Regulatory Focus™ > News Articles > Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

Posted 05 May 2016 | By

Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types. All medical device chapters have been assigned. Outlines will be due 15 June 2016 and chapters will be due 1 September. If you are interested in participating in this project, please send your CV and the chapter(s) of interest to Pam Jones, senior editor.

Authors are still needed for the following chapters:

Section I General Information

  • Crisis Management
  • Health Technology Assessment
  • Advertising and Promotion
  • Compliance and Enforcement
  • Counterfeit Deterrence

Section II Pharmaceuticals

  • Authorization Procedures for Pharmaceutical Products
  • Stability Test Requirements
  • Quality Systems and Inspection Processes—Pharmaceuticals
  • Generic Drug Products
  • Nonprescription Products
  • Pharmaceutical Postmarketing and Compliance
  • Pharmacovigilance

Section III Biologics

  • High-Risk Products: Products Derived from Biotechnology
  • Biosimilars
  • Vaccines

Section V Other Product Types

  • Products Manufactured From Human Blood or Plasma
  • Human Cell and Tissue Products
  • Regulation of Regenerative Products
  • Cosmetic Products
  • Food Supplements
  • Veterinary Medicinal Products
  • Botanical Drug Products and Traditional Medicine

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