Evelyn Neilan
03 April 2025
Regulatory Affairs for Combination Products (Drug/Device and Device/Drug)
12-hour
Defining a combination product in the EU and US, Development process, Understanding Medical Devices, Medical devices technical file, GMP / ISO standards, Medicinal regulatory submissions, NB opinion for drug/device, Key Considerations for regulatory strategy
Richard Young and Andrew Willis

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Issued to

Evelyn Neilan

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Credential Verification

Issue date: April 3, 2025

ID: 84f0e0b6-4094-4029-933f-913253f4ccd5

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Issued by

Educo Life Sciences

Educo Life Sciences is a learning and development specialist that provides technical training solutions to the pharmaceutical, biotechnology, cell and gene, and medical device industries. ,

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Type

Course

Level

Professional

Format

Hybrid

Duration

2 days

Price

Paid

Description

The holder of this certificate has attended the course "Regulatory Affairs for Combination Products (Drug/Device and Device/Drug)".

This combination product training course provides you with the skills and knowledge to navigate both the pharmaceutical and device regulations. You will examine the regulatory pathways for drug/device and device/drug products. You will examine small molecules, large molecules and ATMPs in combination with devices. Importantly, you will learn how to merge the two regulatory systems in areas such as risk management, quality and clinical.

Skills

Combination Products

Medical Device Development

Regulatory Affairs

CTD Submissions

Regulatory Strategy

Earning Criteria

Participation

Attended the live online or in-person course held by Educo Life Sciences.

Watching

Or watched the recorded materials for the course held by Educo.