CHCUK Newsletter Archives
Links to our non-interventional study newsletter (NIS Considerations) which you can access free of charge.

These newsletters have been created with the aim of keeping you informed of any key changes and updates to the regulations and guidelines applicable to the conduct of Non-Interventional Studies (NIS) and other Real World Evidence (RWE) Studies

If you require any further information or support please don't hestitate to contact me at or on +44 (0) 1997 42 33 11
  • NIS Considerations - August 2014
  • CHCUK: Why Wait for NIS News When You Can Get it Live?!.
    Article Headline
    EFPIA: Video Introducing the EFPIA Disclosure Code
    Austria: Pharmig Code of Practice Updated
    UK: NRES Website Closing Soon
    UK: Research Governance Framework to be Replaced
    UK: NHS REC Booking & Submission Changes
    EU: Revision 3 of the ENCePP Guide on Methodological Standard
    Ireland: The IMB is now the HPRA
    UK: Proposed Single Approval for Research in the NHS
    EU: EMA Releases Best Practice Guidance on Parallel Scientific Advice with HTAs
  • NIS Considerations - May 2014
  • CHCUK: Why Wait for NIS News When You Can Get it Live?!.
    EU: EMA Releases Guidance on Parallel Advice with HTAs
    EU: Revision 3 of EMA Guideline on Good Pharmacovigilance Practices (GVP): Annex I
    U: Revision 1 of EMA GVP Module XVI Published on 25 April 2014
    EU: Revision 1 of EMA GVP Module V Published on 25 April 2014
    U: Regulation Regarding Post-Authorisation Efficacy Studies
    CHCUK: 2014 Update to the NIS Considerations - Australia
    CHCUK: 2014 Update to NIS Considerations - France
    UK: MHRA Guidance on Medical Device Stand-Alone Software - Including Apps
    EU: EMA Launches Pilot Early Access Program
    EU: European Medicines Agency Publishes First Summary of a Risk-Management Plan
    Russia: New Requirements for HCOs who Conduct Clinical Trials
  • NIS Considerations - February 2014
  • CHCUK: New "NIS News & Articles" Webpage
    CHCUK: Why Wait for NIS News When You Can Get it Live?!.
    CHCUK: NIS Considerations (Europe - Part 2)...It's here at last!..
    New CHCUK NIS Promotional Video
    Romania: New ARPIM HCP/HCO Disclosure Code.
    Romania: ARPIM HCP Code Revised in Dec 2013
    Romania: New National Ethics Committee..
    Slovenia: Two New Codes of Practice Published in Dec 2013
    Croatia: Hundreds Charged with Corruption
    EMA: Draft Guideline on Key Aspects for the Use of Pharmacogenomic Methodologies
    EMA: Revision 2 of the Guideline on Good Pharmacovigilance Practices..
    France: Update on the 'French Sunshine Act'.
    Switzerland: Regulation Law on the Federal Act on Research Involving Human Subjects.
    Norway - LMI Rules for Marketing of Medicinal Products Revised in November 2013
    UK: ABPI Code of Practice for the Pharmaceutical Industry 2014
    UK: MHRA Good Pharmacovigilance Practice Compliance Report Template Now Available
    Finland: New Code for the Disclosure of Transfers of Value
    Estonia: APME Code of Ethics Revised
    Bulgaria: ARPharM Adopt Code for Disclosure of Transfers of Value by Pharmaceutical Companies to HCP
    Bulgaria - ARPharM Code of Ethics Amended in Nov 2013
    CHCUK: 2014 version of the Country-Specific NIS Report for Bulgaria Now Available.
    Germany: Federal Institute for Drugs and Medical Devices (BfArM) Launches New Website
    Germany - New BfArM/PEI NIS Guidance Coming Soon
    Germany: NIS Reporting Requirements in Germany - Are You Ready?
