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RAPS Seeks Authors for Regulatory Writing Book

Posted 25 February 2016 | By

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 pjones@raps.org with the specific topic and a CV.

Available topics are:

Policies, Codes and Guidance for Industry

  1. Overview of ICH guidelines for regulatory documentation
    1. Types (by region)
    2. Purpose
    3. Relationship between documentation and ICH GxP
  2. Guidelines outside of ICH regions
  3. Additional guidelines

Regulatory Study Documents

  1. Forms
  2. Protocols
  3. Informed consents
  4. Data analysis plans
  5. Reports

Interdisciplinary Documents

  1. Investigator’s brochure
  2. Labeling
  3. Background packages
  4. Responses to questions or requests for information

Special Considerations

  1. Vaccines
  2. Rare diseases
  3. PIPs
  4. Accelerated filings
  5. Health economics

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