Pediatric Drug Development: Regulatory Expectations with New Laws

The art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last 10 - 14 years because of the encouragement of regulatory agencies in Europe and United States.

Speaker: Robert Kunka | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Building a Successful Relationship with the US FDA: Key Steps

Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.

Speaker: Robert Kunka | View Anytime | Duration: 90 Minutes | Price: $127.00 | View Details

Developing an Efficient Relationship with FDA

Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.

Speaker: Robert Kunka | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details