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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Chapter 1 An Overview of Medical and Regulatory Writing
Chapter 2 Good Documentation Practices
Chapter 3 General Considerations for Quality Regulatory Writing
Chapter 4 Guidance Documents: Beyond the Code of Federal Regulations
Chapter 5 Medical Device Submission Considerations Beyond the US, Canada, and EU
Chapter 6 Developing Standard Operating Procedures and Planning and Strategy Documents
Chapter 7 Review and Approval Process
Chapter 8 Clinical Trial Protocols
Chapter 9 Informed Consent Form Preparation
Chapter 10 Data Analysis Plans
Chapter 11 Clinical Study Reports
Chapter 12 Integrated CMC Documentation
Chapter 13 Integrated Nonclinical Documentation
Chapter 14 Integrated Clinical Documentation
Chapter 15 Investigator’s Brochure
Chapter 16 Labeling
Chapter 17 Background Packages
Chapter 18 Responses to Questions or Requests for Information
Chapter 19 Interdisciplinary Document, Dossier Maintenance
Chapter 20 Value Dossiers
Chapter 21 Vaccines and Biologics
Chapter 22 Biosimilars: Special Considerations
Chapter 23 Combination Product Design and Development
Chapter 24 Rare Diseases—Special Considerations for Orphan Designations
Chapter 25 Pediatric Investigational Plan (PIP)
Chapter 26 Accelerated Filings
Chapter 27 Publications
Chapter 28 Literature Reviews
Chapter 29 Lay Summaries of Clinical Study Results
Chapter 30 Future Directions for Regulatory Writing
Every chapter has been updated to reflect new regulations and guidance. Some of these changes were substantial, especially in light of the COVID-19 public health emergency.