Overview of the Drug Development Process

Guiding a new product through the stages of research, development, clinical trials and submission of an IND and New Product Marketing Application requires the input of nearly every area within a pharmaceutical company. This course presents a road map for taking the product from bench-scale operations in the research laboratory to full-scale manufacturing production and the requirements for GMP product approval. Pitfalls will be discussed and consideration will be given to the regulatory and quality requirements at each step.

Course Number: BIOL-40015
Credit: 3.00 unit(s)
Related Certificate Programs: Drug Discovery and Development

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9/28/2020 - 12/2/2020

$675

Online

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• SECTION ID:

  150800

• CLASS TYPE:

  Online Asynchronous.
  
  All instruction and course materials delivered and completed online between the published course start and end dates.

• INSTRUCTOR:

  Theriault, Yves, President, The California Institute for Performance Management; Vice-President, Portfolio and Project Management, BlueNovo Biosystems, Inc.

  Yves has a much diversified background which includes multi-disciplinary expertise in the fields of life sciences, pharmaceutical and biotechnology, as well as business and project management. Over the last 3 decades, he has performed in several different types of industries to include pharmaceuticals, biotechnology, system engineering, food and nutritional supplements (nutraceuticals), sales and marketing and has also implemented corporate strategies in several organizations. Yves is President of The California Institute for Performance Management founded in 2009. The non for profit corporation offers educational services to professionals seeking self development and to companies desirous of training their work force in order to achieve optimum organizational performance. The Instit...Read More

• TEXTBOOKS:

  No textbook required.

• POLICIES:

  No refunds after: 10/5/2020.
  

• NOTE:

• DATE & LOCATION:

  9/28/2020 - 12/2/2020
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.