Articles

A discussion of various topics amongst TMF experts from Questex’s 2020 Global TMF Summit. 

Update on Maintaining TMF Quality

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

While the UK's departure from the EU is imminent, NICE will continue to influence thinking around the continent. 

The Ever-Changing Face of NICE Guidance on Drug Innovation

Cue Biopharma has managed to persevere through the COVID pandemic by employing a variety of strategies. President and Chief Scientific Officer, Anish Suri, and Ken Pienta, acting Chief Medical Officer discuss their experiences.

New Oncology Therapies Emerge Amidst COVID Pandemic

President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.

Tackling COVID Top Priority for New Administration

A discussion of how sponsors, CROs, and sites are adapting their operational models to maintain patient safety, data quality, and integrity in the COVID-19 pandemic. 

Clinical Quality and Operations During the Pandemic

With various COVID-19 vaccine trials underway, a seamless clinical research process has never been more critical. 

How to Navigate the Clinical Trial Complexities in a Post-COVID World

Dilemmas are multiple and stakes are high as the framework for thinking about medicines development frequently fluctuates because of the COVID-19 pandemic, making it harder to foresee all implications for the future.

COVID-related Changes have Implications Not Just for Innovation but Also for Public Acceptance of Innovation

Both quality personnel and the FDA have predicted some of the issues with pandemic operations, but much is still unknown on the impact these rapidly implemented pandemic processes.

Clinical Trial Quality Concerns Arise Amidst COVID

As the EU moves towards the next stage in its review of intellectual property incentives for pharmaceuticals, some unusually direct exchanges occurred between those who advocate patents—and those who oppose them.

Patents as a Barrier or an Enabler to Innovative Medicines: Europe's Debate Sharpens Up

Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.  

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