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Non-Clinical Drug Safety Evaluation and Drug Development

  January 14, 2013  
CfPA - The Center for Professional Advancement, Burlingame, CA
May 6-8, 2013

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

This course provides a comprehensive explanation of the nonclinical development of drugs and biologics, emphasizing the principles of pharmaceutical toxicology and the assessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and project management.

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.

Maximize Your Learning!
Attend this course and its Companion Course:
Pharmacokinetics—ADME Fundamentals 
May 9-10, 2013 • Burlingame, CA • Course ID #2077

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Dr. Shayne C. Gad; Principle, Gad Consulting Services

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, an eighteen 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 44 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 34 years of broad based experience in these fields.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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