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
EN
Issued to
Evelyn Neilan
Want to report a typo or a mistake?
Credential Verification
Issue date: April 3, 2025
ID: 84f0e0b6-4094-4029-933f-913253f4ccd5
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.