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Oct 01, 2014

 
Good Clinical Practice: A Q&A Reference Guide 2014 – Beat Widler on advisory board
Over 1200 questions regarding the interpretation and implementation of GCP standards for drugs, biologics, and medical device clinical trials.

At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are "best practices" derived from regulations, guidances, and industry standards and practices and not all found in black and white in the regulations. Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continue to represent challenges for the pharmaceutical, biotechnology, and medical device industries.

More details online



NHS Health Research Authority issue Draft Guidance on Participant Information at the End of a Study
Historically researchers have not consistently provided the results of studies to participants, however participants increasingly expect findings to be made available to them at the end of study

The UK's NHS Health Research Authority (HRA) announced that they have developed draft guidance on how and what information should be supplied to participants (including children and their parents/carers) at the end of a study: Information for participants at the end of a study: Guidance for Researchers. It is aimed at those undertaking clinical trials and other interventional or diagnostic studies.

Read the pdf



MHRA leads innovative EU project on the use of smartphones and social media for drug safety information
The Medicines and Healthcare products Regulatory Agency (MHRA) is leading a consortium of organizations including European medicines regulators, academics and the pharmaceutical industry in a three-year project to develop new ways of gathering information on suspected adverse drug reactions (ADRs).

The project, known as WEB-RADR, is in response to the rapid adoption of smartphones, apps, and social media for discussing issues with medicines and health. It will work to develop a mobile app for healthcare professionals and the public to report suspected ADRs to national EU regulators. It will also investigate the potential for publicly available social media data for identifying potential drug safety issues. All social media data used within the project will be appropriately anonymized to protect data privacy.

More details online



Risk-based Monitoring and targeted SDV Training
Get to grips with key risk management concepts and methodologies to reduce trial costs

Widler & Schiemann Ltd lead a two day PTI training course in London on October 28th/29th on risk-based monitoring and targeted source data verification:

  • Understand the regulatory expectations to ensure compliance
  • Identify how risk management can be applied in study management and monitoring of clinical trials
  • Explore central possibilities of SDV in order to limit this task for the monitors on site
  • Define key risk indicators that aid decision making in monitoring and SDV

More details online



EudraLex V29 - September 2014
The new EudraLex V29 Search Engine is live

Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine The EudraLex V29 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection. For a non-commercial use, EudraLex V29 may be duplicated, shared and the documents may be printed.

More details online

 

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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - info@wsqms.com - http://www.wsqms.com