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Science & Risk Based Stability Practices in Pharmaceutical Development Part IV: Regulatory Landscape

Science & Risk Based Stability Practices in Pharmaceutical Development Part IV: Regulatory Landscape

February 24, 2022

Webinar

Location: Virtual

Venue: GoToWebinar

Register for this Event

Science & Risk Based Stability Practices in Pharmaceutical Development Part IV: Regulatory Landscape

Thu, Feb 17, 2022 11:00 AM - 12:00 PM EST

Presented by the Science & Risk Based Stability Working Group
Sponsored by the Analytical Leadership Group

Speakers

Current stability guidelines for development and registration do not specifically recognize stability strategies beyond traditional long-term studies. Guidelines sometimes indicate that alternative strategies may be used where justified. This webinar will discuss recent advancements in addressing these regulatory "grey zones". Case studies will be presented that focus on how companies have presented alternate strategies within regulatory submissions and discuss how these strategies were received. The case studies will span all stages of development.

The following learning opportunities will be discussed during this session:

This webinar is open to the general public. Membership in the IQ Consortium is not required for registration.