Are you Pharmacovigilance inspection-ready?

If not – we are here for you. We have long experience from the pharmaceutical industry, government inspections and expertise in pharmacovigilance legislation. We perform audits of marketing authorisation holder (MAH), partner companies and service providers to identify GAPS in the pharmacovigilance system.

Welcome to RegSmart, Sari Öbrink

This spring, you joined the RegSmart team as senior advisor pharmacovigilance. Tell us, what is your background prior to joining RegSmart? Since I thrived for working with patient safety, I took the opportunity to join a consultancy company as a pharmacovigilance consultant.

Interchangeable biological medicines

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.

“Do we have the right balance between risk and patient benefit?”

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 the short term to avoid this happening?

Welcome to RegSmart, Sinéad Breen, senior consultant

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.

“The situation is not satisfactory”

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.