All Regulatory Rapporteur articles in June 2023
View all stories from this issue.
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PodcastsRegRapPod – June 2023
Vol.20 #6:
In the June 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Sarah Roberts about the state of play for research under the new EU Clinical Trials Regulation, from the perspective of pharma and the contract research organisations. -
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JournalDecentralised clinical trials –
A European Union recommendation paperDecentralised clinical trials (DCTs) have undergone a rapid development over the last three years. This article focuses on the recently published European Union (EU) recommendation paper which provides consolidated guidance for sponsors planning DCTs irrespective of any health-related crisis, as part of the Accelerating Clinical Trials in the European Union ...
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EditorialClinical trials:
Ethical, ecological
and economic changeIn 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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JournalReappraisal of regulation of agricultural and veterinary chemicals in Australia
Agricultural and Veterinary (Agvet) chemical products are registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA) before they can be supplied in Australia. A mandatory scheme was introduced by the Australian government in 1993 to transfer Agvet chemical products from the State-based system to a national ...
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JournalMedical device standards update: June 2023
This edition of our regular column updates the progress of applicable standards to March 2023.
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JournalImplementation of Regulation (EU) No 536/2014 – A CRO perspective
Significant changes have been implemented to the clinical trials application process with Regulation (EU) No 536/2014 (European Union Clinical Trials Regulation; EU CTR) taking effect on 31 January 2022. This article summarises experience gathered under the new regulatory framework from a contract research organisation (CRO) perspective working ...
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JournalA critical review and comparison of the processes when seeking scientific advice in the EU and the USA – Part 1
GRAY, MSc − PART ONE OF A TWO-PART SERIES(See part 2 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory Agencies such as EMA and FDA regard provision of SA as a core ...