Category Archives: Regulations

Ensure Your Informed Consent Forms Comply With New Requirements

Posted on February 10, 2012 by

For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to … Continue reading →

Posted in Compliance, Regulations | Leave a comment

GMP Directive (2003/94/EC) to cover active substances?

Posted on January 24, 2012 by

The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of … Continue reading →

Posted in Compliance, GMP, Regulations | Leave a comment

Is it OK to “manipulate” PDFs to improve records management?

Posted on January 23, 2012 by

This is a question that I hear posed fairly frequently, I guess as a result of organisations managing electronic records rather than – or in addition to – traditional paper records. A typical scenario is an electronic document received into the … Continue reading →

Posted in Compliance, e-records, Litigation, Records management practice, Regulations | 1 Comment

Certification by a qualified person and batch release – Consultation

Posted on January 5, 2012 by

A concept paper on revising Annex 16 of the guide to good manufacturing practice: certification by a QP and batch release is currently open for consultation until 31/01/2012 using the following link to the EMA website: http://bit.ly/yTocBW The concept paper … Continue reading →

Posted in Regulations | Tagged , , , , | Leave a comment

MHRA Opens Public Consultation on Review of UK Medicines Legislation

Posted on November 24, 2011 by

On 25th October, the MHRA opened a consultation period of 12 weeks for their review and consolidation of UK legislation pertinent to manufacture and use of medicines. Many requirements relating to the creation, management and retention of medical records are … Continue reading →

Posted in Regulations, TMF | Leave a comment

Documentation Risk Adaptations in Clinical Trials

Posted on October 30, 2011 by

A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of … Continue reading →

Posted in Compliance, Records management practice, Regulations, TMF | Leave a comment

Financial Disclosure to FDA – New Draft Guidance Available

Posted on May 25, 2011 by

Yesterday, 24 May 2011, the Food & Drug Administration (FDA) released for public review and comment a draft revision of the guidance for financial disclosure by clinical investigators. This will replace the last guidance issued back in 2001. The revised … Continue reading →

Posted in Regulations, TMF | Leave a comment

Beware sending spam emails!

Posted on May 6, 2011 by

The UK Information Commissioner’s Office (ICO) will shortly get increased powers to levy fines against companies that breach the rules regarding sending of unwanted emails (spam). The increased financial penalties – up to £500,000 – come into force as part … Continue reading →

Posted in Regulations | Leave a comment