EMA has launched a new pilot to assess whether the analysis of ‘raw data’ by regulatory authorities improves the evaluation of marketing approval for new medicines. The pilot will run for 2 years starting in September. Still, regulatory decisions within EU are based on the assessment of applicant’s own analyses, which in turn must be thoroughly … Continue reading Potential step change – EU regulators get to play with data
– soon in a pharmacy near you? Generic competition is an effective way to push down drug prices, but it has not worked equally well for biosimilars. Biosimilars require more time to gain market share compared to generics, and new biosimilars do not always lead to lower prices. In a report to the Swedish government … Continue reading Interchangeable biological medicines
Does the introduction of MDR and IVDR mean that we risk losing important medical technology innovations? Do the tightened rules make the certification process so complex that start-up companies simply do not participate and give up, with the result that important innovations that can improve care never reach the market? What can we do in … Continue reading ”Do we have the right balance between risk and patient benefit?”
In September, you joined the RegSmart team as senior consultant medical device and pharmaceuticals. What is your background, prior to joining RegSmart? Since qualifying as a Pharmacist many years ago the main focus of my career has been within the Pharmaceutical and MedTech industry. Beginning with joint QA/RA roles I subsequently focused on Global Regulatory … Continue reading Welcome to RegSmart, Sinéad Breen, senior consultant
One of the more important aims of the EU pharmaceutical legislation is to ensure access to affordable medicines to all patients in the region. A new product, for example to treat cancer, should be available for all EU patients, including those in the smaller member states. The reality, however, is that many of the new … Continue reading ”The situation is not satisfactory”
This autumn, you joined the RegSmart team as senior consultant medical device and IVD. Tell us, what is your background prior to joining RegSmart? I have a PhD in pharmaceutical sciences but instead of pursuing an academic career, I started my own consultancy business. Consultancy suited me well, and for the last decade I have … Continue reading Welcome to RegSmart, Jennie Andersson, senior consultant medical device
You have been a part of the life science industry for more than 30 years, and are a familiar face to many of us. You also hold a PhD and are Associate Professor in Physical Chemistry at KTH in Stockholm. Tell us, what is your background within life science? I have been responsible for pharmaceutical … Continue reading Welcome to the RegSmart team, Torbjörn Wärnheim!
On June 1, you joined the RegSmart team as Director medical device and IVD, with a senior consultant role. Tell us, what is your background prior to joining RegSmart? I am a senior executive with global experience in the medical technology and life sciences market. Over the past 30+ years, I have worked in several … Continue reading Welcome to RegSmart, Mats Högberg, Director medical device and IVD
You have just joined our team as senior consultant, drug development. What is your background, prior to joining RegSmart? I am 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, I come from the Swedish Medical Products Agency, … Continue reading Welcome to RegSmart, Eva Ragnarsson, senior consultant drug development
Many people are dependent on their pacemaker to live normal lives. It is an ingenious innovation – but did you know that it is a Swedish invention? Mats Artursson, senior consultant at RegSmart, has been deeply involved in the pacemaker development since the 1980s. Up to 700 developers in Sweden, US and India contributed along … Continue reading What would a pacemaker be without medical device software?
RegSmart has teamed up with LBR Regulatory as US Agent partner, and offer full support for non-US companies to introduce projects to FDA in a cost effective way. Why an US Agent? For foreign pharmaceutical or medical device companies to enter the US pharmaceutical market, you need to have an authorized US Agent, acting like … Continue reading Planning to open an IND in US?
