Non-Clinical Drug Safety Evaluation in Drug and Biologic Development

Lecturer: Dr. Shayne Gad

Date: 22, 23 January 2020
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 9:00 – 17:00
Price: 4,300 NIS + VAT
Credit Points: 2
SKU: 20694
Course Language: English
About the Course

This course provides a comprehensive explanation of the non-clinical development of drugs, biologics and combination products, 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 safety assessment (“toxicology”) 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.

Who should attend
  • Scientists who wish to gain an understanding of pharmaceutical toxicity studies
  • Managerial personnel
  • Project management staff
  • Regulatory Scientists involved in preclinical development
  • Investors
Non-Clinical Drug Safety Evaluation in Drug and Biologic Development
Benefits to the Participants
Participants will complete this course with an in depth understanding of a working knowledge of pharmaceutical toxicology and drug development to enable you to develop new drugs faster and more efficiently.
  • Address the strategic, scientific and regulatory concerns for the non-clinical development of drugs, biologics and combination products
  • Determine how toxicology studies fit into the multi-disciplinary development scheme for new drug development and influence development strategies
  • Better prepare yourself for a wide range of positions in pharmaceutical R&D
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Issues to be covered
Day 1

Drugs and Biologics:
  • A. Overview of the Drug Development Process
  • B. Toxicological Manifestations/Mechanisms/Endpoints (Tox M, M, & E)
  • C. Paths to Market Approval – The Kinds of NDAs
  • D. Pilot Studies (MTD’s and DRF’s)
  • E. Repeat-dose Toxicity Studies
    • Test Item Calculator
  • F. Nonclinical dose selection
  • G. Genotoxicity Studies
  • H. Safety Pharmacology Studies for Human Pharmaceuticals
  • I. Toxicokinetics and Pharmacokinetics
EVENING SESSION: Contracting Studies to Outside Labs

Day 2
  • J. Carcinogenicity Studies
  • K. Local Tissue Tolerance
  • L. Reproduction and Development Toxicity Studies
  • M. Additional Special Studies: Immunotoxicology, Dermal Sensitization, and Phototoxicity
  • N. Safety Testing of Biotechnology Derived Products
  • O. Formulations and Excipients
  • P. Impurities and Degradents
  • Q. Assessing the safety of oncology, gene therapy, vaccine, and antibiotic products

  • Appendix A   Acronyms
  • Appendix B   Definition of Terms and Lexicon of "Clinical" Observations in Nonclinical (Animal) Studies
  • Appendix C   Notable Regulatory Internet Addresses
  • Appendix D   Nonclinical Drug Toxicology CRO’s

About The Lecturer

Dr. Shayne Gad

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. (U of T at Austin, Pharmacology/Toxicology, 1977), DABT, is the principal of Gad Consulting Services, a twenty-eight year old consulting firm with ten employees and more than 600 clients in the US and overseas.
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