The Drug Development Process - From Discovery to Commercialization 2013

The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.



Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug.



Topics include:

Basic concepts of drug discovery and testing

Scientific, regulatory, and management framework for modern pharmaceutical development

Pre-clinical study requirements and how information gathered is used for human clinical studies

The four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase

The economics of drug development

Cost/benefit issues in clinical development

Discovery and development milestones

The IND Process

The NDA Process

FDA Interactions – Application review and approval process

Patents and exclusivity

The rationale of government regulations and how they effect the development process

The relationship between the Code of Federal Regulations and ICH GCP

Designing optimal clinical trials

Drug labeling, marketing, and pharmacoeconomic studies

Project management cross functional teams during the development process