Q9(R1): The Next Frontier
Presentations
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Advantages of Modern Manufacturing for Patients, Industry, and Regulators |
Plenary Session | Rick Friedman | Download |
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Continuous Improvement in Pharma – Contradict or Complement to Compliance? |
Plenary Session | Thomas Friedli | Download |
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Pharma Workplace of the Future |
Pharma Workplace of the Future | Nuala Calnan, Stephanie Friedrichsen | Download |
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Achieving Warranted Public Acceptance of Biopharma Innovations |
QRM and RBDM | Baruch Fischhoff, Emily Grayek | Download |
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The Long Road to ICH Q12 |
QRM and RBDM | Jean Louis Robert | Download |
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Improving RBDM Effectiveness – Linking Knowledge, Risk, and Decision Making |
QRM and RBDM | Valerie Mulholland | Download |
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Risk Based Decision Making – using knowledge of risk throughout the lifecycle |
QRM and RBDM | Michael Schousboe | Download |
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Initiatives of Research Collaboration and GMP Human Resource Development at Three Universities with GMP Laboratories in Japan |
Innovation & Digital Transformation | Osamu Hiruta, Ryoko Naruse, Shingo Sakura | Download |
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The Practicalities of Digitalizing KM to Enable Data Driven QRM |
Innovation & Digital Transformation | David Twohig | Download |
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Leveraging Advanced Analytics in the Pharmaceutical Industry |
Innovation & Digital Transformation | Patrick O'Sullivan | Download |
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Data-Driven Risk Management |
Innovation & Digital Transformation | Pedro Ferriera | Download |
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Update on Innovation – Quality Innovation Group and ICH GCP E6(R3) |
Plenary Session | Peter Twomey | Download |
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Quality Reborn |
Plenary Session | Anders Vinther | Download |
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ICH Q9R1 Version – with Changes |
Plenary Session | Kevin O'Donnell | Download |
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ICH Q9(R1) and some personal thoughts about implementing the new guidance |
Plenary Session | Kevin O'Donnell | Download |
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Balancing Quality Assurance & Innovation in Pharma |
Keynote | Emma Ramnarine | Download |
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Smart Missions that Enable Innovation in High Risk Environments |
Keynote | Ed Hoffman | Download |