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May 29, 2016

Interview with CluePoints on RbM
Dr. Peter Schiemann answers questions by CluePoints on Risk-based Monitoring

Peter Schiemann provided Widler & Schiemann’s position on the following topics:

  • When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring practices between companies and CROs of different size?
  • How are the regulatory authorities likely to respond to the widespread adoption of Risk-Based Monitoring - are they ready for it and why?
  • How do you think that the multitude of electronic systems is going to co-exist as Risk-Based Monitoring takes off? Will other systems become obsolete or will they need to evolve too?
  • Discuss the complexity of defining subjective thresholds using KRIs rather than (or in addition to) the objectivity of comparing one site against the others.
  • What are your thoughts on the ICH (E6) Addendum, how to implement the parts outlined in the guidelines practically for the respective area (EDC, Risk-Based Monitoring, etc.) and how the changes could impact current practices?

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New FDA draft guidance on EHRs
The FDA has just published their new draft guidance on “Use of Electronic Health Record Data in Clinical Investigations”

We have reviewed the new draft guidance and have summarized some take-home messages. We believe FDA has done a great job in creating a “one-stop-shop” for the agencies stance on EHRs. Please read our short analysis for further information.

In addition, we offer interested readers a more in-depth analysis on specific topics from the guidance. Please send us an inquiry at with the topic concerned included.

Read the pdf

News from EMA
New important publications by EMA on accessing information about medicines evaluated by EMA and Pharmacovigilance

A guide, released today by the European Medicines Agency (EMA), describes information the Agency publishes on centrally and non-centrally authorized medicines for human use.

Providing an overview of the range of documents produced by EMA during the life span of a medicine, the guide covers early development, through initial evaluation, adoption of positive or negative opinions, post-authorization changes and safety reviews.

Details of types of EMA documents, their publication times and where to find them on the EMA’s website are listed in an easy-reference annex.

Stakeholders will also find best-practice advice enabling coordinated, consistent and timely communication activities to ensure that information on medicines is accurate and reaches interested parties in the EU (European Union) on time

Read the pdf

The Committee adopted a draft reflection paper on non-spontaneous adverse event reports (EMA/CVMP/PhVWP/357539/2015) for a 3-month period of public consultation. The reflection paper outlines aspects of handling of adverse events reported in peer-reviewed literature and other non-spontaneous sources e.g. on the internet.

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Reform of EU Data Protection Rules
Both Directive and Regulation went into effect in May 2016

On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonized data protection framework across the EU. The European Parliament's Civil Liberties committee and the Permanent Representatives Committee (Coreper) of the Council then approved the agreements with very large majorities. The agreements were also welcomed by the European Council of 17-18 December as a major step forward in the implementation of the Digital Single Market Strategy.

On 8 April 2016 the Council adopted the Regulation and the Directive. And on 14 April 2016 the Regulation and the Directive were adopted by the European Parliament.

On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation entered into force on 24 May 2016, it shall apply from 25 May 2018. The Directive entered into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

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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 - -