Raquel Loreto
10 April 2025
Understanding US FDA Regulatory Affairs
6-hour
FDA overview, drug development regulations in US, INDs, FDA meetings, FDA review options available, NDA process, BLA process, ANDA process, 351K
Andrew Willis

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Issued to

Raquel Loreto

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Credential Verification

Issue date: April 10, 2025

ID: 1e2f6283-9db6-4240-92da-bf7442ce3d48

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. ,

Type

Course

Level

Professional

Format

Online

Duration

1 days

Price

Paid

Description

The holder of this certificate has attended the course "Understanding US FDA Regulatory Affairs".

This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.

Skills

Regulatory Affairs

US FDA

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.