Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your clinical trial strategy?
April 28, 2021
Preparing your market application and planning the lifecycle management of your development program is critical to moving your product through early-phase trials and achieving commercial success. Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your clinical trial strategy?
Register for this webinar to explore these and other product development subjects. We’ll also explore case studies from recent product approvals. Topics will include:
The importance of developing a risk evaluation mitigation strategy, especially if risk factors require limited product distribution
- Making post-approval product changes, such as switching manufacturers
- The expanding role of pharmacovigilance in identifying potential safety issues
Join expert speakers from Premier Research, Kristi Miller, Ph.D., Vice President, Regulatory Affairs, Regulatory Professionals; Christopher Hendry, Senior Director, Technical Services, Regulatory Professionals; and Lee McGuinness, Executive Director & Global Head of Pharmacovigilance and Medical Device Vigilance, in a live webinar on Wednesday, May 19, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Market Application and Life-Cycle Management: The Road to Commercial Success.
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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