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Sep 1, 2017

Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA

The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators.

The EU and the US have had confidentiality arrangements in place since 2003, allowing for the exchange of confidential information as part of their regulatory and scientific processes. However, complete exchange of information was not possible under these arrangements.

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The legislation for clinical trials has seen significant changes during the last decade, starting with the implementation, in 2004, of the Clinical Trials Directive 2001/20/EC (‘Directive’), continuing with the publication of the Good Clinical Practice Directive 2005/28/ECi in 2005 and more recently with the Clinical Trials Regulation (EU) No. 536/2014 (‘Regulation’).

Despite the relative flexibility of the legislation and guidelines (for e.g. ICH Guideline E6(R2) for Good Clinical Practice), it has been observed that in general a ‘one size fits all’ approach to the design and conduct of clinical trials has been followed to comply with the ethical and scientific standards of Good Clinical Practice (GCP). Some clinical trials, however, pose only a minimal additional risk to subject safety and/or trial integrity compared to normal clinical practice.

A proportionate approach to the design and conduct of clinical trials is therefore supported by the Regulation. This approach should be adapted to the risk to the subject and/or trial integrity of the research carried out, as well as to the risk related to the reliability of trial results.

This document presents a factual summary of the responses to the public consultation:

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EMA prepares for Brexit
Business continuity plan aims to preserve Agency’s ability to protect public and animal health

The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation.

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EMA Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: pediatric population
New Guideline open for comments until 13th October 2017

Adverse reactions in the pediatric population need a specific evaluation, as they may substantially differ - in terms of frequency, nature, severity and presentation - from those occurring in the adult population. The importance of performing specific research in pharmacovigilance targeting the pediatric population has been recognized and established, and modalities of data collection should take into account that medicines in the pediatric population have a different utilization pattern and often are used off-label.

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The new 2017 Good Clinical Practice Q&A Guide is available!
Dr. Beat Widler is a reappearing author for this guide and member of the editorial board

This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2017 guide includes:

  • Updates focused specifically on the revision of ICH GCP (E6 R2) and the impact on clinical trial processes and systems.
  • Over 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, TMF, Data Management and many other core GCP areas.
  • Dozens of new Q&As, including in-depth analysis from distinguished international GCP expectations, including risk-based monitoring, electronic informed consents, eSource, TMF readiness and others.
  • Newly added chapters on clinical data management and the TMF.
  • Completely updated sections featuring all the latest data and trends on the FDA and EMA’s clinical trial compliance inspections, inspectional
  • Findings, and common areas of GCP noncompliance.
  • Updates to reflect the very latest FDA guidances, regulations, comments, and developments for both drugs and devices.
  • Updates to information on Australia, Canada, China, India, Israel, Latin America, New Zealand, and Russia.
  • Insights into FDA’s focus on sponsors’ quality systems and risk-based approaches, especially when GCP compliance issues are discovered at the clinical study site.

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Dr. Oliver Hellstern invited as lecturer for Pharmacovigilance at ETH Zurich
Our PV Practice Leader, Dr. Oliver Hellstern, to teach about Pharmacovigilance at the University ETH Zurich

As external lecturer for the new MSc in Pharmaceutical Sciences Program at ETH Zurich, our colleague and Pharmacovigilance Practice Leader, Dr. Oliver Hellstern, has been invited by the Institute of Pharmaceutical Sciences to support their program as Pharmacovigilance Expert.

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