קטגוריה: ניסויים פרה-קליניים , בטיחות המוצר , מו"פ , מומחים מחו"ל
Drug Safety Evaluation during Drug Development and Non-Clinical Studies
הערכת בטיחות התרופה בשלבי הפיתוח והניסויים הפרה-קליניים
מרצה: Dr. Shayne Gad
תאריך: יפורסם בהמשך
מיקום הקורס:  יפורסם בהמשך
שפת הקורס: אנגלית
משך הפעילות: 3 ימי לימודים מלאים
שעות:  09:00-17:00
התכנסות והרשמה: 09:00 - 08:30
עלות: 6,450 ש"ח + מע"מ
נקודות זכות: 3
מק''ט: 13281
 

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.

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
Issues to be covered
  • 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
  • AND – a practicum – “The IND Game”
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
About the Speaker

Dr. Shayne C. Gad has been the Principle of Gad Consulting Services for 16 years.  His 32 years of experience includes safety assessment in the medical device, biotechnology, pharmaceutical and chemical industries.  He has published 39 books and more than 350 abstracts, articles and chapters in the fields of toxicology, statistics and safety assessment, pharmaceutical and medical device development, and is on the editorial boards of the Journal of Applied Toxicology, The International Journal of Toxicology, the Journal of Inhalation Toxicology and the Journal of Acute Toxicology.

He was Editor-in-Chief for Toxicology Methods, and has successfully opened 88 INDs in the past 16 years.  He served on the Consumer Product Safety Commission Toxicology Advisory Board, and numerous NIH review committees and Advisory Boards.

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