    India: New Audio-Visual Consent Guidelines
    Medicines Australia: Transparency Reporting
    Medicines Australia: HCP Consultant Reports to be Submitted by 30 April 2014
    Australia: Privacy Law Reforms Effective from 12 March 2014
  • NIS Considerations - November 2013
  • CHCUK: NIS Considerations (Europe)
    CHCUK: NIS Training - Try Before You Buy
    CHCUK: Late Stage Submissions Plan (LSSP).
    CHCUK Ltd: New Company Name
    EFPIA: New Code of Practice
    France: Disclosure of Agreements with and Advantages to Healthcare Professionals
    Poland: Belatedly Implements Directive 2010/84/EU
  • NIS Considerations - Septmber 2013
  • CHCUK: NIS Considerations (Europe)
    EMA: Revision of GVP Module VI.
    UK: MHRA Guidance on Non-Serious Reactions
    ISPOR: ePRO Validation Guidelines
    ISPOR: Pediatric PRO Instruments for Research to Support Medical Product Labeling
    FDA: Guidance on Risk-Based Approaches to Monitoring
    Ireland: Code of Practice 2013
    ENCePP: National Data Protection Requirements
    ENCePP: Second revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology
  • NIS Considerations - June 2013
  • CHCUK NIS Webinar 1: How do the Recent Changes to the EU PV Legislation Impact NIS?
    EMA: Revision of GVP Module VIII
    EU: Safety Reporting Requirements for NIS
    France: Disclosure of Agreements with and Advantages to Healthcare Professionals
    France: New Laws Impacting NIS Delayed to 2016
    WMA: Declaration of Helsinki 2013?
    Hungary: Approval Requirements for NIS
  • NIS Considerations - April 2013
  • EMA: New EU Pharmacovigilance Legislation - Key Concepts
    CHCUK: New NIS Webinar Series
    France: Transposition of the European Directive 2010/84/EU Regarding pharmacovigiance
    Greece: Simplification of Approvals and Contract Execution
    Italy: General Authorization to the Processing of Genetic Data
  • NIS Considerations - Feb 2013
  • New CHCUK Resource: NIS Considerations (Basics - 2013)
    EMA: New Guideline for NIS PASS Study Reports
  • NIS Considerations - Dec 2012 - Erratum
  • ERRATUM - Germany: New Notification Requirements for All Non-Interventional Studies
  • NIS Considerations - Dec 2012
  • Hungary: Overview of New NIS Regulatory Requirements
    Germany: New Notification Requirements for All Non-Interventional Studies
    Austria:...Updated Guidance for the Conduct of NIS
    Brookwood Academy:...Practical guide to post authorisation studies - requirements and concepts
  • NIS Considerations - Nov 2012
  • CHCUK: New Important Milestone
    CHCUK: NIS eLearning
    CHCUK: Country-Specific NIS Reports
    CHCUK: New Free NIS Resources.
    Europe: New EU PASS Protocol Guidance
    Europe: EU PAS Register
    Hungary: Reporting of Post-Authorisation ADRs
    Germany: New Requirements for Non-Interventional Safety Studies
    Spain: Updated Post-Authorisation Study (EPA) Q&A Document
  • NIS Considerations - Sept 2012
  • 2012 Edition of NIS Considerations (Europe): Part 1
    New NIS Considerations Reports
    New NIS eLearning Courses
  • NIS Considerations - June 2012
  • Italy: Use of Data without Consent
    Italy: 2012 Code of Ethics
    Greece: 2012 SFEE Code of Practice
    Belgium: 2012 Code
    Denmark - Danish Medicines Agency
    Denmark - New Data Privacy Rules
  • NIS Considerations - May 2012
  • CHCUK NIS eLearning Now Available
    Slovakia: 2012 COP
    France: 2012 LEEM Code of Ethics
  • NIS Considerations - April 2012
  • CHCUK NIS eLearning Now Available
    NIS eLearning - NIS Basics (Europe).
