Regulatory Surveillance
UK
Benelux
Sweden
Denmark
Israel
Spain
France
Italy
Austria
Russia
Ukraine
Poland
USA
Regulatory Surveillance
Review of country drug, medical device & biotechnological trials legislation
Harrison Clinical Research established the need for updated clinical trials regulatory information with the focus on current regulatory requirements where HCR is responsible for obtaining EC approval and CA authorisation. We have developed a regulatory database with local experts around the world, via a coordinated network. The informations collected are, the required documents for EC/CA submission, country specific regulations and guidelines, and timelines for obtaining EC/CA approvals. Regulatory Surveillance Report data is collected by, local expert review of all relevant Web pages, compilation of all current information into a report and addition of the information into the HCR Regulatory Library.
The report, Regulatory Surveillance Report No: 6, that can be downloaded below, details all changes or additions to regulations, in the 37 countries detailed, since January 2011 and up until end April 2011. New reports will be issued approximately quarterly. Only changes since the last report are detailed, where there has been no change since the last report in a particular country, this is noted by the term "No change".
As a separate summary the new EU Guidance changes appertaining to - Detailed guidance on the request to the competent authority for authorisation of a clinical trial on a medicinal product for human use, the notification of a substantial amendment and the notification of the end of the trial - have been added as a separate document.
If you would like to download the report, please submit your contact data in the e-mail form below, once you have pressed the "send" button, you will be able to download the Regulatory Surveillance Report No: 6, free-of-charge as a pdf file. If you would like to send us feedback on the current report, please use the comments box in the e-mail form.
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Regulatory Surveillance Report
Download the complete report as a PDF file after completing the form below.
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Gold Award to
Harrison Clinical Research
Presentation to HCR, by Lloyd's Register Quality Assurance (LRQA) of the Gold Award for more than 10 years of certified compliance with ISO 9001 standards.