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Navigating the Investigational New Drug (IND) Application Process

  January 24, 2024  
Xtalks, Online

Discover an informative webinar delving into the investigational new drug (IND) application process, a pivotal milestone in drug development. The IND application is an important milestone in drug development. An IND aims to demonstrate every aspect of the drug is safe for human exposure. Sponsors need to evaluate IND readiness to ensure they have enough data to support the initiation of clinical trials. Submission of an incomplete IND lacking important studies or data can lead to a clinical hold, thus delaying clinical trials and increasing costs for the sponsor.

Join this webinar to explore the drug development process with specific insights into The Food and Drug Administration’s (FDA) regulations, including an overview of the required content for a successful IND application and recommended interactions with the agency to ensure success.

Keywords: Clinical Trials, FDA, Drug Approval, Clinical Research, Drug Safety, FDA Approval, Investigational New Drug, Regulatory, IND submission, CDMO/CMO, Toxicology/Safety
Organized by: Xtalks
Invited Speakers: Paula Garcia Calavia, PhD, Director, Regulatory Affairs, Pace Life Sciences
Deadline for Abstracts: 2024-03-06
Registration: Free Registration
E-mail: tristan@xtalks.com
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