Regulatory Rapporteur
Write to the Editor at publications@topra.org
June 2023 | Volume 20 | No.6
EDITORIAL
Clinical trials:
Ethical, ecological and economic change
In the pursuit of global – or even regional – standards in requirements to support medical product development; is industry keeping up? Can regulations and guidelines keep up with the pace of change?
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By Sarah Roberts
FOCUS
Decentralised clinical trials –
an EU recommendation paper
Decentralised clinical trials (DCTs) have undergone rapid development over the last three years, bringing benefits to patients, sites, and sponsors. This article provides EU guidance for conducting DCTs and recommendations for protocol and informed consent.
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By Pedro Barroso Inacio and Stefani Dilova
FOCUS
First experiences with the Clinical Trial
Regulation – a company perspective
The Clinical Trials Regulation (CTR) replaced the Clinical Trials Directive (CTD) in January 2022. This article reports on Merck KGaA’s early experience with clinical trial applications (CTA) under the CTR, compared to its previous experience with CTAs under the CTD.
By Christopher Price, Elmar Schmitt, Martina Hoeth,
Georgios Amexis, Alexa Hunter and Lisette Vromans
FOCUS
Regulation (EU) No 536/2014 –
first experience from a CRO perspective
The EU Clinical Trials Regulation (CTR), effective from 31 January 2022, has introduced significant changes to the clinical trials application process. This article summarises the experience gathered under the CTR from the perspective of a contract research organisation.
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By Ana Velimirovic, Britta Dieckhoff, Elisaveta Parapiteva,
Iris Romero Matuschek, Polly Halliday and Vicki Iassonidou
FOCUS
Processes when seeking scientific
advice in the EU and USA –
is there a difference and does it matter?
All major regulatory agencies provide scientific advice to pharmaceutical companies developing new medicines. The EMA and FDA have different procedural approaches to scientific advice, meaning that companies seeking advice must tailor their plans. This research paper compares the two agencies’ procedural appraoches. This is the first article in a two-part series.
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By Hilary Gray
FEATURE
Medical device standards update
This edition of our regular feature updates on the progress of applicable standards for medical devices and in vitro diagnostic devices to March 2023.
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By Mehyrar Behizad
FEATURE
Reappraisal of regulation of agricultural
and veterinary chemicals in Australia
The Agricultural and Veterinary (Agvet) Chemicals Legislation Amendment (2014) means that Agvet products receive reapproval unless new evidence demonstrates harm to Australia’s environment. This article summarises this legislation and its impact on Australia’s Agvet market.
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By Syed Ziauddin Hashmi
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