Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)

Graham Cook; Georges France; Øyvind Holte; Giampiero Lorenti; David Tainsh

doi:10.5731/pdajpst.2015.006171

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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)

Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti and David Tainsh

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 163-176; DOI: https://doi.org/10.5731/pdajpst.2015.006171

Graham Cook

1Pfizer UK, Farnham, Surrey, UK;

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For correspondence: graham.cook@pfizer.com

Georges France

2Novartis Switzerland, and GSK Switzerland, Prangins (Nyon), Switzerland;

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Øyvind Holte

3Norwegian Medicines Agency, Oslo, Norway;

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Giampiero Lorenti

4Italian Medicines Agency, Rome, Italy; and

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David Tainsh

5GSK UK, Brentford, Middlesex, UK

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1.↵
Joint European Medicines Agency/Parenteral Drug Association Quality-by-Design Workshop, London, 28–29 January 2014, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2013/12/event_detail_000808.jsp&mid=WC0b01ac058004d5c3

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PDA Journal of Pharmaceutical Science and Technology

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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)

Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti, David Tainsh

PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 163-176; DOI: 10.5731/pdajpst.2015.006171

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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)

Graham Cook, Georges France, Øyvind Holte, Giampiero Lorenti, David Tainsh

PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 163-176; DOI: 10.5731/pdajpst.2015.006171

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Keywords

Quality by Design (QbD)
European Medicines Agency (EMA) Workshop London 2014
Presentation of information
Submissions
Regulatory dossier
Development
Risk assessment
Criticality
Design space
Models
control strategy
Post-approval
lifecycle management
Quality System
Deviations

[1] 1.↵
Joint European Medicines Agency/Parenteral Drug Association Quality-by-Design Workshop, London, 28–29 January 2014, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2013/12/event_detail_000808.jsp&mid=WC0b01ac058004d5c3

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Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28–29 January 2014)

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Parenteral Drug Association, Inc.