DPM Training Programme reading list

This reading list contains the some of the most important and relevant resources to assist individuals with their training in Pharmaceutical Medicine and to help candidates prepare for the Diploma exam.

Please note: the practice of Pharmaceutical Medicine is constantly being updated and no single reading source fully reflects this.

General Reading

• The Textbook of Pharmaceutical Medicine, 7th Edition (ISBN: 9780470659878)
• Principles and Practice of Pharmaceutical Medicine, 3rd Edition (ISBN:9781405194723) Pharmaceutical Medicine (Oxford Specialist Handbook), 1st Edition (ISBN: 9780199609147)
• How to Read a Paper: The Basics of Evidence-Based Medicine, 6th Edition (ISBN:
  9781119484745)
• Dictionary of Pharmaceutical Medicine, 4th Edition (ISBN: 9783319506685)

Drug Safety

• Good Pharmacovigilance Practice Guide (MHRA Purple Guide) 2009/2010 (ISBN: 978 0 85369 834 0 2009 / 2010)
• Safer Medicines, The Academy of Medical Sciences 2005

Non-Clinical Safety Testing

• ICH M3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
• ICH S6 (R1) Pre-Clinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Clinical Pharmacology

• Guidelines for Phase 1 Clinical Trials, ABPI 2018
• Guideline on Strategies to Identify and Mitigate Risks for FIH Clinical Trials with IMPs, CHMP 2017
• Textbook of Clinical Pharmacology and Therapeutics, 5th Edition (ISBN: 9780340900468)
• Clinical Pharmacology and Therapeutics Questions for Self-Assessment, 3rd Edition (ISBN: 9780340947432)
• First in Human Studies, ABPI 2011
• Guideline on Strategies to Identify & Mitigate Risks for First-in-Human & Early Clinical Trials with Investigational Medicinal Products, EMA 2017
• High-Yield™ Cell & Molecular Biology, High Yield Series, 3rd Edition

Medicines Regulation

• Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (ISBN: 9783764383619)

Statistics and Data Management

• ICH E9 Statistical Principles for Clinical Trials
• Statistical Thinking for Non-Statisticians in Drug Regulation, 2nd Edition (ISBN: 9781118470947)

Clinical Development

• Clinical Research Manual 2017 Edition, Euromed Communications
• Declaration of Helsinki, World Medical Association 2013
• Medical Ethics Manual 3rd Edition, World Medical Association 2015
• EU Clinical Trials Regulation 2014
• EU Commission Directive 2005/28/EC
• ICH E6(R2) Guideline for Good Clinical Practice
• UK Clinical Trial Regulations (SI 2014 No. 536)
• Good Clinical Practice for Clinical Trials, MHRA 2014

Healthcare Marketplace

• Code of Practice for the Pharmaceutical Industry, ABPI 2019
• Adapting the Innovation Landscape, ABPI 2015