Chcuk Ltd

15/03/2018

Until now there’s the voices of patients have been absent from healthcare's AI conversations. To change that, we surveyed patients and caregivers to learn about their expectations, hopes and concerns for AI in healthcare. Download the report here:

Over 2017, Artificial Intelligence became a mainstream topic of conversation, with industry, investors and the media discussing its possible impact on all areas of our personal and professional lives.

15/03/2018

My colleagues Rachel Stahler and Michelle Keefe share their lessons learned throughout their careers in this PharmaVOICE article on female leaders. Each of their stories are so inspiring!

15/03/2018

Survey Says... Less than 20% of patients are open to replacing physicians - Read more here:

Lack of human oversight enhances fear of machine errors

09/03/2017

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,

What are the real-world evidence tools and how can they support decision making? Output from EMA-EuropaBio Info Day – 22nd November 2016

07/03/2017

PRIME (PRIority MEdicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need.

PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need.

03/03/2017

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,

The 4th law on the amendment of the German Drug Act came into force on Dec 24, 2016. Changes related to NIS were made in Articles 63 f and 67 (6) AMG

03/03/2017

Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health

An important modification of the French research law framework occurred in November 2016 with the coming into force of decree No. 2016-1537.

Decree No. 2016-1537 came into force in November 2016. NIS must now be notified to ANSM and CPP approval gained if patients are involved.

14/02/2017

In mid-November 2016 the government issued directives to review the pricing and reimbursement system and the national financing system for medicinal products.

12/02/2017

18 January 2017 - the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties,

New draft guidance documents provide clarity on FDAs position based on the changes to FDAMA144 implemented through Section 3037 of the 21st Century Act

30/01/2017

The long-awaited decree that clarifies the French "Sunshine" obligations was recently published in the French Official

23/01/2017

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation",

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation"of ICH E8 and E6. Deadline 11 Mar 2017

20/01/2017

The U.S. Department of Health and Human Services and 15 other federal agencies today (19 January 2017) issued a final

19 Jan 2017 - The U.S. Department of Health and Human Services issued final rule to update Common Rule. Most provisions will go into effect in 2018.