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

China Coronavirus Cases Up Sharply As Pharma Rushes To Aid

By Brian Yang 27 Nov 2020

AbbVie’s HIV therapy Kaletra is now being used by the Chinese government to treat coronavirus-infected patients after a respiratory expert endorsed its use, while other pharma companies from Bayer to Innovent are showering support as China battles its worst virus outbreak since the SARS epidemic 17 years ago.

Topic China Coronavirus Policy & Regulation Risk Management

Pink Sheet

A Visual Guide To US FDA's Evolutionary Decade In Review

By Brenda Sandburg 27 Nov 2020

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

Topic FDA Policy & Regulation

Pink Sheet

US Drug Pricing Reform Post-Election: Scenarios To Consider And Lessons Learned

By Cathy Kelly 18 Nov 2020

Regardless of the outcomes of the US elections, drug pricing is likely to take a back seat to COVID as policy focus. But the pandemic does offer pharma an opportunity for partnerships with payers on health outcomes. Commonwealth Fund’s Liz Fowler, South Capitol’s John O’Brien and ICER’s Steve Pearson discuss where drug pricing stands in public opinion, whether policies embraced by President Trump will have staying power, and the conditions needed in the policy environment for major change.

Topic US Election 2020 Policy & Regulation Drug Pricing

Pink Sheet

US Election 2020: Trump's Sway Over Courts Expected To Linger

By Elizabeth Orr 09 Oct 2020

Textualist judges appointed by President Trump during his term may block a potential President Biden’s attempts to shift the government’s legal policies.

Topic US Election 2020 Policy & Regulation

Pink Sheet

'No Turning Back' On Regulatory Changes at UK MHRA

By Ian Schofield 02 Oct 2020

The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.

Topic Policy & Regulation Brexit