US Drug and Biologics Regulatory Pathways Professional Certificate
About 16 hours
Written for scientists, clinicians, and project managers moving into regulatory affairs roles at drug and biologics sponsors or CROs.
$395 per person. Online and self-paced.
Who it is for
Scientists, clinicians, and project managers moving into regulatory affairs roles at drug and biologics sponsors or CROs.
What you will learn
- Map a product's path from pre-IND through approval and lifecycle management
- Outline the contents of an IND and an NDA/BLA in CTD format
- Choose and justify an appropriate expedited program for a development candidate
- Prepare a well-structured FDA meeting request and briefing package outline
- Explain PDUFA review clocks and key post-approval obligations
How it works
Online and self-paced
The lessons are online, with an audio version of each, so you can study at your own pace.
Earn a certificate
Finish every lesson to receive a certificate with a unique ID that anyone can verify.
Enroll online
Pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.
Questions about this program
How long does US Drug and Biologics Regulatory Pathways Professional Certificate take?
About 16 hours of study. It is online and self-paced, so you can spread it over the weeks that suit you.
Who is this program for?
Scientists, clinicians, and project managers moving into regulatory affairs roles at drug and biologics sponsors or CROs.
Do I get a certificate?
Yes. When you finish every lesson you receive a digital certificate of completion with a unique ID that anyone can check at regulatedscience.org/verify/. You can add it to your LinkedIn profile.
Is there an audio version?
Yes. Every lesson has an audio version, so you can listen on the go.
How much does it cost?
$395 per person. Email support@regulatedscience.org for team pricing.
How do I enroll?
Select "Enroll" on this page and pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.
Can my team take it together?
Yes. We offer group enrollment for companies, CROs and consultancies. Email support@regulatedscience.org with the programs and the size of your team.
Not ready to enroll?
Leave your email and we will send you the syllabus and news about this program. You can ask us to remove it at any time.
