Search Results for QbD

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ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer - Published 16 May 2017

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality

Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD

EMA-FDA QbD Pilot Program Led to Further Harmonization By Zachary Brennan - Published 19 April 2017

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: QbD pilot, EMA-FDA joint program, quality by design

US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines Published 06 March 2014

Categories: US, EMA, FDA

Tags: QbD Pilot Program, Quality-by-Design, Latest News, QBD, EU

EMA, FDA Publish New Guidance on Adhering to Quality by Design Principles By Alexander Gaffney, RF News Editor - Published 04 November 2013

Categories: US, EMA, FDA, ICH, Quality

Tags: Latest News, Quality by Design, QBD, guidance, EU

EMA, FDA Provide First Glimpse into Quality by Design Parallel Assessment Pilot By Alexander Gaffney, RF News Editor - Published 21 August 2013

Categories: US, EMA, FDA

Tags: QBD, EU