RAPS Seeks Authors for Regulatory Writing Book
RAPS is planning to publish a regulatory writing handbook later this year and is seeking contributing authors. Chapters will be due in late summer. If you or a colleague have expertise in any of the available topics and would be interested in sharing that knowledge, please contact Senior Editor Pam Jones at [email protected] with the specific topic and a CV.
Available topics are:
Policies, Codes and Guidance for Industry
- Overview of ICH guidelines for regulatory documentation
- Types (by region)
- Purpose
- Relationship between documentation and ICH GxP
- Guidelines outside of ICH regions
- Additional guidelines
Regulatory Study Documents
- Forms
- Protocols
- Informed consents
- Data analysis plans
- Reports
Interdisciplinary Documents
- Investigator’s brochure
- Labeling
- Background packages
- Responses to questions or requests for information
Special Considerations
- Vaccines
- Rare diseases
- PIPs
- Accelerated filings
- Health economics