CHCUK

August 2014
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In this Month's Issue
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
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NIS Country-specific eLearning

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Country-Specific NIS Reports
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Summary of NIS Requirements for Europe
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CHCUK: Free NIS Resources
 

The one thing we can guarantee in life is that things will change, especially when you're dealing with non-interventional studies.

I've included a snap shot of the recent changes and updates that are likely to have an impact on the conduct of your non-interventional studies, now and in the near future.


Best wishes,

Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: [email protected]
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CHCUK: Why Wait for NIS News When You Can Get it Live?!
 
NIS Considerations App

We've developed a new FREE app for all smartphone that provides you with live NIS news updates (from our updated website).

Just search for "NIS Considerations" on the applicable app store (iPhone, Android, Windows)


NIS Section News on our Website


We also h News ave a news section of our website which we regularly update.  The App feed directly from this, so if you don't want to keep visiting the website then just download the FREE app.
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EU: Clinical Trials Regultions

Change
Key Dates/ Facts

  • The EU Clinical Trials Regulation (Regulation EU/536/2014) was adopted of 16 April 2014
  • Entered into force on 16 June 2014
  • Will apply no earlier than 28 May 2016
  • Repeals EU Directive 2001/20/EC
  • May have an impact on the conduct of non-interventional studies due to the new definition of 'Low Intervention Clinical Trials'
Link:
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EFPIA: Video Introducing the EFPIA Disclosure Code


The Disclosure Code has been approved by the General Assembly on 24 June 2013. The final edited versions of the Code has been submitted to Compliance Committee comments, and has been reviewed by legal counsel.

Watch the EFPIA Disclosure Code Video

[Read More...]

 

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Austria: Pharmig Code of Practice Updated


The Pharmig Code of Ethics was updated 1 July 2014:
  • Ordinance 1/2014 stipulates new value limits for board and hospitality
  • Must be lower than EUR 75.00 per person and meal (including taxes and/or charges and tips)

 

read more...]  

 

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UK: NRES Website Closing Soon

NRES Logo
The website of the National Research Ethics Service (NRES) site will be closing in a few weeks. The only areas that are maintained are the directory of Research Ethics Committees and the Research Summaries.

The information previously found on the NRES website can now be found on the website of the Health Research Authority (HRA).  You will need to update your bookmarks and hyperlinks.
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UK: Research Governance Framework to be Replaced

The HRA is currently working on the development of a replacement for the Research Governance Framework. The HRA will consult on when they are established as a Non-Departmental Public Body (as part of the enacting of the Care Bill [2012]).

Research Governance Frameworks

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UK: NHS REC Booking & Submission Changes
NHS REC Booking & Submission Changes - Implemented 19 May 2014

The HRA has changed the processes for applying to Research Ethics Committees (RECs) to improve its service and make the booking and application process more straightforward for researchers.

[Read more...]

 

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EU: Revision 3 of the ENCePP Guide on Methodological Standard
EU: Revision 3 of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology Published (14 July 2014)

The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological ENCePPEnglish language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and key points from important guidelines, published articles and textbooks are highlighted. Where relevant, gaps in existing guidance are addressed with what ENCePP considers good practice.

[Read more...]
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Ireland: The IMB is now the HPRA  
Ireland - The Irish Medicines Board (IMB) is now the Health Products Regulatory Authority (HPRA)


On 1 July 2014, the Irish Medicines Board (IMB) changed its name to the Health Products Regulatory Authority (HPRA).

 

[Read more...

 

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UK: Proposed Single Approval for Research in the NHS


What is HRA Approval?

HRA Approval will provide a single approval for research in the NHS that will incorporate assessments by NHS staff employed by the HRA alongside the independent Research Ethics Committee opinion. This will allow decisions at local sites about participation to be made on local capacity and capability alone. The process will be coordinated with those in the devolved administrations and with other regulatory approvals to unify the approval process for research in the UK. HRA Approval will be available to NIHR portfolio studies and non-portfolio studies in England.

When Will it Happen?

Initially HRA will establish a programme team to plan and manage the process. Once these plans and timetables are agreed with relevant stakeholders, HRA Approval will be rolled out, on an application type basis. Roll out is anticipated to be completed by the end of 2015 and will be for all studies in England within a UK-wide coordinated framework.

 

[Read more...

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EU: EMA Releases Best Practice Guidance on Parallel Scientific Advice with Health-Technology-Assessment Bodies

EMA-LogoGuidance to facilitate early dialogue between regulators, health-technology-assessment bodies and medicines developers

The European Medicines Agency (EMA) has published today for public consultation best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies.

The draft guidance sets out the different phases of the process for EMA-HTA parallel scientific advice and highlights ideal timelines and actions for all parties, including HTA bodies, the EMA and applicants undertaking a parallel advice procedure.

The document has been drafted in collaboration with HTA bodies based on the experience gained so far with the EMA-HTA parallel scientific advice pilot project and on the input provided by stakeholders during the November workshop.

[Read more...]


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