Q9(R1): The Next Frontier

Presentations

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