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Click on the tab “RAC-GS Certification Exam” and click on the “New User” link in the upper right-hand corner of the page. Effects of the Regulatory Affairs Professionals Regulatory Affairs Certification Exam (RAC-GS) are explained in detail here.
Enter the needed information such as First Name, Last Name, Username, Password, Confirm Password, Email, Contact Number, Country of Residence, and Contact Information, to create an account. Click on “Register”, as the detail is submitted.
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| Section | Objectives |
|---|---|
| Topic 1: Regulatory Strategy and Compliance | - Quality systems and inspections - Regulatory strategy development |
| Topic 2: Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
| Topic 3: Post-Market Surveillance | - Lifecycle management and variations - Pharmacovigilance and safety reporting |
| Topic 4: Drug Development Lifecycle | - Clinical trial design and regulatory requirements - Preclinical and clinical development stages |
| Topic 5: Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
Regulatory Affairs Certification (RAC) US
Regulatory Affairs Certification (RAC) Global Scope
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