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Jul 31, 2017

New USFDA Draft Guideline on Electronic Records and Signatures
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers

The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products. The draft guidance clarifies, updates, and expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812. Thus, the guidance is limited to the scope and application of part 11 requirements to such clinical investigations.

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Update of the BIMO Guidance Manual
USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff

FDA’s Compliance Program consists of several separate parts. “7348.810-Bioresearch Monitoring” is one of them. On the cover page, it shows an “Implementation Date” of April 19, 2017, however under “REVISION”, there is no date mentioned. It only says “COMPLETION DATE – Continuing”. For those of you who thought this is a new document; it is not. It has been around for a long time and has been updated regularly, the last update being the April 2017 version that constitutes a major revision.

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USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details

Today the FDA took two important new steps to encourage generic drug development and increase generic drug access:

These actions are part of Commissioner Gottlieb’s recently announced Drug Competition Action Plan, and follow the announcement of next month’s public meeting on administering the Hatch-Waxman Amendments. The agency plans to take additional, related actions in the near future, and will continue to communicate with stakeholders as these new elements are implemented.

EMA and EUnetHTA step up interaction to align data requirements
A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements.

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EMA: Revised Guideline for Entry into Human
Guidance outlines strategies to identify and mitigate risks for trial participants

The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants.

The revision takes into account the fact that in the past 10 years trial protocols have become increasingly complex and now often include different parts within a single clinical trial protocol, aimed at assessing for example single and multiple ascending doses, food interactions, or different age groups.

The revision considered the comments received during a public consultation and a follow-up workshop that took place in March 2017.

EMA will make available all comments received, both on the initial concept paper and on the revised guideline, in September 2017.

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New ICH E19 Guideline in development on Optimisation of Safety Data Collection
Guidance on targeted approach to safety data collection

In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.

The E19 Concept Paper and Business Plan are now available for download on the ICH website under the Efficacy section of the ICH website.

Read the pdf


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