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Webinar: Biopharmaceutics Classification System (BCS)-based Biowaivers [1]

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Date: 2024-11-29

Join our Webinar on Biopharmaceutics Classification System (BCS)-based Biowaivers. This webinar aims to present the WHO guideline on Biopharmaceutics Classification System-based biowaivers (Annex 7, TRS 1052), emphasizing the main characteristics for the applicability of these biowaivers and establishment of in vivo bioequivalence, while comparing with previous requirements for BCS-based biowaivers. Moreover, the webinar will also present the WHO Biowaiver Project and The WHO Biowaiver List as a Tool to Reach Universal Health Coverage.

Key topics/issues

Introduction: Briefly introduce the purpose of the webinar and provide an overview.

Briefly introduce the purpose of the webinar and provide an overview. The WHO guideline on Biopharmaceutics Classification System-based biowaivers: Present the guideline and discuss the changes compared to the superseded section of the WHO Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 6, TRS 1003).

Present the guideline and discuss the changes compared to the superseded section of the WHO Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 6, TRS 1003). The WHO Biowaiver Project : Present the multicenter research project established by WHO to experimentally determine the equilibrium solubility profile of medicines listed in the WHO Model List of Essential Medicines using a harmonized approach.

: Present the multicenter research project established by WHO to experimentally determine the equilibrium solubility profile of medicines listed in the WHO Model List of Essential Medicines using a harmonized approach. The WHO Biowaiver List: Present the WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (Annex 6, TRS 1052) as a tool for national regulatory authorities and pharmaceutical manufacturing companies, suggesting products that are eligible for a waiver from in vivo bioequivalence studies.

Present the WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (Annex 6, TRS 1052) as a tool for national regulatory authorities and pharmaceutical manufacturing companies, suggesting products that are eligible for a waiver from in vivo bioequivalence studies. Q&A session: Allow time for participants to ask questions and provide feedback on the revised guideline.

Same content will be presented during both sessions, please register using one of the links below to attend at your preferred time.

For any issues, please contact [email protected] with a copy to [email protected].

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[1] Url: https://www.who.int/news-room/events/detail/2024/11/29/default-calendar/webinar--biopharmaceutics-classification-system-(bcs)-based-biowaivers

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