Regulated Science Institute
AI Governance in Drug and Device Development Professional Certificate cover

Data, AI & Real-World Evidence$395Certificate

AI Governance in Drug and Device Development Professional Certificate

About 14 hours

Written for regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.

$395 per person. Online and self-paced.

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Who it is for

Regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.

What you will learn

  • Define the context of use and risk level for an AI model
  • Apply FDA's credibility assessment steps to a drug development use case
  • Outline a PCCP for an AI-enabled device
  • Determine EU AI Act obligations for a product or internal tool
  • Draft an AI governance policy for a GxP organization

How it works

  1. Online and self-paced

    The lessons are online, with an audio version of each, so you can study at your own pace.

  2. Earn a certificate

    Finish every lesson to receive a certificate with a unique ID that anyone can verify.

  3. Enroll online

    Pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.

Earn a verified certificateFinish every lesson to receive a certificate with a unique ID that employers can check. Add it to LinkedIn in one click.See a sample

Questions about this program

How long does AI Governance in Drug and Device Development Professional Certificate take?

About 14 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?

Regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.

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.

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Program
Regulated Science Institute
Programs
Regulatory Affairs 5
Clinical Operations 4
Quality & Compliance 5
Drug Safety & Pharmacovigilance 2
Market Access & HEOR 2
Data, AI & Real-World Evidence 2
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