Speaker Profile


Robert Kunka

President & Clinical Drug Development Consultant, The Kunka Group, Inc.

Bob Kunka Ph.D. is an accomplished and respected scientist who contributed to the development of 28 approved pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submissions with successful clinical strategies, sound matrix management of individual study teams, and effective interactions with regulatory agencies leading to successful IND, aNDA, and NDA approvals.

Bob’s experience in drug development stems from 24 years in the pharmaceutical industry at three companies. Prior to this, he was Assistant Professor at the University of Pittsburgh where he taught undergraduate and graduate courses in pharmacokinetics. He earned his Ph.D. in pharmacokinetics at the University of North Carolina at Chapel Hill and has a B.S. in pharmacy at the University of Illinois at the Medical Center.

Bob has been consulting (The Kunka Group, Inc.) since 2008 and will be presenting at the 2014 World Congress of Basic and Clinical Pharmacology meeting in Cape Town, South Africa on July 17 as a member of a program entitled The Changing Face of Pediatric Drug Development. The title of his talk is Pediatric Drug Development from the Sponsor’s Perspective and Bridging to Relevant Data.

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  • Recorded
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  • 90 Minutes
  • $189.00
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.

  • Recorded
  • View Anytime
  • 90 Minutes
  • $127.00
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.

  • Recorded
  • View Anytime
  • 90 Minutes
  • $190.00
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.

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