Welcome to the first of our 'NIS Considerations' newsletters of 2010.
We hope that this newsletter finds you well and wish you a happy, peaceful and productive New Year.
We've decided to make this a 'lite' newsletter so that we can all catch our breath before we race into another new and exciting year. So expect a more comprehensive newsletter next month.
NIS Report (Part II)
Part 2 of the NIS Report is Now Available
You'll be pleased to know that Part II of the NIS Report is now available.
The report continues on from Part I and summarises the considerations for conducting and managing non-interventional studies in a further 17 countries:
Austria, Bulgaria, Cyprus, Denmark, Estonia, Finland, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Norway, Romania, Slovakia, Slovenia and the UK.
The report covers information such as Regulatory Bodies (Competent Authority, Ethics Committee(s), Data Protection Agency), Self-Regulatory Bodies (e.g., ABPI) and applicable codes of practice, guidelines and regulations.
More focus has been plcaed on the data protection element in this report.
Updates to the NIS Reports
We Plan to Update the NIS Reports in Nov 2010
We plan to update both of the NIS Reports on an annual basis which will include:
Everyone who has previously purchased a copy of these reports will recieve a complimentary copy of the updated reports
- Capturing new information such as updates to regulations and guidelines
- Updating the country-specific hyperlinks
- Producing a more comprehensive introduction which will include references to the relevant CIOMs, WHO and IPSE reports
Free Clinical Research Resources
CHCUK have Produced some Complimentary Clinical Research Resources Which May be of Interest
CHCUK have recently produced some complimentary clinical research resources which are available to download from our website.
The 'informed consent' report is of direct relevance to non-interventional studies, whereas the other 2 reports are not directly relevant but may still be of interest to you.
We are also currently producing detailed reports on the informed consent considerations for Europe which follow the idea of the 'NIS Reports' but are much more detailed. Please note that we do charge for this service. If you are interested please do contact us for further details at email@example.com or call us at +44 (0) 1997 42 33 11.
Eudralex: New Address/ New Format
The Web Address for Eudralex Has Changed
The web address for the Eudralex website has recently changed. There is no need to worry if you are using the old address as you will be automatically re-directed to the website and/or documents contained within it.
For those who want to update their bookmarks, the new address for the Eudralex Website is: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm
Eudralex Volume 9A
Also, the new Address for Eudralex Volume 9A is: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf
Your Input: News & Views
Please Feel Free to Submit Any News Articles
We'd like to make this free newsletter as informative and helpful as possible and would welcome short contributions from you. You will obviously be acknowledged as the author of the contribution.
Please submit your news articles to: firstname.lastname@example.org