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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vol. 70 no. 2 163-176

DOI

https://doi.org/10.5731/pdajpst.2015.006171

PubMed

26797977

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online April 13, 2016.

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previous version (January 21, 2016 - 17:53).
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Author Information

Graham Cook1,*,
Georges France2,
Øyvind Holte3,
Giampiero Lorenti4 and
David Tainsh5

¹Pfizer UK, Farnham, Surrey, UK;
²Novartis Switzerland, and GSK Switzerland, Prangins (Nyon), Switzerland;
³Norwegian Medicines Agency, Oslo, Norway;
⁴Italian Medicines Agency, Rome, Italy; and
⁵GSK UK, Brentford, Middlesex, UK

↵* Author for Correspondence: Dr. Graham Cook, 12 Greenhill Way, Farnham, Surrey, GU9 8SY, UK; e-mail graham.cook{at}pfizer.com; telephone +44-7717-878781

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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
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