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.

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

Generics Bulletin

EU Reforms Must Heed Pandemic Lessons

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

EU Reforms Must Heed Pandemic Lessons

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.

10 Predictions On How Health Policy Could Change Under A Biden Presidency

29 Nov 2020

Health policy changes that President-elect Joe Biden will likely make during his four-year term include Medicaid expansion and a greater reliance on medical science, among others, experts say.

How To Negotiate With Public Payers: Five Lessons - And A Few Cautions - From The UK's New Pact On Drug Price And Access

27 Nov 2020

In today’s globalized market for medicines, national rules on pricing and access are abundantly shared and more transparent than opaque. In Vivo speaks to the UK branded industry’s negotiator for the latest five-year joint pricing pact with the government, Richard Torbett, who outlines, among other topics, five widely applicable precedents from the talks that can work in “getting to yes” – despite the fractious budgetary climate for health care evident in all major country markets. 

Health Sector On High Alert As Wuhan Coronavirus Spreads

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.”

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

27 Nov 2020

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

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

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.