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CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
15-17 June 2015
Who Should Attend?
This course is designed for a broad range of pre-clinical, clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical companies. It will be of special value to:
• Scientists who wish to gain an understanding of
pharmaceutical toxicity studies
• Managerial personnel
• Project management staff
• Regulatory Scientist involved in preclinical development
• Investors Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Dr. Shayne C. Gad; Principal of Gad Consulting Services |
Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, is the principal of Gad Consulting Services, a twenty-three year old consulting firm with six employees and more than 450 clients in the US and overseas. Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson, as a manager of the toxicology lab at Allied Signal, and at Chemical Hygiene Fellowship at Carnegie Mellon Institute.
Dr. Gad has published 47 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and medical device development and safety assessment. He has previously served as a Counselor and President for ACT, as President of three SOT specialty sections and the Roundtable of Toxicology Consultants, as a reviewer for NIH, and editor of two journals. He has also conducted the triennial salary survey for toxicologists. He has more than 37 years of broad based experience in these fields and has successfully filed more than 106 INDs.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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Emphasis will be placed on how toxicity studies are integrated into the multidisciplinary development plans of new drugs and biologics, and how they affect development decisions. Regulatory affairs will be covered, and descriptions given of the European and the U.S. FDA requirements, the new drug review process, and common regulatory errors.
The goal of this course is to give a working knowledge of pharmaceutical toxicology and drug development to enable you to develop new drugs faster and more efficiently.
There will be ample opportunities for participants to introduce topics for discussion and to interact with the faculty. The “IND Game” will provide practical experience in early drug development.