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:

Complementary reading to the Drug development Series :


Other articles in this series

  1. Stakeholders in Drug Development
  2. The Blueprint of Drug Development
  3. Origins of Drug Regulation
  4. Recommended Literature
  5. Alvea – A Case Study of the Fastest Biotech to Go to In-Human Trials
  6. Conclusions