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Sponsored Webcast: Overcome Friction in FDA Submission Processes (On Demand)

Members: $0 | NonMember: $50
NDAs and INDs shouldn't be hard. In this webcast, we will explore the value of centralized processes and workflow automation solutions that keep critical FDA submissions on track.


Whether it's an Investigational New Drug (IND) or New Drug Application (NDA), managing a document submission process that spans multiple departments can quickly become complicated, increasing the risk of missed deadlines and rejections from the US Food and Drug Administration (FDA). In this webcast, we will explore the common pitfalls of managing regulatory submissions with manual tools, share best practices for interdepartmental communication, and demonstrate the power of process automation.

Registration Fees & Deadlines

Members: $0|NonMember:$50

Learning Objectives

  • Best practices for interdepartmental communication for INDs and NDAs
  • Common pitfalls and mistakes of managing regulatory submissions with manual tools
  • The power of process automation for regulatory submissions

Who Should Attend?

  • Regulatory, clinical, and medical affairs leaders
  • Medical writers and clinical trial managers who work on regulatory submissions.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Leslie Cort

Alex Reinthal
Vice President of Product, BP Logix, Inc.