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Lightning Workshop: Supporting the Increased Demand for Global Data

Luis Jimenez  (Vice President of Business Development, Brandwood CKC)

Location: 210C

Date: Thursday, February 13

Time: 10:45 am - 12:15 pm

Vault Recording: TBD

Demonstrating clinical safety and effectiveness with clinical benefits for patients is an essential element not only to reach market approval but also to convince the medical community that a device is safe and contributes significantly to a patient’s wellbeing. Generating such data is an effort that takes many resources to complete and weighs heavy in the overall budget of manufacturers. More and more regulators are open to accept foreign data making it possible for many devices to conduct fewer clinical investigations by either including clinical centres from different geographic areas or use the data generated in one part of the world for registration in another.

Topics covered include:

  • An analysis of when globalization of clinical data is possible
  • Strategies to help you plan for the collection of global data
  • How the globalization of clinical data can increase speed-to-market and reduce overall the need for duplicating studies in different geographic areas
  • Discuss real-life case studies demonstrating success

Presentation File

Thurs_210C_1045am_Globalization_of_clinical_data__Luis_Jimenez_MDM.pdf