Recommended Literature and Courses (4/6 Drug Development Series)

Certified training is mandatory for most activities in drug development for staff at sponsors, trial sites, vendors or regulatory agencies. A wide range of online and in-person courses exist. The following lists some established providers we have used for training colleagues in the past and a list of strongly recommended complementary reading (think of “most important references used in the series”):

Manufacturing: Video on the 10 principles of GMP (not strongly recommended, but it’s OK; note that it’s not certified)

**Quality Assurance: **Good overview of quality management systems by one QMS vendor (not certified):

Pre-clinical: This is a solid GLP resource (not certified)

Clinical Trials:

• Excellent resource for an overview of clinical trial documents by smartsheets.

• Basic training: Global Health Training Centre: Free high-quality courses on basic topics such as GCP, Data Management, Adverse Event Management and much more.

• Advanced Training: Association of Clinical Research Professionals (ACRP): Paid courses cover a wide range of topics, including advanced courses on quality management, event reporting, etc.

Complementary reading to the Drug development Series :

• General

Research and Development in the Pharmaceutical Industry, Congressional Budget Office

• Costs and barriers to drug development by the Assistant Secretary for Planning and Evaluation (ASPE)

• A History of the FDA and Drug Regulation in the United States

• Manufacturing

COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process (provides a good overview of FDA inspections)

• Clinical trials

ICH efficacy guidelines: Particularly E6:GCP

• Why are clinical trials so complicated? Short article from the Science Magazine

• Study other sponsor’s clinical trial protocols, informed consents, and investigator’s brochures