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Course

Overview of the Drug Development Process

BIOL-40015

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 Information

Online
3.00 units
$725.00

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Course sessions

Closed

Section ID:

183774

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.

Textbooks:

No textbook required.

Policies:

  • No refunds after: 10/7/2024

Schedule:

No information available at this time.
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Instructor: Yves Theriault, PhD, PMP

Yves Theriault, PhD, PMP

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 environments, and nanotechnology convergence and its multiple distributive applications. 

Yves is also President of The California Institute for Performance Management (CALIPM) founded in 2009. The non-for-profit company offers continuing educational services to students and professionals performing in academic and commercial organizations.  CALIPM has also established a tutoring division, The California Institute for Academic Excellence, which offers tutoring services to students attending California schools (K-12 and College) recognizing that individual performance starts early in life. He also serves as Executive Director of Education and Outreach for the San Diego Nanotechnology Infrastructure (UC San Diego-based), one of the 16 NSF funded National Nanotechnology Coordinated Infrastructure centers of excellence in nanotechnology. 

Yves is a certified Project Management Professional (PMP®) and an active member of the Project Management Institute (PMI) and of the International Council on System Engineering (INCOSE). He has also been instructor at UC San Diego Extension since 2007. He holds a doctorate degree in Chemistry from University of Montreal, a Certificate in Project Management and a Certificate in Systems Engineering from UC San Diego, and a PMP certificate from the Project Management Institute (PMI).
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