OC LIFe - International Clinical Trial Negotiation and Management

Going Global: Key Strategic and Legal Considerations you MUST know for Clinical Study Conduct outside the US.

Join our panel of U.S. and international regulatory and clinical trial experts who will cover:

  • Current Climate - Is OUS still your first, best, fastest option to market?
    • Devices/IVDs v. Pharma
  • The Case for Outsourcing
  • EU Legal Representation - Impact of EU v. UK requirement
  • Contracts, the Key to Compiance: contracts, GDPR/privacy laws, vendor management

Presenting Sponsor

Biocom_Logo_Horizontal-2

 

Biocom harnesses the collective power and experience of the most innovative and productive life science clusters in the world, with powerful advocacy and transformative programs to help companies in their quest to improve the human condition. Biocom provides the strongest public voice for research institutions and companies that fuel the California economy.


 

  

Event Speaker

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Myrthe Trompert

CEO, Salvius Legal B.V.

Founder and Chief Executive Officer of Salvius Legal B.V., has a Master's Degree in Law from the University of Amsterdam and has worked in the clinical trial industry for over 25 years. During those years, she has contributed in different strategic, management and business development roles, but in particular gained extensive experience in managing the contracting process for large multi-country studies and providing further customized legal support to the different parties in the clinical trial industry. Myrthe Trompert has worked for Contract Research Organizations such as Parexel, NDDO Oncology (later INC Research, now Syneos Health) and PharmaNet (later Inventiv Health Clinical, now Syneos Health). At PharmaNet, she held the position of Sr. Legal Counsel, responsible for the regions Europe, Latin- America and Asia. Since 2010, she is CEO of Salvius Legal and made it her mission to assist the different stakeholders in the clinical trial industry to make the contracting part of a clinical trial a manageable and controllable process, by applying efficiencies and creative solutions to improve timelines, while maintaining quality and consistency of the contracts involved.

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Allison Olivia, RAC

Principal, Comprehensive Clinical Consulting

Senior Clinical/Regulatory Consultant supporting medical device, biologics and pharmaceutical industries. Specialized in strategic planning, project management, clinical operations, study design and implementation, new product launch.

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Heike Schön

Shareholder and Managing Director, Lumis International

Heike Schön, has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post‑marketing activities in various indications. She had positions within the contract research organisations (CROs) and in the biotechnology industry. Her previous positions also included operational and general management. She holds a master’s degree in psychology and a master’s degree in business administration. Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.

Event Partners

SBDC_UCI_2019_Color_Logo-1024x329

The SBDC @ UCI Beall Applied Innovation is a resource for any high-technology, high-growth, scalable venture from both the Orange County and UCI ecosystem that needs assistance with business planning, business development and funding-readiness. The center hosts several VC and Angel investors on site, as well as various ecosystem partners and industry professionals who work closely with the entrepreneurs.

Meet with the Small Business Development Center (SBDC).

Whether you’re looking for guidance with starting your new tech venture, obtaining angel or venture capital, or looking for SBIR/STTR assistance, we're here for you!

Register Now

Event Details

Wednesday, July 28, 2021

9:00AM - 10:00AM

Join us for a virtual webinar!

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Upcoming Event

June 22, 2021
9:00AM - 10:00AM

Creating an Investable Startup: Executive Team & Advisory Boards - Part 3 of 4

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