EMA CT Regulation and EU Portal

CT Quality in the Digital Health Era

Risk-based Monitoring and RBQM

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Fleming.'s logo
Austria Vienna
Location
September 13 - 14, 2018
Date range
From 1515 USD
Pricing
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Event details


Overview

The 3rd Annual Clinical Trials and Quality Compiance Conference covers a deep look inside the implementation and requirements for risk-based quality management 2 years after ICH E6 R2 Addendum release. This conference includes special features like Inspector's view, Round-table discussion, 5 hours of practical case studies, great speaker panel and the agenda created by senior executives in the Medical Devices and Diagnostics industry.

Rating

8.73 / 10
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Rate Clinical Trials Quality & Compliance Conference

Reviews

15
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Anna Piccolboni

Visitor

This is the third time I participate and it is always an interesting opportunity for learning and keeping updated in GCP news and specially on Inspectors expectations. Very good

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Julien Deflassieux

Visitor

The break down sessions were not very interesting, also asking the presenters to organize them was not ideal as they did not seem prepared. Tables should be mixed and names assigned to facilitate the interactions. People should be given 5 min after each "mixing" for example after breaks to reintroduce themselves during 5 mn (take it from the time of the breaks) - The goal before end of the 1st day, everyone should have a good idea of who is doing what in the audience. Not all presentations were insightful, mostly the ones that showed the tools / strategy used by others, when its too general then it remains at a "bar type" discussion. Would have been good to have more input from the audience, their challenges etc in order to exchange more. Some time was also too devoted about high level discussions such as the future in clinical research. Very low usage of the voting tool, its a shame - seems that the presenter do not know how to integrate them in their presentations yet.

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The presentations were very theoretical and high level. I was missing best practise sharing how to inplement in daily work and how to get investigatord on board.

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Working for a small CRO it was important for me to know and see where the big pharma and CRO's are and what experience they have with QA. It was very insightful. It was too cold, too strong climatisation.

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Chairing 1st not good/chaotic (summary not done?). Second day (Matt) much better. it's a pity that the inspector's expectation session was cancelled, I was really interested in that. recommendation: play music before meeting starts and during the breaks...

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veryƮteractive with interrsting topicd and well organized.

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Tool is easy to use and helps to reduce paper and waste

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Great opportunity to hear about current hot topics and how companies are addressing them

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This event helps me to stay up to date, to see visions and challenges. Thank you.

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Chairing 1st not good/chaotic (summary not done?). Second day (Matt) much better. it's a pity that the inspector's expectation session was cancelled, I was really interested in that. recommendation: play music before meeting starts and during the breaks...

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Changes to agenda, probably beyond control of the Fleming, but indicates the conference needs to work on its reputation. Presenters should think twice before canceling their presence. Provision of the presentations during the conference would appreciated. Good opportunity to network or meet with new people from different, less known, companies or familiar faces. Thanks for the opportunity to present.

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Speakers 13

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Heiner Gertzen

  • Sanofi
  • Head GxP Inspection & Audit Readiness
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Albrecht De Vries

  • Janssen R&D (J&J)
  • Global Quality & Compliance Head
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Matthew Jones

  • Boehringer Ingelheim
  • Formerly Head Global Auditing Strategy and Planning
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Alexander Hoenel

  • AGES
  • Former GCP Inspector
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Bodo Lutz

  • Novartis
  • Data Integrity and Clinical Risk Management
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Jean Yves Cotin

  • UCB
  • Head of Clinical QA EMEA
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Michael Barsch

  • Novartis
  • Head Global Clinical Development QA Biosimilars Program
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Kerstin Konig

  • Merckgroup
  • Head Research Development Quality
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Ludmila Kutakova

  • Axon Neuroscience
  • Clinical Operations Manager
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Norbert Dank

  • UCB
  • Clinical Risk Management
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Beat Widler

  • Roche
  • Formerly Global Head Clinical Quality
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Stefano Marini

  • EUCROF
  • Vice President
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Sophie Morin

  • Janssen R&D (J&J)
  • Director Quality Planning & Strategy

Media

Organiser

Fleming.

Fleming. connects people who know the answers, bring you the know-how you seek and the opportunities you desire. Go to event website »