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
Question and Answers on the Interplay between the Clinical Trials Regulation and GDPR

Question and Answers on the Interplay between the Clinical Trials Regulation and GDPR

by Syneos Health_1 | 25 Jun, 2019 | EU Clinical Trials Regulation, GDPR, Uncategorized

The European Commission Directorate General for Health has published a question and answer document that aims to explain the interplay between the Clinical Trials Regulation (EU) 536/2014 and the General Data Protection Regulation (EU) 2016/679. This document “will be...

EU: Publication of Clinical Trials Results

by chuck_ltd | 22 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News

Regulation 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (the “Regulation”) Introduction Traditionally, the results of clinical trials have not always been published. This is often due to an increased number of...

EU CTR: Implementation Time Frames – The Long Road Ahead

by chuck_ltd | 19 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News

 Delivery Time Frame for the EU Portal and EU Database October 2018 – Regulation (EU) No 536/2014 becomes applicable October 2021 – Directive on Clinical Trials 2001/20/EC no longer applicable These are planned timelines.  They have been set out to deliver...

EU: Overview of Comments on the “Functional Specifications for the EU portal and EU database to be Audited"

by chuck_ltd | 5 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials

Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014” Draft proposal for an addendum, on transparency, to the “Functional...

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

December 2023
M T W T F S S
 123
45678910
11121314151617
18192021222324
25262728293031
« Feb    

Legal Information:

  • Terms & Conditions
  • Disclaimer
  • Privacy Notice

• CHCUK NIS Regulatory Database
• Contact CHCUK

  • Facebook
  • X
Copyright © 2023 CHCUK. All Rights Reserved.

design by Poppy Design