Seminar on Clinical Drug Development and Approval Process at Washington

Event Details

Time: July 23, 2015 at 9am to July 24, 2015 at 6pm
Location: Washington DC
Street: Washington DC
City/Town: Washington
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: clinical, food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Apr 22, 2015

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Event Description

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 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.

Why you should attend:

This seminar provides you with an understanding of the process. People often use the term, "Well, it's not rocket science!", to indicate that something is not complicated. They could also use the term "Well, it's not drug development!" The process of clinical drug development utilizes pharmacokinetics, medical, statistics, and other clinically relevant principles to turn a chemical compound into a safe and effective drug.

Speaker:

Robert L. Kunka, Ph.D., is an accomplished and respected scientist who contributed to the development of 28 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.