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Regulatory Medical Writing Bundle [Complete Package]

Product Bundle Product Bundle Member: $1,240.00 Nonmember: $1,710.00

Regulatory Medical Writing Bundle [Complete Package]

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

Products included in this bundle:

Online Course: Introductory Medical Writing

  • 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
3–6 Hours | 3 RAC Credits

Online Course: Intermediate Medical Writing: Investigational Applications

  • 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
6–12 Hours | 6 RAC Credits

Online Course: Intermediate Medical Writing: Medical Devices

  • Lesson 1: Premarket Approval (PMA)
  • Lesson 2: 510(k) Premarket Notification
2–4 Hours | 2 RAC Credits

Online Course: Intermediate Medical Writing: Pharmaceuticals and Biologics
  • Lesson 1: Common Technical Document (CTD)
  • Lesson 2: New Drugs Application (NDA)
  • Lesson 3: Biological License Application (BLA)
  • Lesson 4: Marketing Authorisation Application (MAA)
3–6 Hours | 3 RAC Credits

This online course is accessible for six months from the date of purchase.

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