In the May issue of the TOPRA journal, Regulatory Rapporteur, members of Boyds’ award-winning regulatory team made significant contributions to the respected, international peer-reviewed journal.
In this month’s edition of the Regulatory Rapporteur, Sabine Ruehle, Associate Director, Regulatory Affairs at Boyds, co-authored an article titled “Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR”. The article discusses the specificities of the new CTR process for GMO-IMPs and updates on the GMO application processes in light of these changes. Read the article here.
Contributions were also made by Boyds’ Vice President, Regulatory Affairs, Julie Warner and Associate Director, Regulatory Affairs, Harriet Edwards who co-edited the May edition, which focuses on advanced therapies. Harriet also authored an article on gene editing, titled ‘G-E-T-ting there – how gene editing technologies could change more than genes’. The article discusses the current regulatory landscape for gene editing technologies and what the future may hold for regulation of these life-changing medicines.