Pharmaceuticals

Note: If you have already taken a RAPS Online University course that is eligible for this certificate program, you may be able to apply it toward the program requirements and registration fee. Contact us to see if your course(s) qualifies.

How Is the Certificate Achieved?
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five of the elective courses outlined below. You will have six months to complete all nine courses. After successfully completing all nine courses, you will receive a certificate recognizing your achievement.

How to Upgrade to the Dual Certificate
If you already have a Regulatory Affairs Certificate in Medical Devices or Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate, not provided as part of your original program, and three additional electives to receive recognition of satisfactory achievement of the Dual Certificate.

What makes up a RAPS Online University Course?
Courses are composed of several topical lessons featuring interactive exercises, detailed explanatory text, engaging graphics, as well as hyperlinks to additional reference material and resources. A short quiz at the end of each lesson measures your incremental learning and an all-inclusive final exam measures your overall comprehension of the course's subject. Navigate through course lessons at your own pace and schedule. View a course demo »

Core Courses (Required)

• Ethics
• Global Regulatory Strategy for Pharmaceuticals
• Pharmaceuticals: Definition & Lifecycle
• Role of the RA Professional

Elective Courses (Select five from the list below)

• Chemistry, Manufacturing and Controls (CMC)
• Effective Communication & Negotiation
• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)
• Intermediate Medical Writing: Biologics and Pharmaceuticals
• Introduction to Global Healthcare Product Regulations
• Introductory Medical Writing
• Pharmaceuticals: Canada Regulations
• Pharmaceuticals: Compliance and Audits
• Pharmaceuticals: EU Regulations
• Pharmaceuticals: US Regulations
• Pharmacovigilance
• Project Management for Regulatory Professionals
• Regulation of Combination Products
• Regulation of Dietary Supplements and NHPs
• Regulation of US and EU Biologics
• REMS and RMPs
• Supplier Management
• Understanding and Managing the US Clinical Trial Process