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EU Clinical Trials Regulation 11/06/2014

Posted by Shirley Hallam in Approvals, Regulatory.
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Slide21The European Union Clinical Trials Regulation 536/2014 was published in the official EU Journal on 27th May 2014.  It will enter into force on 16th June 2014, and will be implemented either from 28th May 2016, or six months after the necessary portal and databases become fully functional, whichever is the later.

The latest version of the GCP Update course offered by Hallam Pharma Consulting is now available, and includes a detailed overview of the Regulation.  Central to the new Regulation is an effort to simplify the submission and notification.  The illustration from the course materials illustrates the submission and approval timelines for part 1 of the application process.

For further details of this and other training courses please contact Shirley Hallam.

ABPI Phase I Guidelines 2012 Edition 05/09/2012

Posted by Shirley Hallam in Essential Documents, Regulatory.
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The Association of the British Pharmaceutical Industry has published new Guidelines for Phase I Clinical Trials, 2012 edition. At 63 pages, this is an informative and well written document, providing  not only a comprehensive overview of current requirements for phase I trials, but also historical background on the development of clinical research legislation in the UK. The introductory sections would make a good starting point for anyone interested in learning more about the drug development process.

On the whole the guidelines are derivative, referencing UK and European legislative requirements and guidance, and other recently published research. As might be expected post TGN1412 there are detailed sections on Risk Assessment (section 4) and Risk Management (section 5) in phase I research.

Section 8 Contracts goes beyond the definitions of essential documents in ICH E6, including the IMP dossier and CT application among the list if documents which must be supplied by the sponsor to the investigator before the trial begins.

There is clarification in section 9 that general (i.e. non study specific) recruitment advertising and non-invasive screening procedures do not require REC or MHRA approval. There is reference to the TOPS database for the prevention of over-exposure.  There are several mentions of the importance of communicating with the subject’s General Practitioner.  Subject payments should be based on the minimum hourly wage and should be increased for procedures requiring extra care on the part of the subject or involving more discomfort; however, payment must never be related to risk. There is guidance relating to payment for cancelled or prematurely terminated trials.

Phase I units should have a designated pharmacy area, carrying a stock of treatments for common adverse events and an antidote to the IMP, if one exists.

Particularly welcome in the guidelines is the specificity with regard to qualifications which key researchers might be expected to have – a concrete answer to the question “What is appropriate?” in the context of the much quoted ICH E6 principle that those conducting clinical research should be “appropriately qualified by education and experience”.  So Appendix 1 includes a list of possible post-graduate qualifications for medical researchers, while section 21 suggests that laboratory heads would be expected to have “a professional qualification such as FIBMS”

Red Tape Challenge – do we need so many regulations? 19/08/2011

Posted by Shirley Hallam in Regulatory.
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The UK government announced that it was going to review unnecessary legislation when it came to power in 2010.  In April 2011 the Red Tape Challenge website went live, inviting the public to comment on any areas where there were over burdensome or obsolete regulations.

 Because there have been many comments from businesses about enforcement, the consultation has now been extended to include Regulatory Enforcement.  The theme will run to mid-September. 

 Feedback is invited on the following:

  • How enforcement has placed an unnecessary burden on you or your business
  • Whether you have experienced overlap between different enforcement rganisations? If so how?
  • Your experiences of particularly overzealous enforcement that is beyond the remit of the regulation
  • Where you feel that you or your sector could manage compliance without intervention by enforcers
  • Where enforcement works well and is helpful.

 The MHRA has posted a link to the Red Tape Challenge website, and clearly is expecting to come within the scope of the review.

 Do you have thoughts on pharmaceutical legislation or the way in which is enforced by the MHRA?  Now is your chance to make them known: Red Tape Challenge website.

Revision of the Clinical Trials Directive 2001/20/EC 28/02/2011

Posted by Shirley Hallam in Approvals, Regulatory.
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Following last year’s public consultation exercise to assess the functioning of the Clinical Trials Directive 2001/20/EC, the European Commission has issued a concept paper to assess the impact of proposed legislative changes.  The concept paper sets out a preliminary overview of potential changes to the directive, and invites responses on 18 specific consultation items.  Responses should be forwarded to the Commission by 13 May 2011 at the latest. 

The concept paper can be found at: http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf

New Pathway for the Regulation and Governance of Health Research 11/01/2011

Posted by Shirley Hallam in Approvals, Regulatory.
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The Academy for Medical Sciences, chaired by Prof Michael Rawlins, has unveiled its recommendations for a streamlining the systems of approvals and governance for health research, including clinical trials. The main suggestion is the creation of a new Health Research Agency to rationalise the approvals required to conduct research.

The introduction of the report criticises the current barriers to research, specifically:

  • Delays and duplication in obtaining research permissions from NHS Trusts.
  • Complexity and inconsistency across the regulation pathway.
  • A lack of proportionality in the regulation of clinical trials.
  • Inappropriate constraints on access to patient data.
  • A healthcare culture that fails to fully support the value and benefits of health research.

The new Health Research Agency should have two major functions:

  • A National Research Governance Service that would eliminate inefficiency and support NHS Trusts and researchers by undertaking all NHS research governance checks just once.
  • A single system for ethical approvals. This system would encompass the responsibilities for both general ethical approval (the National Research Ethics Service), as well as specialist approvals and licenses

The report also calls for:

  • A reduction in the scope of the European Clinical Trials Directive, with risk based monitoring and a simplification of the requirements for drug safety reporting.
  • Greater access to patient data for research purposes.
  • The embedding of health research to be embedded into NHS leadership and governance processes, ensuring that within each Trust there is an executive director with specific responsibilities to promote health research.

Full Report: http://www.acmedsci.ac.uk/index.php?pid=47&prid=88