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
Use of Patient Disease Registries for Regulatory Purposes

Use of Patient Disease Registries for Regulatory Purposes

by Syneos Health_1 | 19 Nov, 2018 | 21 Century Cures Act, CHCUK News & Articles, Consultation, Real Word Evidence, Registry, Regulatory Grade RWE

Use of patient disease registries for regulatory purposes (new) On 8 November 2018 the EMA cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes:...

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...

New FDA Guidance on Informed Consent Waiver for Clinical Investigations Involving No More than Minimal Risk

by chuck_ltd | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence

FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...

21st Century Cures Act— 11 February 2017 = Deadline for Company Disclosure of Expanded Access Programs

by chuck_ltd | 19 Jan, 2017 | CHCUK News & Articles, Cures Act, EAP, News

The landmark 21st Century Cures Act[1] (“Cures Act”), which was signed into law by President Obama and became effective on December 13, 2016 (“Enactment Date”), imposes a deadline by which the manufacturer or distributor of an investigational...

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

by chuck_ltd | 6 Jan, 2017 | Medical Devices

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types. This guidance generally affirms the framework...
« 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

July 2022
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
  • Twitter
Copyright © 2018 CHCUK. All Rights Reserved.

design by Poppy Design