Pre-Clinical Drug Safety Evaluation in Drug and Biologic Development

מרצה: Dr. Shayne Gad

תאריך: יפורסם בהמשך
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 15694
שפת הקורס: אנגלית
על הקורס

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.

קהל היעד
  • Scientists who wish to gain an understanding of pharmaceutical toxicity studies
  • Managerial personnel
  • Project management staff
  • Regulatory Scientists involved in preclinical development
  • Investors
Pre-Clinical Drug Safety Evaluation in Drug and Biologic Development
התועלת שתופק

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
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Introduction to non-clinical safety assessment
  • History and importance of non-clinical safety
  • Overview on the drug development process
  • Candidate compound selection: Discovery screens and early tox/ADMET
  • Reviewing prior art: Sources of information for consideration in study and program design
  • Contracting studies to outside labs (CROs)
  • Toxicokinetics
  • Basic principles of toxicity testing
  • Toxicological manifestations/mechanisms/endpoints
  • Single dose toxicity studies
  • Nonclinical Dose Selection
  • Genotoxicity studies
  • Carcinogenicity testing
  • Local tolerance studies (skin/eye irritation; local vascular and muscular irritation;pyrogenicity)
  • Reproductive and development toxicity studies (continued)
  • Safety pharmacology
  • Additional special studies (immunogenicity; allergy; skin sensitization)
  • Strategic planning of the non-clinical phase
  • Safety testing of biotechnologically derived products
  • The Investigator’s Brochure
  • Formulations and Excipients
  • Regulatory requirements and procedures – The FDA & ICH
  • Regulatory: The Common Technical Document (CTD)
  • Extrapolation of animal data to humans and first-in-man (FIM) studies
אודות המרצה

Dr. Shayne Gad

The principal of Gad Consulting Services, has more than 29 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology.
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