Davina Stevenson
Davina is the Editor-in-Chief of the Regulatory Rapporteur. Davina has expertise in global regulatory strategy across the product lifecycle, and also process and system improvement. Regulatory experience spans oncology, analgesia and liver disease therapeutic areas, orphan and generic drug development. Davina is a Chartered Scientist, TOPRA Fellow and holds a Regulatory Affairs MSc with focus on Regulatory Intelligence.
EditorialAdvancing global
healthcare togetherAn annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for human and veterinary medicines, medical devices and IVDs. This year the Symposium was in Lisbon, in partnership with Infarmed, Portugal’s national authority of medicines and health products.
CPD SupplementThe Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
CPD SupplementExpedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.