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?

READ HERE
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.

READ HERE
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.

READ HERE
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.

READ HERE
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.

READ HERE
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.

READ HERE
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.

READ HERE
By Syed Ziauddin Hashmi

PODCAST

RegRapPod June 2023

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.

LISTEN HERE
By Alan Booth and Sarah Roberts