Extending Your Drug's Life

    /Robert L.  /Kunka, Ph. D.speaker of compliance global
    Speaker: Robert L. Kunka, Ph. D.
    Duration: 90 Minutes
    Product Code: 700184
    Level: Intermediate
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overview

This webinar will describe how a pharmaceutical company can prolong the life of a drug product. The high cost of time, money, and man-hours to develop a new pharmaceutical drug requires that the company hang onto the drug especially during the patent period. Examples will include new formulations, indications, and additional patient populations. Healthy pharmaceutical companies take pride in adding years to a drug’s patent process life. People who are responsible for this result are often promoted because of the positive effect on the company’s health.

why should you attend

Healthy pharmaceutical companies take pride in adding years to a pharmaceutical product’s life.  People who are responsible for this result are often promoted because of the positive effect on the company’s health. As employees stay with the company and get older, there is often a fear that the company will not continue to keep a person employed especially as he/she gets closer to pension age. They need to get associated with a drug’s name and longevity.

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Areas Covered

Pharmaceutical companies have numerous areas that are associated with most drugs. In the business side marketing looks to prepare advertising to prescribers and potential patients.  Pharmaceutical manufacturing areas develop a new formulation and their colleagues make the new product for millions of patients. Scientists working with animals obtain basic safety information for a particular population that does not have data in the past. Clinical scientists develop safety, pharmacokinetic, and efficacy data in man to form the core of the data needed to get approved. Regulatory colleagues interact with regulatory agencies and team members to prepare important documents.

Learning Objectives

This webinar will describe how a pharmaceutical company can prolong the life of a drug product using:

  • New formulations,
  • Indications, and 
  • Additional patient populations

WHO WILL BENEFIT

  • Project Managers
  • Formulation Development Professionals
  • Preclinical Development Professionals
  • Clinical Development Professionals
  • Regulatory Compliance Professionals

SPEAKER

Robert L. 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 GlaxoSmithKline (GSK), Chugai-Upjohn, and GD Searle.

Prior to this, he was Assistant Professor at the University of Pittsburgh School of Pharmacy where he taught graduate and undergraduate courses in pharmacokinetics. Bob earned his Ph.D. in Pharmacokinetics at the University of North Carolina (UNC) at Chapel Hill and Bachelor of Science in pharmacy at the University of Illinois at the Medical Center in Chicago. While at UNC, he was honored to be named the American Foundation for Pharmaceutical Education Charles J Lynn and Syndor Barksdale Penick Memorial Fellow. Bob has been consulting (The Kunka Group, Inc.) since 2008.

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