Write to the Editor at firstname.lastname@example.org
January 2023 | Volume 20 | No.1
The drug development paradigm is shifting to deliver medicines that patients truly value. It is now recognised that improved patient involvement can drive the development of innovative medicines that deliver more relevant patient outcomes.
By Kasia Nowok and Richard Huckle
Following the launch of Regulatory Rapporteur’s online publishing platform earlier this year, this article discusses how the journal’s platform will provide the best possible online experience for its members.
By Alan Booth
LETTER TO THE EDITOR
In this Letter to the Editor, the author discusses her career in quality, spanning more than 20 years. She talks about the importance and success of collaboration in the field, and the negative aspects of policing.
By Nathalie Bouchard
Dr Francesco Pignatti, Head of Oncology and Haemotology at the EMA, discusses the Agency’s patient-centric approach to medicines evaluation, and the importance of collaboration in drug development and regulation.
By Kasia Nowok
Patient experience data (PED) provides information about patients’ experiences with a disease or condition. Industry and regulators need to work more collaboratively on PED generation, and this article looks at the benefits of an integrated approach to colllecting PED.
By Kerrie-Anne Ho
Regulatory authorities encourage the submission of patient preference information (PPI), which captures the value patients place on features of medical devices. This article provides an overview of PPI and regulatory guidance for developing and submitting this information.
By Kerrie-Anne Ho and Carol Mansfield
The EU Clinical Trials Regulation (EU CTR) came into effect on 31 January 2022. This article provides guidance on investigational medicinal product dossier requirements, for sponsors planning to submit clinical trial applications via the EU CTR. Potential challenges are also discussed.
By John Watkins and Morgane Lejeune
Regulatory authorities charge fees for their services related to marketing authorisations. This research explores the fee calculation and payment process for EU procedures used for the market approval of a drug. It also proposes solutions to improve efficiency.
By Charlene Senanayake
Regulations are always evolving to meet the needs of changing technologies, and regulatory affairs professionals must meet these ever-changing requirements. This article looks at innovative approaches to meet the different priorities whihc aim to reduce budget.
By Caroline Kuhn, François Hebraund, and Vijay Reddi