SOURCE: Xtalks

Xtalks Webinars

October 25, 2017 07:30 ET

Best Practices in Clinical Pharmacology Gap Analysis, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - October 25, 2017) - Attend this live webinar on November 14, 2017 to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from Investigational New Drug (IND) to NDA. By attending this webinar, you will learn the following:

  • What questions the agency will ask about your clinical pharmacology data package at the time of an NDA submission
  • How gap analysis can help you develop a clinical pharmacology development strategy that covers all relevant domains
  • What data to gather and when to gather it to enhance decision-making during development
  • How a clear clinical pharmacology plan can assist in negotiations with regulators and investors during IND development
  • What quantitative analyses (pharmacometrics and other model-informed drug development technologies) can be leveraged to diminish dedicated study needs and accelerate your path to drug approval

Submitting your New Drug Application (NDA) to the US Food and Drug Administration (FDA) is the ultimate test of a drug program. Are you confident that you'll have robust answers to the 40 different questions that the agency will ask about your clinical pharmacology data package at the time of an NDA submission? If the thought gives you "pre-test jitters," you might want to invest in a clinical pharmacology gap analysis -- a tool that can help you evaluate and address any potential gaps in your program before the FDA does.

The field of clinical pharmacology can help stakeholders address these challenges and improve decision-making at critical milestones, whether early in proof-of-concept phases (preclinical through 2a clinical trials) or in the later stages where a more robust risk and efficacy profile is established (2b through 3 clinical trials). The tools, methods, and frameworks (e.g., mechanistic or quantitative) of clinical pharmacology span distinct sub-specialties and can significantly impact these preclinical and clinical phases.

For more information about this complimentary session visit: Best Practices in Clinical Pharmacology Gap Analysis.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers..

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