Breakout Session II

Breakout Session Options:

  • Operationalizing Decentralized Trials
  • Placebo or Nocebo: How to Ensure Your Trial Data is Pure
  • Building an All-Star Oncology Research Team
  • Site Impact of the New European Regulation 536/2014
  • The Importance of Diverse Clinical Trial Enrollment in the EU

 


Operationalizing Decentralized Trials
It doesn’t have to be this hard! Learn how to set up and execute your study visit effectively. This session will provide the flowchart that makes a study participant’s visit less burdensome and improve the experience for the study participant and staff.

Facilitator
Chiara Cassaniga, MS,
Sr. Director, Site Strategy and Relationship Lead, PPD, part of Thermo Fisher Scientific, Italy

Panelists
Ana Herradon, MS, Associate Director, Monitoring Manager, BMS, Spain
Janusz Kabata, MD,PhD, MBA,
CEO, GP4 Research, Poland

 


Placebo or Nocebo: How to Ensure Your Trial Data is Pure
The “placebo effect” is real, but how can you ensure your staff is not contributing to unpure data? Learn how to train your staff to avoid the placebo effect.

Facilitator
Dawie Wessels, MD, MBA,
Chief Medical Officer, Signant Health, UK

Panelists
Kaye Doiron, Founder & CEO, Research Works, Inc., USA
James Riddle, VP, Research Services & Strategic Consulting, Advarra, USA
Steve Satek, MBA, CCO, Flourish Research, USA
Michaela Vancova, Managing Director, Clinical Research Center, Slovakia

 


Building an All-Star Oncology Research Team
Success in clinical trials requires a strong and effective team that can conduct high-quality work. Break into the therapeutic area of oncology by building an all-star research team. Participate in a panel discussion to uncover the key qualities possessed by successful research staff and learn how to effectively train them for success.

Panelists
Malgorzata Gerjatowicz-Osmanska, MD, MBA, Regional Clinical Research Director, Pratia SA, Poland
David Rosenbaum
, MSc, Managing Director, Rosenbaum Group, Turkey

 


Site Impact of the New European Regulation 536/2014
Bracing for impact! This session will give you new insights on how the new Regulation 536/2014 affects you and your site. Join the experts as they share what changes have meant for them and lessons learned.

Facilitator
Carme Esteve,
EU Clinical Trial Submission Strategy Manager, Sanofi, Spain

Panelists
Carla Gomes, PharmD, MBA,
Director of Regulatory Affairs, PPD, part of Thermo Fisher Scientific, Portugal
Chris Watson, PhD, Director, Consulting, THREAD Research, UK

                                                                                                                                


The Importance of Diverse Clinical Trial Enrollment in the EU
The importance of diverse enrollment is understood and currently being actioned within the United States. However, as diversity is relevant to every country in which we conduct clinical trials, this topic is important throughout the world and will continue to grow in importance. This session will explore regulations set forth in other countries regarding diverse enrollment in clinical trials.

Facilitator
Diana Foster, PhD,
Vice President, Diversity, Equity & Inclusion, SCRS, USA

Panelist
Hans Christian Hoeck, MD, PhD, CEO, Trialcare Research, Switzerland
Dan Milam, EMBA,
Director, Clinical Trials Partnerships,  EQRx, USA

 

 

 

Location: See App for Room Location Date: 14 November 2022 Time: 15:30 - 16:30
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