Global Medicines Development Online Courses

Shorter and longer e-learning courses based on the materials are available:

1. Introduction to Global Medicines Development

The introductory course provides a detailed introduction to Global Medicines Development for all those wishing to understand the process of bringing a new small molecule or biologic from the laboratory to the market. The course consists of the following 6 modules:
Module 1: Overview of development
Module 2: Screening and nonclinical development
Module 3: Introduction to clinical development
Module 4: Phase I and Phase IIA/Proof of Concept
Module 5: Phase IIB and III studies and pharmacoeconomics
Module 6: Filing for regulatory approval, marketing and recap of the development process
The course requires approximately 25 hours of study, including reading of sections of the e-text, watching narrated videos and case studies including the Alladex case, in which 15 US and EU experts assist a scientist developing a drug from laboratory to market. There are online assessments throughout, leading to a certificate of completion.

 

2. Full Laboratory to Market Case

This unique course follows all the key steps and activities, including associated timelines and costs of bringing a new medicine from discovery through to the market. Using the Medevaid ("Gray Book") e-text and associated spreadsheet tools. This is a unique way to rapidly acquire a practical understanding of the processes involved.

The course is best undertaken following the introductory course. It is suitable for all those wanting to gain a thorough understanding of the process of developing a new drug in practice.
 

Further details are available through admin@graybook.net or Contact/Order

 

 

 

 

 

 

 

July 2017 Updated version of full case released

April 2017  Full Idea to Market Case - small molecule and monoclonal antibody-  released

September 2016  Graybook Spreadsheet Tools released

March 20 2016  EMA launches PRIME scheme to accelerate approval of priority medicines see this link 

September 3 2015 Integrated addendum ICH E6 (GCP guideline) inlcuded in Quicklinks

Jan 6 2015  EMA publishes article on  the adaptive pathways approach -  see this link

October 8 2014 EMA to publish clinical study reports underpinning approvals after January 1 2015 See this link.

September 8 2014 EMA publishes leaflet on EU regulation, see this link.

July 8 2014 Posting of clinical trial results in EudraCT mandatory from July 21 2014 - see this link.

June 6 2014 The European Medicines Agency has selected the first two medicines to be included in its adaptive licensing pilot project.

May 29 2014 Janet Woodcock, Director of FDA's CEDR, discusses accelerated approval procedures on the FDA voice blog and cites latest FDA guidance on this topic.