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Certified Six Sigma Black Belt, has more than 12 years of experience working with high-tech industry leaders such as Intel, SAP, and HP. Mr. Dave specializes in global program and portfolio management in supply chain development, ERP (SAP R/3), enterprise information systems, new product introductions, emerging technologies, and Lean Six Sigma projects.
PMP® is a registered mark of Project Management Institute, Inc.
|Qualifications||M.S., M.B.A, PgMP®|
Consider what it takes to create a safe, effective, high quality pharmaceutical product that complies with global International Conference on Harmonization (ICH) Quality Guidelines. In this course, students review each guideline pertinent to drug development, patient safety, health authority review, and commercial manufacturing. This uniquely robust overview provides an understanding of the regulatory intent, helping to prepare professionals for competitive job roles in San Francisco Bay Area biopharma.
This course explores the fundamentals of statistical methods and reasoning. Topics include descriptive methods, data gathering, probability, interval estimation, significance tests, one- and two-sample problems, categorical data analysis, correlation and regression. The instructor will demonstrate the use of spreadsheets and statistical software to analyze and interpret data. Examples are drawn from a variety of fields including biology, business and marketing. While not too mathematically rigorous for the novice, the course provides some mathematical detail to illustrate basic concepts.
The recent outbreaks of Zika and Ebola viruses and an increase in the rates of certain viral infections reflect the profound impact viruses have on human health worldwide. Students in the course study past viral pandemics—influenza, smallpox, and polio—and how they have altered human history. They survey how viruses replicate in human hosts and spread in human populations. Students also learn how recent developments in molecular biology and genetics have been instrumental to the biopharmaceutical industry in developing antiviral drugs and viral vaccines.
Bioinformatics plays a crucial role in the storage, search, and analysis of biomolecular sequence and structure data. A significant amount of data is now available on the web, along with software tools for data search and analysis.
Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course will help you understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Through lectures, case studies, and hands-on exercises, you'll gain knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, post-marketing requirements, the impact of regulatory differences between U.S.
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|BTEC.X401||Drug Development Process|
This course introduces the essential probabilistic and statistical methods used in bioinformatics and biomedical research. You’ll learn the fundamentals of probability, including first notions, probability axioms, conditional probability, random variables (discrete & continuous), probability distributions, expectation and variance, inferring a binomial proportion, the normal distribution, and the central limit theorem.
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The development of new drugs is a highly complex, lengthy and expensive process. In this course, you examine this process---from discovery to market and beyond---and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures will address drug discovery; preclinical characterization of new drug entities; the phases and purposes of both pharmacological and clinical development; regulatory filings, compliance and oversight; FDA jurisdiction; and strategic issues in drug development.
This introductory course provides a framework for understanding the process of drug discovery, from target selection and validation to lead optimization and preclinical studies. Although the fundamental principles of drug discovery are well established, the tools, technologies and methods used in the discovery and development of safe and effective drugs are constantly evolving. Personalized medicine and novel diagnostics involving biomarkers, pharmacogenetics and pharmacogenomics in clinical practice are changing the landscape of drug discovery.