Your cart is empty.

The Most-Trusted Regulations & Guidelines Books on the Market.
Celebrating 18 Years of Excellence.

Now Accepting Orders for our REVISED APRIL 1, 2020 Books

Book 18:  SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval

Book 18: SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval

$ 15.95

Return to Previous Page

This spiral-bound, 5" x 7.5" book consists of two documents translated into Spanish:  The ICH Guideline for Good Clinical Practice and the FDA CDER Handbook on the drug approval process.

It contains a primer on the drug development process, a review of how FDA evaluates and approves drugs; as well as the responsibilities of sponsors, investigators, and IRBs/IECs in protecting human subjects under Good Clinical Practice.  It's an ideal introduction for Spanish-speaking staff to the field of drug development and a handy reference for seasoned Spanish-speaking clinical research professionals.

As more and more clinical trials are being conducted in Spanish-speaking countries, this books helps bridge the language barrier between Spanish-speaking and non-Spanish-speaking affiliates.

What's the Price?
• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

Custom Cover Prices*?

• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

• ICH E6:  Guideline for Good Clinical Practice

  [Guia Tripartita Armonizada de la Conferencia Internacional
   de Amonizacion Lineamientos para la Buena Practica Clinica]

• FDA Center for Drug Evaluation and Research:
  Handbook on the Drug Approval Process

  [Manual del Centro para la Evaluacion e Investigacion de
  Farmacos (CDER)]

Click here to see an enlarged pdf cover