation, also known as IVDR, is entering into force. The aim of the regulation is to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic devices (IVDs), which ensures a high level of safety and health whilst supporting innovation. … Continue reading IVD manufacturer – use the progressive roll-out of IVDR in a smart way
Welcome Anders Juréus! On April 19 you joined our team as senior consultant drug development. What is your background, prior to joining RegSmart? I have extensive and broad drug development experiences from the pharmaceutical industry as well as academia and regulatory authorities. Most recently, I come from the Swedish Medical Products Agency were I held … Continue reading Welcome to RegSmart, Anders Juréus, senior consultant drug development
The first episode of the podcast Idé till patient (Idea to patient) will be released on April 12. The podcast series is a co-production between the companies within the CTR-group and SwedenBIO. The series comprises six episodes where invited guests from the pharma industry will be discussing the pitfalls and highlights in early drug development. … Continue reading CTR launches podcast together with SwedenBIO
Earlier this year, Center for Translational Research (CTR) revealed the establishment of a new regulatory company, RegFile AB, complementing RegSmart in its services. RegFile, led by CEO Maria Santesson, is now ready to start providing regulatory affairs support to customers. Maria Santesson is one of the founders of RegFile and will start as the new … Continue reading RegFile is now in operation
Welcome Anna Wannberg! On March 28 you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Well, I have a long regulatory background, for the last ten years at the Swedish Medical Products Agency, MPA. My main focus there was regulatory questions, such as borderline and classification, but also … Continue reading Welcome to RegSmart, Anna Wannberg, senior consultant medical devices
It is exciting times ahead for those interested in the future regulation of pharmaceuticals. It should be a priority not only for regulatory nerds like myself. Much have happened since the last update of the EU legislation. New technology has led to increase of the understanding of disease mechanisms and design of “targeted therapies” that … Continue reading Finally time for revision of the EU pharma legislation
The mission is to support clients with regulatory affairs services in connection to, and beyond, their regulatory submissions for marketing approval. CEO will be Maria Santesson. “It is with great enthusiasm I take on the task of setting up operational regulatory consulting within CTR, and I look forward to working with all the dedicated experts … Continue reading CTR establishes regulatory company, complementing RegSmart
Welcome Karin Westermark! On February 1, you joined our team as senior consultant in medical devices. What is your background, prior to joining RegSmart? Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for six years – first as Assessor and the last three years as Senior Assessor … Continue reading Welcome to RegSmart, Karin Westermark, senior consultant medical devices
Most welcome, Gunilla Nygård! On January 10, you joined RegSmart as senior project management consultant, adding a new service and key competence to our team of senior regulatory experts. What is your background? I have almost twenty years of experience from global drug development and project delivery at Astra Zeneca, from early phase to approval … Continue reading Welcome to Regsmart, Gunilla Nygård, senior project leader
