Details
Understanding the regulatory landscape is paramount in the journey from preclinical research to Investigational New Drug (IND) and New Drug Application (NDA) approvals. This webinar has been conducted by Adgyl Lifesciences to provide a comprehensive overview of the key regulatory considerations during preclinical development.
We’ll delve into the essential role of toxicology studies, including the necessity of mammalian studies alongside evolving alternative approaches. Learn about the primary goals of preclinical testing, the critical role of non-clinical data in drug development, and the prerequisites for a successful IND and NDA program.
Key topics covered:
- Understanding the preclinical toxicity tiered testing scheme
- Strategic species selection for robust safety data
- Key regulatory decision-making considerations
- Applying regulatory toxicology to effective risk assessment
- Navigating the drug approval process and engaging with regulatory authorities
- Essential considerations for selecting and working effectively with Contract Research Organizations (CROs)
Who should attend:
Researchers, drug development scientists, regulatory affairs professionals, and anyone involved in the preclinical stages of pharmaceutical development.
Speakers
Ks RaoConsultant Invivo – BD Adgyl Lifesciences Dr. K.S. Rao is a Board-Certified Toxicologist with more than 50 + years of global experience in safety evaluation. Dr. Rao has been providing guidance on product development to hundreds of companies across the world with a major emphasis on testing schemes/strategies and Risk Assessment. He is an Emeritus Member of the Society of Toxicology (SOT) in USA. Dr. Rao is the recipient of the Lifetime Achievement award from the Society of Toxicology of India (STOX) and is the recipient of the Toxicologist Mentor Award from the Society of Toxicology (SOT).