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CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
5-7 October 2016
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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| Shayne C. Gad, PhD, DABT; Principal, Gad Consulting Services (GCS) |
Dr. Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and after active duty service in the and after active duty service in U.S. Navy, Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, Principal of Gad Consulting Services, a twenty-three year old consulting firm with eight employees and more than 500 clients in the pharmaceutical and medical device industries, including providing QSAR and impurity, leachables and extractables assessments and qualifications. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award in 2008. Served on Council, Membership, Program, and Animals in Research committees for ACT, multiple committees in SOT, and currently on the regulatory opinions committee of the Society of Toxicologic Pathologists. Previously at CMIR Chemical Hygiene Fellowship, Allied Chemical, Searle, Becton Dickinson and Synergen. He has authored or edited 47 published books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug and device development and safety assessment. He has more than 37 years of broad based experience in toxicology, drug and device development, statistics and risk assessment, and has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, risk assessment and genotoxicology. Grant reviewer for EPA, CAAT, NIH, and Canadian Health. He has direct involvement in the preparation of INDs (109 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. Served as the COO of two pharmaceutical companies while a consultant. He initiated and has conducted the triennial toxicology salary survey as a service to the profession of toxicology for the last 37+ years.
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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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jmorbit@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.