chcuk@syneoshealth.com
  • Home
  • Contact
CHCUK
  • NIS
    • NIS Definitions
    • Study Classification
    • NIS Training Solutions
    • NIS Country-Specific Reports
    • NIS Regulatory Database
    • NIS Regulatory Consulting
    • NIS Resources & Useful Links
    • RWR Glossary
  • PCTs
    • PCT Definitions
    • PCT Regulatory Consulting
    • PCT Useful Links
    • RWR Glossary
  • GCP
    • GCP Definitions
    • GCP Useful Links
    • RWR Glossary
  • News
  • About
  • Contact
Select Page

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...

Finalised FDA Guidance – Use of Electronic Informed Consent

by chuck_ltd | 1 Jan, 2017 | CHCUK News & Articles, Digital Health Technology, GCP, News, Virtual Clinical Research

Finalised FDA Guidance Published December 2016 This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance is intended for...

Reform of EU Data Protection Rules

by chuck_ltd | 10 May, 2016 | CHCUK News & Articles, Data Privacy, News, Virtual Clinical Research

The EU Data Protection legislation has been reformed. On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonised data protection framework across the EU. The...

Implementation of the Hong Kong Electronic Health Record Sharing System

by chuck_ltd | 29 Apr, 2016 | CHCUK News & Articles, Data Privacy, EHR, Virtual Clinical Research

The Electronic Health Record Sharing System Ordinance came into effect on 2 December 2015. The Ordinance provides the legal framework for public and private hospitals and other healthcare providers to collect, share and keep patient’s electronic health record...

Mytrus Technology Chosen for ADAPTABLE Aspirin Pragmatic Trial

by chuck_ltd | 16 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, News, Patient Centricity, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

Davis, CA. – March 07, 2016 – Mytrus, a pioneer in innovative technologies for improving patients’ participation in clinical trials, has announced that its Enroll® and Engage™ technology infrastructure will support the ADAPTABLE (Aspirin Dosing: A...

Draft Guidance on Format of the Risk Management Plan (RMP) in the EU

by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, GVP, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research

Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices...

EU-US Privacy Shield

by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, Cybersecurity, Data Privacy, Digital Health Technology, Medical Apps, News, Virtual Clinical Research

Strasbourg, 2 February 2016 The European Commission and the United States have agreed on a new framework for transatlantic data flows: the EU-US Privacy Shield. Today, the College of Commissioners approved the political agreement reached and has mandated...

London Based Collaboration to Improve Access to Digital Health Market

by chuck_ltd | 16 Feb, 2016 | CHCUK News & Articles, Digital Health Technology, EHR, Virtual Clinical Research

An initiative launched on Wednesday, DigitalHealth.London, is aiming to accelerate the development, commercialisation and uptake of digital health technologies in the UK by improving access to the market for companies and entrepreneurs.  It is hoped that this will, in...

Switzerland: Online Ethics Committee Submissions Now Mandatory

by chuck_ltd | 26 Jan, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Registry, Virtual Clinical Research

Starting from January 1st 2016 the online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees is mandatory. Link: https://submissions.swissethics.ch/en/ No submissions or updates outside of BASEC...

New French Regulations put HCP-Industry Relationships in the Spotlight

by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research

On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”).  Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...

EU: Final Addendum I to GVP Module XVI on Educational Materials is Published

by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, Consultation, GVP, News, NIS, Real Word Evidence, Registry, Virtual Clinical Research

Latest EMA GVP (XVI) Module Update The final Addendum I to Module XVI on educational materials is published, taking into account comments from the public consultation. Further, revision 1 of Module XV on safety communication, with revision 1 of the template for Direct...

Human Rights Day: The Road Travelled Since 1948

by chuck_ltd | 14 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research

Human Rights Day – 10 October Herbert Smith Freehills LLP – Stéphane Brabant Beyond the traditional judicial fora where business enterprises can be challenged for human rights violations, they now also face ‘new judges’ such as NGOs, consumers, financial...

