SME

Regulatory Affairs & Quality Assurance: Copenhagen

Regulatory Affairs & Quality Assurance: Copenhagen

Jakob Sandersen reflects on over a year of regulatory work from S-cubed Pharmaceutical Services ApS based in our Copenhagen Office. [caption id="attachment_3886" align="alignright" width="159"] Jakob Sandersen, Director, Regulatory Affairs[/caption] We started regulatory affairs and quality assurance activities out of our…
SME Day at EMA – Part 3

SME Day at EMA – Part 3

In the final part of our series reporting from the SME Day at EMA, Larissa Gould focuses on the update from the Committee for Advanced Therapies, new Medical Devices Regulation and a Brexit update. Read part 1 | Read part 2 Don't…
SME Day at the EMA – Part Two

SME Day at the EMA – Part Two

Part Two of Larissa Gould's report from the EMA focuses on the different types of legal basis for Marketing Authorisation in the EU and the impact of the Commission notice on the application of Articles 3, 5 and 7 of Regulation…
SME Day at the EMA – Part One

SME Day at the EMA – Part One

Regulatory Toolbox for Medicines and Combined Device Developers We will be releasing this information in 3 parts - so keep an eye out for Part 2 next week. Larissa Gould reports from the EMA in Canary Wharf on the latest…