Clients & Projects (NIS)

NIS eLearning Modules

April 2012 to present

CHCUK now offer non-interventional study eLearning packages for the following countries:CHCUK Global E-learning

  • Argentina
  • Austria
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Czech Republic
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Luxembourg
  • Mexico
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • The Netherlands
  • UK
  • USA

Each of the country-specific courses is narrated, includes comprehensive supporting documentation and generates a PDF certificate of completion.  The courses explore the Country-specific requirements when conducting non-interventional studies and look specifically at:

  • Regulatory classification

  • Regulatory framework/applicable legislation and guidelines

  • Approval requirements

  • Approval timeframes

  • Submission documents

  • Responsibilities

  • Practical considerations

  • Industry best practice

NIS Compliance Support for Enroll-HD

November 2010 to Present

CHCUK is providing advise on the laws and regulations that govern Non-interventional studies in Latin America and Europe and is providing expert guidance and support in 3 of the Enroll-HD working groups.

Link: CHDI Foundation – Enroll-HD

NIS Training – Investigator Meeting (Merck Serono)

November 2010 Merck Serono

CHCUK has created bespoke NIS training materials for Investigator Meetings for Merck Serono

Link: NIS Training Material

NIS Considerations Reports for Europe

August 2009 to Present

CHCUK has produced detailed reports that capture the country-specific regulations and guidelines applicable to non-interventional studies (NIS). These NIS reports have been developed as an aid for anyone responsible for managing and/or conducting non-interventional studies throughout Europe.

Non-Interventional Studies: Europe (Part 1)
– Part 1 covers the NIS regulations and guidelines applicable to the following countries: Belgium, France, Germany, Greece, Poland, Portugal, Spain, Sweden, Switzerland, The Czech Republic, The Netherlands

– Second Edition, September 2012

Non-Interventional Studies: Europe (Part 2)
– Part 2 covers the NIS regulations and guidelines applicable to the following countries: Austria, Bulgaria, Cyprus, Denmark, Estonia, Finland, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Romania, Slovakia, Slovenia, and the UK

– Second Edition, August 2011

Bespoke NIS Considerations Reports

CHCUK has produced bespoke reports to capture the NIS Regulatory considerations in the following regions:

  • Australia
  • Canada
  • Europe
  • Israel
  • North America
  • Russia
  • South Africa
  • South America

Clients include: Allergan, CHDI Foundation

Allergan CHDI