june 2017 europe’s switch to new ich gcp, eudravigilance...
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June 2017 – Europe’s Switch to New ICH GCP, EudraVigilance & Brexit
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Awarded to PPH plus
05/2016
ICH GCP E6(R2) Embraced in Europe
The new ICH GCP E6(R2) guideline will be effective from 14 June 2017 in Europe. It resembles the many contemporary
requests placed by regulatory authorities, ethics committees, pharmaceutical representatives, auditors and inspectors,
filling a gap of over two decades of desynchronization between current best practice and the ICH GCP guideline of 1996.
The PPH plus team has created a checklist to evaluate the operational readiness for the imminent ICH GCP E6(R2)
effective date. We are pleased to provide you with a handy readiness questionnaire (three-fold brochure), with concrete
questions concerning all addenda to current ICH GCP. PPH plus expanded the contents in an exhaustive ICH GCP
E6(R2) Readiness Checklist, containing additional practical recommendations, which will be made available upon
request.
Do you need support with the ICH GCP E6(R2) implementation? The PPH plus Senior Project Leaders will be pleased to
support you with quality planning and holistic clinical study management services.
Forthcoming EMA Guidelines on TMF & Serious Regulatory Breaches
The new EMA’s guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content,
management, archiving, audit and inspection of clinical trials is open for consultation until 11 July 2017). The new TMF
guideline is harmonized with and enhances the updated ICH GCP E6(R2) requirements concerning essential documents.
A new guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol is
publicly available for a 3-month consultation period which started on 23 May 2017. According to the current guideline,
reporting to the European regulatory authorities will be intensified concerning serious regulatory breaches and protocol
deviations that potentially have a critical impact on human subject protection or data integrity, including deviations
observed in non-EU regions.
Green Light to the New EudraVigilance System
Marketing authorization holders will soon no longer have to provide suspected unexpected serious adverse reaction
(SUSAR) reports to national competent authorities. A simplified SUSAR reporting method will reduce duplication of
efforts with a direct report to the new EudraVigilance system. The improved version of the EudraVigilance system will go
live on 22 November 2017. The official announcement and confirmation of full functionality of the EudraVigilance
database (22 May 2017) is available here.
Users of the EudraVigilance system need to ensure that their processes and IT infrastructure are compatible with the
new system and the internationally agreed format before the above-mentioned launch date. EMA offers a hands-on
training course on the new system functionality to learn how to create, send and access ICSRs in the new ISO/ICH
E2B(R3) format (see training course details here).
Regulatory Guidance on Brexit
Regulatory guidance (questions-and-answers document) for industry to prepare for the UK’s withdrawal from the EU has
been published by the EMA on 31 May 2017 (see announcement here). The Q & A document is clarifying primary
regulatory requirements for companies with headquarters or facilities operating in the EU out of the United Kingdom
(UK).
Additionally, the EMA has created a dedicated webpage on the consequences of the Brexit that should be checked
regularly for essential regulatory preparedness updates.
CONTACT
Dr. María Proupín-Pérez,
PMP
Senior Project Leader
Phone +49 (0)69 587 00 35 24
Dr. Matthias Fehlinger,
PMP
Senior Project Leader
matthias.fehlinger@pph-
plus.com
Phone +49 (0)69 587 00 35 30
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