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, Medical Writing

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9/24/2018 - 11/26/2018

$675

Online

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• SECTION ID:

  135337

• CLASS TYPE:

  Online, Web-based instruction

• INSTRUCTOR:
  

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

  Yves Theriault has a diversified background and performed in several different types of industries including pharmaceuticals, biotechnology, system engineering, food and nutritional supplements (nutraceuticals), sales, marketing and has implemented corporate strategies in several organizations.
  
  Theriault serves as president of The California Institute for Performance Management founded in 2009. The not 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 Institute, which focuses on organizational performance management, values among other related disciplines, portfolio and project management as well as system engineering methodologies along with the model of the learning organization. The company has also established a tutoring division, The California Institute for Academic Excellence (CIAE), which offers tutoring services to students attending California schools (K-12 and College) recognizing that individual performance starts early in life.

  In July 2015, he was appointed the position of vice-president of portfolio and project management at BlueNovo Biosystems Inc., an early stage biotechnology company focusing on revolutionary genome sequencing technologies as well as rapid profiling diagnostics of infectious diseases.

  Theriault is an active member of the Project Management Institute (PMI) and of the International Council on System Engineering (INCOSE). He has been an instructor at UC San Diego Extension since 2007 and teaches within the realm of Extension’s project management certificate programs. He holds a doctorate degree in chemistry from University of Montreal, certificates in project management and systems engineering from UC San Diego Extension and a Project Management Professional (PMP®) certification from PMI.

   

• TEXTBOOKS:

  No information available at this time.

• POLICIES:

  No refunds after: 10/1/2018.
  

• NOTE:

• DATE & LOCATION:

  9/24/2018 - 11/26/2018
  ucsdextension.blackboard.com
  You will have access to your course on the published start date.