Regulatory
Rapporteur
Write to the Editor at publications@topra.org
January 2023 | Volume 20 | No.1
EDITORIAL
Patient evidence and engagement
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.
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By Kasia Nowok and Richard Huckle
COMMENTARY
’Science is more than a body of knowledge’
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.
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By Alan Booth
LETTER TO THE EDITOR
Quality: partnering rather than policing?
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.
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By Nathalie Bouchard
FOCUS
Every patient has a story to tell us
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.
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By Kasia Nowok
FOCUS
An integrated approach to collecting patient experience data:
an industry perspective
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.
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By Kerrie-Anne Ho
FOCUS
The application of patient preference information
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.
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By Kerrie-Anne Ho and Carol Mansfield
FOCUS
Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR
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.
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By John Watkins and Morgane Lejeune
FEATURE
European regulatory fees – complexity, concerns, and solutions for efficiency
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.
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By Charlene Senanayake
FEATURE
Case study: the evolving regulatory environment
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.
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By Caroline Kuhn, François Hebraund, and Vijay Reddi
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