Developing an efficient relationship with fda

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Live Webinar Developing an Efficient Relationship with FDA Date: Tue, December 16, 2014

Time: 10:00 AM PST | 01:00 PM EST

Instructor:Robert Kunka

Location: Online

Duration: 90 Minutes

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Overview: 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.

Areas covered in the session: Organization of the FDA Stages in drug development Important meetings with the FDA Logistics of regulatory meetings Content of protocols and clinical reports Outline of IND and NDA application

Who Will Benefit: Formulation Managers and Scientists Project Managers Pharmacokineticists Clinical Research Scientists (CRS) and Associates (CRA)

About Speaker Robert Kunka President & Clinical Drug Development Consultant, The Kunka Group, Inc. Robert Kunka Ph.D. is an accomplished and respected scientist who contributed to the development of 28 approved pharmaceutical products in eight therapeutic areas.

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