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The RQA Quality Systems Workbook 13/11/2011

Posted by Shirley Hallam in Quality Management.
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Help is at hand for anyone embarking on developing a quality management system in research and development.

Over the last few months, the Research Quality Associate (RQA) Outreach Working Party has been developing this accessible and practical workbook. Download a copy here.

“A Quality System sets out the standards that you are working to, and how you are going to meet them. The system should define what people, actions and documents are going to be employed in order to carry out the work in a consistent manner, leaving evidence of what has happened. It may include manuals, handbooks, procedures, policies, records and templates. The terminology used is less important than the purpose and use of the documents. The fundamentals of a Quality System are the same regardless of what your work is. The same principles can be applied whether you are an academic research laboratory, a medical device manufacturer or a hospital clinical trials unit

“Understanding, interpreting and implementing a Quality System is a skill in its own right.

“The aim of this new Workbook is to provide tools and a practical approach to develop a Quality System that works for the user.

“The Workbook concentrates on the core, underlying principles of quality which are pivotal – explicitly or implicitly – to all quality management standards that impact on research and development.

“These principles are also fundamental to the conduct of efficient, reliable and credible scientific and clinical work and will help the user to design and implement a practical Quality System that works for their organisation to make it more productive and compliant.

“The workbook may also help users in the task of persuading others of the importance of such a system. It is aimed at the doers within the Outreach target audience who will either have been delegated the task or are volunteers who have seen the need for a Quality System.”  RQA OWP

The Work book is available to both RQA Members and non-members as a free download here.

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.

Save our Inboxes – the Email Charter 30/06/2011

Posted by Shirley Hallam in Uncategorized.
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A colleague sent me this fantastic Email Charter today. In the interests of efficiency, performance and time (all important contributors to quality) I cannot commend it highly enough.

Let’s all think more carefully before we hit Send!

 

The Immortal Life of Henrietta Lacks (HeLa) 01/04/2011

Posted by Shirley Hallam in Ethics.
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Henrietta Lacks was a black woman from Virginia who died in 1951 of cervical cancer at the age of 31.  A tissue sample of her tumour was taken and cultured in the laboratory of Johns Hopkins Hospital, where it became the original source of the immortal HeLa cell line. 

In “The Immortal Life of Henrietta Lacks”, science writer Rebecca Skloot has painstakingly researched both Henrietta’s life and the scientific discoveries arising from the development of the first immortal cell line.  Written without sentiment or sensationalism, the contrasts are stark: a multimillion dollar industry based on research at the frontiers of the scientific understanding of pathology and genetics, originating from a poor black tobacco farmer, whose family have remained in relative poverty.

The book raises important questions of ethics in research, informed consent, and ownership of samples and genetic code.  Although these topics are familiar territory, I found that reading the book made me consider them afresh, from the perspective of both research subject and scientist.  There are no easy answers, and just as HeLa cells continue to multiply, the story doesn’t have a neat ending.  But it is a timely reminder of the importance of communication and engagement between scientists and the public; and in this Rebecca Skloot is a great role model.

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

Looking for a GCP Auditor? 02/02/2011

Posted by Shirley Hallam in GCP audit.
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Shirley Hallam has extensive experience of investigational site audits throughout Europe in phases I-IV in a wide range of therapeutic areas including oncology, haematology, rheumatology, cardiovascular and diabetes. Vendor audits, data management, archive facility and clinical study reports also conducted. In 2010 she completed BARQA Practical Pharmacovigilance Audit training.

Contact HallamPharma@aol.com for further information.

BARQA Seminar: Quality Management in Academic and Non-Commercial Research 18/01/2011

Posted by Shirley Hallam in Uncategorized.
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BARQA’s (British Associate for Research Quality Assurance) Outreach Working Party is organising a one-day seminar aimed at researchers in the non-commercial and academic sector.

The seminar will take place in Birmingham on 2nd March, and topics include trends in inspection findings, Quality Management Systems, SOP and training record preparation. Shirley Hallam will present a session on Managing an Inspection – preparation, performance and follow-up. There will be an open forum for delegates to bring forward questions and discussion items. The focus will be on finding practical solutions to improve quality and compliance.

Further information and a booking form are available at the BARQA website.

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

Quality Assurance in Good Clinical Practice 27/12/2010

Posted by Shirley Hallam in Uncategorized.
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Welcome to the new website of Hallam Pharma Consulting.

We provide quality assurance services in GCP, assisting pharma companies and non-commercial sponsors to achieve clinical research outcomes in a timely and efficient manner.