All Regulatory Rapporteur articles in May 2024
View all stories from this issue.
-
PodcastsRegRapPod − In Conversation with Bengt Mattson
BONUS EPISODE: In Conversation talking sustainability with Bengt Mattson
-
PodcastsRegRapPod − May 2024
Vol.21 #5: In May 2024’s RegRapPod, host Alan Booth talks to Issue Editor Harriet ‘Podcast’ Edwards about her specialist subject ATMPs.
-
JournalThe European Association of Authorised Representatives
This is the first instalment in a three-part series examining the statutory functions with respect to medical devices and in vitro diagnostics that flowed from the enactment of the European Union’s (EU) Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) and ...
-
-
EditorialUnlocking a new paradigm of healthcare through advanced therapies
Regulatory Rapporteur May 2024 | Volume 21 | No.5 It seems like a recurring theme to start our advanced therapy medicinal products (ATMPs) issue with a familiar message: we are undoubtedly entering a new paradigm of ...
-
JournalThe first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract Patients with transfusion-dependent β-thalassemia and severe sickle cell disease suffer the burden of repeated blood transfusions and vaso-occlusive crises, respectively. Casgevy (exagamglogene autotemcel) consists of autologous CD34+ haematopoietic stem ...
-
JournalMedical device standards update: March 2024
This edition of our regular column updates the progress of applicable standards to March 2024
-
-
JournalNavigating the process complexities and challenges associated with EU-CTR transition applications
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract From 31 January 2025, clinical trials authorised under the old EU Clinical Trial Directive (CTD) must either have ended in the EU/EEA or have been transitioned to new EU ...
-
-
InterviewDr Peter Marks on reflecting innovation through FDA regulation
Harriet Edwards and Dr Katherine Bowen spoke to Dr Peter Marks, Director of Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), about his career and the continued evolvement of regulation to support innovative medicines development
-
PodcastsRegRapPod − In Conversation with Helena Corte-Real
BONUS EPISODE: In Conversation talking careers with Helena Corte-Real