John M. Young, Ph.D.
(JM Young Consulting)
Pharmaceutical Research and Development - Discovery to Registration
Independent Contractor providing Discovery, Research, Development and Registration Support to the Pharmaceutical, Biotechnology and Medical Device Industry
UC Berkeley Extension Courses
(Under Construction )
"Overview of The Drug Development Process", April and October 2002-3, San Francisco, CA
A four-day intensive course for professionals in the pharmaceutical, biotechnology, and health-related industries.
This course provides a detailed picture of the complex and highly interrelated activities of the drug and biologics development process, from discovery to a successfully marketed product. Designed for new and experienced professionals from the pharmaceutical, biotechnology, and health-related industries, this course is also useful to venture capitalists, patent attorneys, information specialists, and other service providers who wish to improve their understanding of the industry.
The course directors (John M. Young and Velimir Kuftinec) and nine highly experienced guest speakers will lead you through the major scientific, business and regulatory stages of the drug development process-from the inception of an idea for a New Chemical Entity and its development, through to launch of a successful new compound and beyond.
- Pharmacology, Drug Metabolism, Pharmacokinetics, Toxicology
- Chemistry, Manufacturing and Controls/Pharmaceutical Development
- IND Package
- Phases of Clinical Trials and Clinical Data Management
- NDA Filing, Regulatory Review and Approval Process
- Regulatory Compliance and Quality Assurance
- Global Registration and Approval
- Commercial Development, Strategic Marketing and Planning
- Patents and Intellectual Property
This course is presented in the Spring and Fall of each year. Further details and registration information may be obtained from:
UC Berkeley Extension, Dept. B
1995 University Avenue
Berkeley, CA 94720
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"An Overview of the Drug Development Process", June 2002-3
UCB-Extension, Redwood City, CA
805 (1.8 ceu; 18 CE hours for nurses, BRN provider #00226; 16.5 MCLE hours, provider #1345)
Drug development is a lengthy, complex, and costly enterprise. This course provides a comprehensive overview of the process, focussing on the different functions and roles involved and on the impact different segments of the process have on each other. It is designed for scientific and non-scientific professionals in pharmaceutical, biotechnology, and other health-related industries who want a greater understanding of the complete picture of the drug development process.
In a step-by-step approach, the instructor John M. Young presents an overview of all stages of this process, starting from the inception of an idea for a new compound through market launch and post-marketing surveillance of the successful product. They discuss the discovery process, preclinical studies (including pharmacokinetics and toxicology), clinical trials, CMC/pharmaceutical development, the regulatory review and approval processes, and more. You should leave the course with an understanding and appreciation of drug discovery, development, and commercial activities as an integrated business process that contributes to the successful advancement of a drug to market.
NOTE: I have presented this Course for UCB Extension on Monday and Thursday evenings (3 hrs each) during June for the last four years.
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