ICH Q9(R1): The Next Frontier
Section 1: Preface and Keynotes
Balancing Quality Assurance & Innovation in Pharma
Emma Ramnarine
Section 2: Plenary Session
HPRA’S KEVIN O’DONNELL ON THE ICH Q9 REVISION AND CONSIDERATIONS FOR ITS IMPLEMENTATION
Kevin O'Donnell
Quality Reborn
Anders Vinther
Morning Panel Discussion
Alice Redmond and Aidan Harrington
Section 3: Parallel Tracks - Innovation and Digital
Introducing Research Collaboration and GMP Human Resource Development at Three Universities with GMP Laboratories in Japan
Shingou Sakurai, Osamu Hiruta, and Ryoko Naruse
Leveraging Advanced Analytics in the Pharmaceutical Industry
Patrick O'Sullivan
Section3 : Parallel Tracks - QRM and RBDM
Valerie Mulholland on Improving RBDM Effectiveness
Valerie Mulholland
Achieving Warranted Acceptance of Biotechnologies
Emily Grayek and Baruch Fischhoff
Section 3: Parallel Tracks - Pharma Workplace of the Future Track
Exploring the Role of Knowledge in the Pharma Workplace of the Future: An Interactive Workshop Exploring Culture, KM and OpEx
Stephanie Friedrichsen, Nuala Calnan (editor), and Martin J. Lipa
Section 4: IPQ
Industry/Regulator Dialogue on Knowledge Management is Intensifying in Wake of ICH’s Q12 Initiative
( IPQ )