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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9/27/2021 - 12/1/2021

$675

Online

Closed

• SECTION ID:

  159599

• CLASS TYPE:

  Online Asynchronous.
  
  This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
  You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

• 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, nanotechnology, systems engineering, pharmaceutical and biotechnology strategic product research and development, leadership, organizational performance, strategic program and project management. He is Program Manager for Education and Outreach Programs at the UC San Diego-based Qualcomm Institute (QI). At QI, he develops and implements educational programs focused on convergence education at the vertex of science, technology, and society. He also develops and teaches courses involving highly integrated multidisciplinary science and engineering program and project management, leadership in the science and technology env...Read More

• TEXTBOOKS:

  No textbook required.

• POLICIES:

  No refunds after: 10/4/2021.
  

• NOTE:

• DATE & LOCATION:

  9/27/2021 - 12/1/2021
  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.