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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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May 01, 2013 |
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Center for Professional Innovation & Education, Inc., Berlin, Germany
Oct. 23 - 25, 2013
Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug. Topics include: Basic concepts of drug discovery and testing ; Scientific, regulatory, and management framework for modern pharmaceutical development ; Pre-clinical study requirements and how information gathered is used for human clinical studies; the four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase; the economics of drug development ; cost/benefit issues in clinical development ; discovery and development milestones; the IND Process; the NDA Process; FDA Interactions – Application review and approval process; patents and exclusivity; the rationale of government regulations and how they effect the development process; the relationship between the Code of Federal Regulations and ICH GCP; designing optimal clinical trials; drug labeling, marketing, and pharmacoeconomic studies; project management cross functional teams during the development process.
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Organized by:
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Center for Professional Innovation & Education |
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Invited Speakers:
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Contact info@cfpie.com for a list of course instructors
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Deadline for Abstracts:
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n/a
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Registration:
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http://www.cfpie.com/showitem.aspx?productid=025&source=hummolgen
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E-mail:
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info@cfpie.com
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