TrialScope Disclose

Clinical Trial Transparency Policy

07 Feb 2022

Disclosure requirements are numerous and ever evolving. Study sponsors need a transparency policy that addresses disclosure, transparency, and data sharing.

Topic Policy & Regulation

TrialScope Disclose

Clinical Trial Information System (CTIS)

14 Sep 2021

Created by the European Medicines Agency (EMA). Stakeholders will use CTIS to: Submit and approve clinical trial applications (CTAs), Submit trial reports, results and notifications, Communicate centrally with the Member States Concerned (MSC) in the clinical trial

Topic Policy & Regulation Clinical Trials Clinical Trials Blog

Generics Bulletin

EU Reforms Must Heed Pandemic Lessons

By David Wallace 08 Dec 2020

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged

Topic Coronavirus EU Policy & Regulation

Generics Bulletin

EU Reforms Must Heed Pandemic Lessons

By David Wallace 29 Nov 2020

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.

Topic Coronavirus EU Policy & Regulation

Scrip

Health Sector On High Alert As Wuhan Coronavirus Spreads

By Brian Yang 27 Nov 2020

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

Topic China Infectious Diseases Policy & Regulation Coronavirus

Medtech Insight

Diagnostics Industry In Spotlight As Germany Doubles Down To Prevent Second COVID-19 Wave

By Ashley Yeo 27 Nov 2020

Germany’s authorities are back on guard against COVID-19 following renewed regional outbreaks. Diagnostics manufacturers will continue to play a strong part in bringing the pandemic substantially under control, a recent industry association virtual conference heard.

Topic Coronavirus Policy & Regulation

Medtech Insight

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

By Sue Darcey 27 Nov 2020

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Topic Approvals Clinical Trials Coronavirus Policy & Regulation

Generics Bulletin

California Plans To Create Own Generics Label

By Aidan Fry 27 Nov 2020

California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.

Topic Legislation Policy & Regulation

Medtech Insight

EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

By Amanda Maxwell 21 Oct 2020

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

Topic EU Policy & Regulation