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

Revised Version of French Research Standard MR-003 Published

by chuck_ltd | 22 Aug, 2018 | CHCUK News & Articles, Data Privacy, Informed Consent, NIS

France – Health Research and Data Protection: Lawmakers Revise Research Standard MR-003 “Research in the Field of Health Without Collection of Consent” By Mark Heinemann, Principal Consultant, Real World Clinical Consulting, Syneos Health The French Data Protection...

German RECs Seek to Simplify NIS Approval

by chuck_ltd | 9 Apr, 2018 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Registry

Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies? Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting German Ethics Committees (ECs) make an important step towards the...

Non-Interventional Studies – What is the Biggest Challenge?

by chuck_ltd | 3 Nov, 2017 | CHCUK News & Articles, CHCUK NIS Database, News, NIS, NIS Considerations Report

Non-Interventional Studies… Q. What is the Biggest Challenge? A. Working out the regulatory requirements for your study! Finding out what’s needed to run a non-interventional study shouldn’t be difficult, but it is! We’ve taken the pain out of that process by...

Revision 2 of GVP Module VI Becomes Effective 22 Nov 2017

by chuck_ltd | 29 Aug, 2017 | CHCUK News & Articles, PASS

GVP Module VI, which deals with the collection, management and submission of reports of suspected adverse reactions to medicinal products has been amended. Revision 2  comes into effect on the 22 November 2017. Revision 2 boasts 144 pages versus the 90 pages of...

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...
« Older Entries

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