Preparing your market application and planning the lifecycle management of your development program are 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 trial strategy?
Watch this webinar to explore these and other product development subjects. We’ll also explore case studies from recent product approvals. Topics 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
- Kristi Miller, Ph.D., Vice President, Regulatory Affairs, Regulatory Professionals, a division of Premier Research
- Christopher Hendry, Senior Director, Technical Services, Regulatory Professionals, a division of Premier Research
- Lee McGuinness, Executive Director & Global Head, Pharmacovigilance & Medical Device Vigilance, Premier Research