Canadian Life Sciences Database

The Journey to Approval: Navigating the Road from EoP2 to NDA Submission, Upcoming Webinar Hosted by Xtalks

In this webinar, learn about the critical steps to new drug application (NDA) submission after completion of phase II studies. Attendees will gain insights into recommended timelines for key activities and key considerations for late-stage NDA strategy, including nuances for oncology therapeutics. The speaker will also share real-world examples of challenges in preparing for NDA submission and potential solutions to those challenges.

TORONTO, Sept. 9, 2024 /PRNewswire-PRWeb/ -- The transition from end of phase II (EoP2) to new drug application (NDA) submission is a complex and critical period in bringing new therapies to patients. For sponsors, this stage of development involves juggling challenges across multiple disciplines, from regulatory, nonclinical, and chemistry, manufacturing and controls (CMC) to quality, clinical and commercial.

Successful execution of this playbook requires a clear understanding of timelines and careful coordination across disciplines, as well as the ability to troubleshoot issues as they arise on a real-time basis.

Putting a well-planned NDA playbook in place ensures that all prerequisite pre-filing activities are completed and that the documents and data necessary for submission have been collected in the appropriate formats. Successful execution of this playbook requires a clear understanding of timelines and careful coordination across disciplines, as well as the ability to troubleshoot issues as they arise on a real-time basis.

In this webinar, Fedra Molaie-Holagh, Vice President of Regulatory Affairs, will discuss key considerations across the core drug development disciplines for developing a comprehensive NDA strategy and explore opportunities for streamlining the path from EoP2 to NDA submission.

Register for this webinar today to understand how new therapies can be developed by streamlining the path from EoP2 to NDA submission.

Join Fedra Molaie-Holagh, Vice President, Regulatory Affairs, Premier Consulting, for the live webinar on Tuesday, September 24, 2024, at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit The Journey to Approval: Navigating the Road from EoP2 to NDA Submission.

ABOUT XTALKS

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

To learn more about Xtalks visit https://xtalks.com

For information about hosting a webinar visit https://xtalks.com/why-host-a-webinar/

Media Contact

Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com, https://xtalks.com

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