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In an original CTA or IND for a FIH trial, companies are primarily required to provide information on the safety and quality of the drug (or biologic) to support clinical studies. These summaries are expected in regulatory submissions and are particularly useful for supporting the mechanism of action of drugs and biologics.
Explore the aspects of a nonclinical development program.
Deeply understand how product & indication-specific guidance, as well as basic science, can influence regulatory expectations and program planning.
Know how nonclinical data can be leveraged to support key clinical planning decisions.
Listen to David Horton, subject matter expert in pharmaceutical drug development and Tyler Vandivort, board-certified toxicologist, RAC-Drugs.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.
Great networking and insights from top industry experts.
The event was well worth the time and cost. Would love to attend again.
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