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96 Total results for product and free and sample content found

TrialScope Disclose: The most widely used pla...

Clinical Trial Transparency Policy

07 Feb 2022

Clinical Trial Transparency Policy

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

Topic policy-and-regulation

TrialScope Disclose: The most widely used pla...

Clinical Trial Information System (CTIS)

14 Sep 2021

Clinical Trial Information System (CTIS)

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-and-regulation clinical-trials clinical-trials-blog

Generics Bulletin: ジェネリック&バイオシミラーニュース

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-and-regulation

Generics Bulletin: ジェネリック&バイオシミラーニュース

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-and-regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

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.

Topic US Election 2020 Leadership Policy & Regulation

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

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. 

Topic brexit policy-and-regulation

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

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.”

Topic China Infectious Diseases Policy & Regulation Coronavirus

Medtech Insight: 世界の医療機器・医療技術の最新情報

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

By Sue Darcey 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.

Topic drug-approval clinical-trials Coronavirus policy-and-regulation

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