Jonathan Hughes

Jonathan Hughes, Ph.D., FTOPRA, has over 35 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.

Jonathan has hands-on experience in a variety of therapeutic areas and has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, in-vitro diagnostics, software controlled devices and standalone software (including mobile apps). He has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.

  • Next: 18-19 Jun 2024 Live online
  • Also: 10-11 Sep 2024 Classroom
  • Also: 2-3 Dec 2024 Live online

FDA Approval Process for Medical Devices

Live online, Classroom

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours Focused
  • Presented by Dr Jonathan Hughes
  • Next: 17-18 Sep 2024 Live online
  • Also: 21-22 Jan 2025 Live online
  • Also: 19-20 May 2025 Live online
  • Also: 10-11 Sep 2025 Live online

Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

Live online

Practical guidance complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

  • 12 CPD hours Focused
  • Presented by Dr Jonathan Hughes