OC LIFe - International Clinical Trials Negotiation and Management

Key Strategic and Legal Considerations for International Clinical Study Conduct

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

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

Create connections that could last a lifetime.

The OC LIFe (Life Science Innovators Forum) is a monthly free event series focused on creating a collaborative environment that fosters connections between innovators in the life sciences and medtech industry.


Presenting Sponsor

Biocom California Logo

 

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 Speakers

allison olivia-1

Allison Oliva, 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.

Heike-Schoen-Lumis-International

Heike Schön

Managing Director & Co-Founder, 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.

Kasia Kurowska headshot

Kasia Kurowska

Marketing & Business Development Specialist, Salvius Legal

An accomplished Marketing and Business Development Specialist with established track record of relationship building, marketing, and business development. Driven by a passion to provide a superior and creative customer experience. Excellent communicator with strong work ethic and experience in multi-national environments with the flexibility to work in various types of organizations. Skilled at business development, strategic planning, branding, budgeting and pricing estimation with focus on providing the highest quality service.

MYRTHE

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.

Event Partner

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!

Register Now

Upcoming Event

October 6, 2021
6:00PM - 8:00PM

MedTech Minds

Register Now

Apply for residency today

Do you have a great company in the bioscience or medtech industry? Do you need wet-lab and/or fabrication space to develop and test your product?

Apply

Other Events

October 6, 2021
6:00PM - 8:00PM

MedTech Minds

Register Now
October 13, 2021
12:00PM - 1:00PM

Healthcare Innovation: Financial Projections & Investor Perspectives - Part 9 of 10

Register Now
October 14, 2021
12:00pm - 1:00pm

A Bakery and a Medical Device Quality System

Register Now