Strategies for Regulatory Starting Materials Designation in Drug Development and Manufacturing, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the speakers will discuss how RSM designation can mitigate regulatory risks and prevent unexpected cost rises. Attendees will learn the expectations of regulators on the scope of presentation of RSMs required in filings.

Xtalks Life Science Webinars

The speakers will also summarize several case studies where pharmaceutical/biotech CMC teams worked with outsourcing partners to design and execute strategies, enabling successful risk mitigation on RSM “push backs” for global filing.

Join Valdas Jurkauskas, PhD, VP of CMC, Akebia Therapeutics and Ke Chen, PhD, VP, Process Research & Development, WuXi STA, a WuXi AppTec Company, in a live webinar on Thursday, May 7, 2020 at 11am EDT (4pm BST/UK).

The selection of drug substance regulatory starting materials (RSMs) and justification of their designation in the pharmaceutical supply chain has become an industry-wide focus as a measure of mitigating regulatory risks, as well as preventing unexpected rises in cost when transitioning from clinical to commercial supply chains.

In this webinar, the speakers will discuss expectations of regulators on the selection of RSM and the justification of their designation in the pharmaceutical supply chain. In addition, the scope of presentation of RSMs required in regulatory filings and how to prepare for “push backs” in the event of a major objection to the sponsor’s RSM designation will be examined.

The speakers will also summarize several case studies where pharmaceutical/biotech CMC teams worked with outsourcing partners to design and execute strategies, enabling successful risk mitigation on RSM “push backs” for global filing.

For more information or to register for this event, visit Strategies for Regulatory Starting Materials Designation in Drug Development and Manufacturing.

ABOUT XTALKS

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.

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

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

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Sydney Perelmutter
Xtalks
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