EU: CMS Conference Report – Implications of a Digital Single Market 2015

by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence, Virtual Clinical Research

On 16 October 2015, CMS hosted a conference on the implications of the European Commission’s plans to create a Digital Single Market. The conference generated meaningful discussions on the true impact, reality and consequences of the proposed framework. Key figures...

EU: New Agreement to Make EU Online Environment More Secure

by chuck_ltd | 8 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, Medical Apps, News, NIS, Real Word Evidence, Virtual Clinical Research

Commission Welcomes Agreement to Make EU Online Environment More Secure European Commission – Press release Brussels, 8 December 2015 Negotiators of the European Parliament, the Council and the Commission have agreed on the first EU-wide legislation on...

UK: MHRA's Position Statement and Guidance on Electronic Health Records

by chuck_ltd | 7 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

NHS trusts and health boards sponsoring a clinical trial, or hosting a trial sponsored by a commercial company need to ensure their electronic health record systems comply with legal requirements for good clinical practice. This guidance covers common inspection...

HealthCarePoint Unveils its Global BlueCloud™ Networking Technology

by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

Industry-changing technology will help break down healthcare and clinical research silos, empowering organizations to connect and share verifiable information in real time. Texas-based healthcare and clinical research networking-technology company HealthCarePoint...

Global: HealthCarePoint BlueCloud – Enhancing Collaborations Between Sponsors, HCPs and IRBs

by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

HealthCarePoint BlueCloud Enhances Collaborations Between Institutional Review Boards and Investigators to Help Site Sustainability HealthCarePoint (HCP) announces its collaboration with independent institutional review boards (IRBs). The announcement follows a...

Ireland: eHealth Ireland – The Future is Paperless!

by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

Background A national Electronic Health Record (EHR) has been identified by HSE National Directors and clinical leaders as a key capability requirement for the future delivery of healthcare. While technology solutions are a key component, there will be a primary focus...

Categories

  • 21 Century Cures Act
  • 3D Printers
  • AI
  • Biological Products
  • Biosamples
  • Biosimilars
  • Brexit
  • CHCUK News & Articles
  • CHCUK NIS Database
  • Consultation
  • Cures Act
  • Cybersecurity
  • Data Integrity
  • Data Privacy
  • Digital Health Technology
  • EAP
  • eConsent
  • EFPIA
  • EHR
  • eletronic Signatures
  • EMA
  • EU Clinical Trials Regulation
  • FDA 1572
  • FDA Guidance
  • FDAMA114
  • GCP
  • GCP Inspections
  • GDPR
  • Genetic Research
  • GVP
  • HIPAA
  • HTA
  • Human Tissue Research
  • Immunological Products
  • Informed Consent
  • Market Access
  • Medical Apps
  • Medical Devices
  • News
  • NIS
  • NIS Considerations Report
  • Orphan Drugs
  • PASS
  • Patient Centricity
  • Pragmatic Trials
  • Professional Standards
  • Promotion and Advertising
  • PROs
  • Publication Guidelines
  • Rare Diseases
  • Real Word Evidence
  • Real World Evidence
  • Real World Research Design
  • Registry
  • Regulatory Grade RWE
  • Regulatory Intelligence
  • Regulatory Science
  • Reimbursement
  • RWD
  • Safety Management
  • Sunshine Regulations
  • Transparency
  • Uncategorized
  • Virtual Clinical Research
  • Webinar
  • White Paper

News

May 2022
M T W T F S S
 1
2345678
9101112131415
16171819202122
23242526272829
3031  
« Feb    

Legal Information:

  • Terms & Conditions
  • Disclaimer
  • Privacy Notice

• CHCUK NIS Regulatory Database
• Contact CHCUK

  • Facebook
  • Twitter
Copyright © 2018 CHCUK. All Rights Reserved.

design by Poppy Design