Welcome to the 1st of our series of newsletters which aim to keep you up to speed with the regulations, guidelines and other news which may be relevant to you when managing and conducting non-interventional studies in Europe.
Feel free to contant me with suggestions and/or contributions to the newsletter.
The dynamic and ever-evolving nature of the jobs we do is
what adds to the excitement of our work.
It also means that websites, legislation and guidelines are always
changing and being updated which in turn results in broken hyperlinks.
We're very keen to ensure that you get the most optimal
tools for your work, so if you do come across any broken hyperlinks in the NIS
Report we would love to hear about them.
Please email us at firstname.lastname@example.org with the word 'Links' in the title and we'll fix the broken hyperlink.
Research Coordinating Committee for Post-Authorisation
A key impact of Royal Decree 1344/2007 of 11 October has been the mandate to create a
'Coordinating Committee for Post-Authorisation Studies' (the 'Committee'),
which was formed on the 24th September 2008 from
representatives of all of the Autonomous Communities and the Spanish Agency for
Medicines and Health Products (AEMPS).
On the 1st June 2009, the Committee published
their draft 'Guidelines on Post-Authorisation Studies of Drugs for Human Use' which have taken in
to account the terms presented in Chapter I.7 of Eudralex Volume 9A. This document is a draft
pending a public hearing prior to its publication as a Cabinet Order.
These comprehensive guidelines cover:
Background and Legal Basis
Scope of the Guidelines
Objectives of Post-Authorisation Studies
Identification Requirements for those Responsible
for the Studies and Key Elements to be Included in the Protocol
Administration Procedures for Post-Authorisation
Follow-Up of Post-Authorisation Studies
- Amendments to the Protocol
Follow-Up Reports and Final Reports
Notice of Suspected Adverse Reactions
Archiving of Study Documents
Interestingly, Section 8.5 of the guideline
introduces the element of inspections by the Health Authorities of the
Autonomous Communities to 'verify compliance with the statutory requirements
concerning post-authorisation studies (EPA) carried out in Spain'.
Part I of the NIS Report
, doesn't focus all that much on the data protection
element of managing NIS. However, due to
popular demand this important area will be addressed in Part II (due out in
December 09) and in the 2nd Edition of Part I of the NIS Report (due
out 3Q 2010).
In accordance with Article 15.02(e) of the 2007 EFPIA Code of Practice
(as implemented nationally): Local laws, rules and
regulation on personal data privacy (including the collection and use of
personal data) must be respected.
The implementation of the Data Protection Directive (95/46/EC
into national law means that the automated processing of sensitive data (such
as health data) needs to be notified to, or even authorised by, the relevant
national competent authority (Data Protection Agency).
Data Protection: Germany
2009 Update to the Federal Data Protection Act
Please note that the version of the German Federal Data Protection Act
(BDSG - as of 15th November 2006)
cited in Part I of the NIS Report is no longer valid. The Act was updated in July 2009 in response
to various data protection scandals which have recently hit the headlines. This recent amendment came in to force on 1st
September 2009. An English translation
of the updated Act is not yet available. However, the German version
can be found at the website of the Federal Commissioner for Data
Protection and Freedom of Information (BFDI
Data Protection: Portugal
For sponsors of NIS in
Portugal, attention is drawn to Articles 27 and 28 of the Act on the
Protection of Personal Data (Law 67/98 of 26 Oct) which define the requirements for the prior
notification to, and authorisation by, the Portuguese Data Protection Agency (Commissao Nacional de Protecção de Dados - CNPD) prior to
processing sensitive data. Refer also to
Articles 7.1 and 7.2.
Improved Check-Out Process
If you recently purchased Part I of the NIS Report you may be aware that a server 'glitch' meant some of you didn't receive your purchased publication. Please accept our apologies for the
We have updated the Shop checkout system to prevent a
re-occurrence. When you now purchase a PDF report you are prompted to download
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