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China – Key Considerations in Using Real-World Evidence to Support Drug Development

China – Key Considerations in Using Real-World Evidence to Support Drug Development

by Syneos Health_1 | 30 May, 2019 | CHCUK News & Articles, Consultation, Real Word Evidence, Real World Research Design, Regulatory Grade RWE

May 2019 – the Center for Drug Evaluation (China) has released a draft document for public review on “Key Considerations in Using Real-World Evidence to Support Drug Development” Background and Purpose Randomized Controlled Trials (RCTs) are...
Potential for use of Electronic Healthcare Databases (EHDs) in Medicines Regulation

Potential for use of Electronic Healthcare Databases (EHDs) in Medicines Regulation

by Syneos Health_1 | 19 Nov, 2018 | CHCUK News & Articles, Digital Health Technology, Real Word Evidence

Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation Source: Pacurariu A, Plueschke K, McGettigan P, et al. Electronic healthcare databases in Europe: descriptive analysis of characteristics...

Trump Administration Announces MyHealthEData Initiative at HIMSS18

by chuck_ltd | 30 Mar, 2018 | 21 Century Cures Act, Cures Act, EHR, Real Word Evidence, Virtual Clinical Research

The Trump Administration is launching the MyHealthEData initiative which aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure CMS is committed...

RWE – What are the Opportunities across the product life cycle?

by chuck_ltd | 9 Mar, 2017 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry

What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day – 22nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology Department, EMA [View Slide Deck…] RWE –...

Germany – Impact of Amendment of the German Drug Act on NIS

by chuck_ltd | 3 Mar, 2017 | CHCUK News & Articles, News, NIS, NIS Considerations Report, Regulatory Intelligence

The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on...
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