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Jonathan Hughes

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Jonathan Hughes, Ph.D., FTOPRA, has over 32 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.

FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

22-23 Jun 2022

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.

FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

12-13 Sep 2022

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.

Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

29-30 Sep 2022

Practical guidance on borderline Issues and combination products

FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

5-6 Dec 2022

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.

Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

14-15 Dec 2022

Practical guidance on borderline Issues and combination products