Developing an Efficient Relationship with FDA
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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.
The FDA and other regulatory agencies produce numerous guidances on specific topics that are very helpful. However, there are other issues that can interfere with the developmental process. This presentation will identify these potential problems and recommend how to address them. The areas covered will include: stages of drug development, company teams for developing a drug, relevant structure of the FDA, process of contacting the FDA, important milestone meetings and documents, preparation for meetings, resolve potential issues, and logistics.
This webinar should be "required reading" for those who want to be a member of a drug project team and any of the sub-teams. The first step in the drug development approval process is knowing what needs to be done. When the company starts interacting with the FDA, knowing the steps that are required will likely give the FDA some initial confidence of the proposed plan.
Areas Covered in the Session:
Who Will Benefit:
- 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
- Formulation Managers and Scientists
- Project Managers
- Clinical Research Scientists (CRS) and Associates (CRA)
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.