Product Bundle

Regulatory Medical Writing Bundle [Complete Package]

0.0 RAC Credits Member: $1,240.00 Nonmember: $1,710.00

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Regulatory and medical writing is an integral part of the product development and approval process. It is a skill that must be honed and refined as you gain regulatory knowledge and experience. Learn more about the components of various application types and techniques for improving document quality.

Total Length: 14 Hours
RAC Points: 14
Learning Level: Basic

• Lesson 1: Importance of Medical Writing from a Regulatory Perspective
• Lesson 2: Crafting an Effective Message
• Lesson 3: Basic Statistics
• Lesson 4: Improving Document Quality

• Lesson 1: Investigational New Drug Application (IND)
• Lesson 2: Investigational Device Exemptions (IDE)
• Lesson 3: Canadian Clinical Trial Application
• Lesson 4: Investigational Testing Authorization (ITA)
• Lesson 5: Investigational Medicinal Product Dossier (IMPD)
• Lesson 6: European Clinical Trial Application

• Lesson 1: Premarket Approval (PMA)
• Lesson 2: 510(k) Premarket Notification

• Lesson 1: Common Technical Document (CTD)
• Lesson 2: New Drugs Application (NDA)
• Lesson 3: Biological License Application (BLA)
• Lesson 4: Marketing Authorisation Application (MAA)