News

News

CCIB, Barcelona, Spain - Clinical Trials Europe - Tuesday 19 - Thursday 21 November 2019 

Paul Bouten will attend the Clinical Trials Europe Congress where he will moderate 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?

 

https://lifesciences.knect365.com/clinical-trials-europe/

 

https://lifesciences.knect365.com/clinical-trials-europe/speakers/paul-bouten-1#partnerships-and-outsourcing-in-clinical-trials-2_panel-how-to-approach-cro-oversight-rbm-in-light-of-ich-e6-r2

 

05- 07 June 2019

Paul Bouten will attend the PCMG Annual Conference 2019

 

Program

Navigating the 7 Cs of Outsourcing & Procurement: 

  1. Consistency

  2. Continuity

  3. Consolidation

  4. Collaboration 

  5. Change

  6. Complexity 

  7. Competency

 

 https://www.pcmg.org.uk/events/pcmg-annual-conference-2019-copy

Paul Bouten will attend the NVFG ClinOpsDag 2019. 

 

Titel: De research professional van alle markten thuis!

Translation:

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!

 

https://www.nvfg.nl/clinopsdag

14 March 2019

Paul Bouten attended the Health Valley Event. The event centres the topic “CONCEPTS FOR A HEALTHY LIFE"

 

http://www.healthvalleyevent.com

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). 

https://www.innovationforhealth.nl

Paul Bouten attended the NVFG symposium. 

Thema

- EMA IN NEDERLAND -

“Impact en nieuwe mogelijkheden!”

 
Translation:

- EMA IN the NETHERLANDS -

"Impact and new opportunities!"

https://www.nvfg.nl/activiteit/nvfg-ema-symposium/

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?

 

https://lifesciences.knect365.com/pct-europe/

https://lifesciences.knect365.com/pct-europe/agenda/2?stream=3#stream-4-governance-quality-oversight-risk-management_panel-optimising-the-sponsor-cro-partnership-quality-oversight-in-outsourced-clinical-trials