Global CompliancePanel Knowledge, a Way Forward… 2-day In-person Seminar: Clinical Drug Development and Approval Process San Diego, CA Robert Kunka President & Clinical Drug Development and Approval Process Consultant, The Kunka Group, Inc. Robert L. Kunka, Ph.D., is an accomplished and respected scientist who contributed to the developme nt of 28 pharmaceutical products in eight therapeutic areas. His expertise on international product development teams produced submission s 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. Prior to starting his current career as a consultant (The Kunka Group, Inc.), Bob's experience in drug development stems from 24 years in the pharmaceutical industry at GlaxoSmithK line (GSK), Chugai-Upjohn, and GD Searle. Overview Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developin g it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and approvals from the Food and Drug Administration (FDA) website. October 8th & 9th, 2015 9:00 AM to 6:00 PM Robert Kunka Course "Applied Statistics for Scientists and Engineers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RACrecertification upon full completion.
Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval. The course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and approvals from the Food and Drug Administration (FDA) website. The outline for the class will include organization of a pharmaceutical company including preclinical, pharmaceutical development, clinical pharmacology, clinical, and regulatory. Several therapeutic areas will be used in examples. The valuable use of teams will be described by membership and responsibilities. Interactions with different drug company teams will be examined along with interaction with FDA teams.
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