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.
EditorialSustainable pharmaceuticals
In this bumper July/August edition of Regulatory Rapporteur, we focus on sustainability and, in many aspects, we build upon our June theme of access to medicines. Sustainability in pharmaceuticals encompasses a broad range of practices aimed at minimising the environmental, social and economic impact of pharmaceutical production, distribution and consumption.
EditorialThe global access battle for healthcare equity
The World Health Organization (WHO) has estimated that one-third of the global population lacks regular access to essential medicines. The concept of access to medicines will likely resonate differently within the various regulatory speciality areas, however there are ultimately five common factors that include availability, affordability, accessibility, acceptability and quality.
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.