Clinical Trials Europe 2019 - Barcelona, Spain
CCIB, Barcelona, Spain - Clinical Trials Europe - Tuesday 19 - Thursday 21 November 2019
Paul Bouten attended the Clinical Trials Europe Congress where he has chaired - STREAM 1 - "Partnerships and Outsourcing in Clinical Trials" - and moderated a panel discussion on day 2, November 20, 2019.
Day 2, November 20, 2019
STREAM: - Partnerships and Outsourcing in Clinical Trials -
PANEL: "How to approach CRO Oversight, RBM in light of ICH E6 R2"
- What does ICH E6 R2 means for risk-based monitoring?
- How is the industry approaching the ICH E6 R2 addendum changes: the struggles and challenges they faced or continue to face?
- What does a sponsor expect the CRO to handle on its behalf?
- How are sponsors and CROs collaborating to ensure clinical quality risk management?
- How are sponsors and CROs handling oversight, especially when CROs subcontract to third party vendors?
Pharmaceutical Contract Management Group (PCMG) Annual Conference 2019 - Sitges - Barcelona, Spain
05- 07 June 2019
Paul Bouten attended the PCMG Annual Conference 2019
Navigating the 7 Cs of Outsourcing & Procurement:
NVFG CLINOPSDAG 2019 - Ede, the Netherlands, 15 May 2019
Paul Bouten attended the NVFG ClinOpsDag 2019.
Titel: De research professional van alle markten thuis!
Title: The research professional all-rounder!
Agenda en thema
Het thema van deze 9de editie van de NVFG CLINOPSDAG staat in het teken van de hedendaagse research professional, die echt van alle markten thuis moet zijn!
Health Valley Event – Where people make the difference – Nijmegen, the Netherlands -14 March 2019
14 March 2019
Paul Bouten attended the Health Valley Event. The event centres the topic “CONCEPTS FOR A HEALTHY LIFE"
Innovation forHealth and Global Investor Forum -Shaping the future of healthcare-, Rotterdam, the Netherlands -14 February 2019
Paul Bouten attended the Innovation forHealth and Global Investor Forum conference and looking forward to learn more about “latest developments and trends in healthcare innovation”.
To meet companies and/or peers with a vision to set-up business differently in developing and marketing products
(considering: - Personalized Medicine, - AI, - Algorithm, - Wearables and develop quicker, leaner).
To discuss potential needs, how and where I can support your company with: - clinical research, - operations, - project management,
- procurement & outsourcing (Third parties (i.e. CRO,CLS)) and - regulatory (submissions CA, EC).
•NVFG - EMA Symposium - Amsterdam, the Netherlands - 5 February 2019
Paul Bouten attended the NVFG symposium.
- EMA IN NEDERLAND -
“Impact en nieuwe mogelijkheden!”
- EMA IN the NETHERLANDS -
"Impact and new opportunities!"
Partnerships in Clinical Trials (PCT) 2018 - Barcelona, Spain
CCIB, Barcelona, Spain - Tuesday 27 - Thursday 29 November 2018
Paul Bouten attended the Partnership Clinical Trials (PCT) Congress where he has
chaired STREAM 4 – "Governance, Quality, Oversight & Risk Management" –
and moderated a panel discussion on day 2, November 28, 2018.
Day 2, November 28, 2018
STREAM 4: - Governance, Quality, Oversight & Risk Management -
PANEL: "Optimising the Sponsor - CRO partnership: Quality oversight in outsourced clinical trials"
- What is meant by oversight - Do we mean the same if using oversight?
- Balance between micromanagement and oversight
- Developing and implementing the right tools parties involved in oversight (sponsor and CRO/third party) - How to label it as quality oversight?
- Makes RBM oversight easier
- What is the effect from RBM on Quality, Risk Management and how captured during oversight
- How much oversight is overkill?
- Governance and Oversight – the difference if any?