    France: New NIS Requirements
  • NIS Considerations - Feb 2012 (Suppl)
  • Sweden: 2012 LIF COP
  • NIS Considerations - Feb 2012
  • UK: 2012 ABPI COP
    EU: Introduction of New PV Legislation
    France: New NIS Requirements
    EU: GCP app for iPhone and Android
  • NIS Considerations - Dec 2011
  • Slovakia: New Clinical Trials Law
  • NIS Considerations - Oct 2011
  • Spain: AEMPS Website Updated
    Switzerland: Human Research Law
    Switzerland: NIS Approval Requirements
  • NIS Considerations - Aug 2011
  • Europe: EFPIA COP Updated
    UK: 2011 ABPI Code of Practice
    Norway: LMI Marketing Rules - 2011 Amendmentland 2011
    Norway: Translation of NIS Guidelines
    Slovenia: A Re-cap of the Requirements
    NIS Report (Part 2): 2nd Edition
  • NIS Considerations - June 2011
  • Denmark: Who do I Notify?
    NIS Considerations: Finland 2011
  • Considerations - Mar 2011
  • Czech Republic: Experience in NIS Data Collection
    Austria: Updated NIS Guidance
  • NIS Considerations - Jan 2011
  • France: Proposed NIS Regulations Loom Closer
    Latvia: Regulation 289 (2010)
    Spain: 2010 Code of Practice
    EMA & ENCePP Launch E-Register
    ICH: New Website
    Cyprus: Code of Practice
    Turkey: 2010 Code of Practice
    Switzerland: 2010 Code of Practice
    CHCUK: New NIS Training Slides
    Advertising Opportunity: NIS Report - Europe Part 2
    CHCUK: Bespoke NIS Reports
  • NIS Considerations - Oct/Nov 2010 (Supp 1)
  • Austria: New Reporting Requirements for NIS
  • NIS Considerations - Oct/Nov 2010
  • Latvia: New NIS Regulations
    Romania: Updated COP
    GRACE Principles
    UK: Proportionate Ethics Review
    Advertising Opportunity: NIS Report - Europe Part 2
    CHCUK NIS Regulatory Map

  • NIS Considerations - Aug/Sept 2010
  • NIS Report (Part 1): 2nd Edition
    Germany: 2010 Version of BfArM & PEI Recommendations for NIS Released
  • NIS Considerations - June/July 2010
  • NIS Report (Part 1): 2nd Edition
    Greece: 2010 SFEE Code of Practice
    Sweden: Updated LIF Code of Practice
    EC Pharmaceuticals Website Updated
    Austria: New NIS Ordinance
    Latvia: New NIS Regulation
    Norway: Updated Code of Practice
  • NIS Considerations - April/May 2010
  • NIS Report (Part 1): 2nd Edition
    NIS Report (Part 1): Advertising Opportunity
    UK: Data Protection Audits
    EFGCP Reports: 2010 Updates
    Turkey: New Guidance Document
    Germany: 2009 Update to the FSA Code of Conduct Published.
    Poland: INFARMA COP
    Switzerland: VKlin Amended
  • NIS Considerations - Mar 2010
  • Italy: Register of Obs Studies
    Seminar: Practical Guide to PAS
    NIS Resource: CIOMS Ethical Guidelines
    India: Ethical Considerations for NIS
  • NIS Considerations - Feb 2010
  • NIS Reports: Clarification
    Turkey: Obs Study Guidance
    Spain: Draft Guidelines Finalised
    Sweden: LIF COP Updated
    Switzerland: Unifying Human Research Law
  • NIS Considerations Jan 2010
  • NIS Report (Part II): Now Available
    Updates to the NIS Reports
    Free Clinical Research Resources
    Eudralex: New Address/New Format
    Your Input: News & Views
  • NIS Considerations Dec 2009
  • ENCepp Public Consultation
    Sweden: Change of Address
    Sweden: Broken Links
    Data Protection: Sweden
    Data Protection: Belgium
    NIS Report (Part II): Now Available
    NIS Considerations: UK
    Germany: AWB
  • NIS Considerations Nov 2009 (Amended)
  • Broken Links
    Data Protection
    Data Protection: Germany
    Data Protection: Portugal
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