RAPS Seeks Authors for EU Fundamentals Book

Posted 09 March 2017 By RAPS Staff

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The eighth edition of Fundamentals of EU Regulatory Affairs will be published in December 2017. RAPS currently is seeking authors for chapters, which will be due no later than 1 August 2017. If you would like to contribute to this book, please review the list of currently available chapters below and send your CV and your preferred chapter(s) to Pam Jones, senior editor, at pjones@raps.org or submit a volunteer application online. Emails or applications must be received by 31 March.

Section I: General Information

  • History of EU Regulation
  • Overview of Drug and Biologic Regulatory Pathways
  • Preparing for EMA and Other Agency Meetings
  • EU Pricing and Reimbursement
  • EU Regulatory Affairs—Health Technology Assessment
  • Advertising and Promotion
  • Enforcement and Competent Authorities
  • EU Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery
  • Regulatory Strategy
  • Exclusivity and Patents

Section II: Medical Devices

  • MDD and Classification of Medical Devices
  • Active Implantable Medical Devices
  • Essential/Technical Requirements (AIMD, MDD, IVDD)
  • Preclinical Testing
  • Medical Device Conformity Assessment Procedure
  • Medical Device National Particularities

Section III: Medicinal Products

  • Overview of Authorisation Procedures for Medicinal Products
  • Adaptive and Alternative Pathways
  • Medicinal Product Clinical Trials and Good Clinical Practices
  • Registration Procedures for Medicinal Products
  • Quality Systems and Inspectorate Process—Pharmaceuticals
  • Generic Medicinal Products
  • Nonprescription Medicinal Products
  • Marketing Authorisations for Products Derived From Biotechnology
  • Pharmaceutical Postmarket Requirements and Compliance with the Marketing Authorisation
  • Pharmacovigilance
  • Regenerative Medicine Regulation: Cell Therapy, Gene Therapy and Tissue Engineering
  • Human Tissue Regulation
  • Vaccines

Section IV: Foods

  • Food Supplements
  • Food for Special Medical Purposes

Section V: Other Product Classifications

  • Products Manufactured From Human Blood or Plasma
  • Orphan Medicinal Products
  • Combination Products
  • Cosmetics Regulation in the EU
  • Veterinary Medicinal Products

Section: VI

  • Regulatory Resources

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