Documents

  1. Conferences and Webinars
    2. »
  2. 2025
    3. »
  3. Globally Harmonized Specifications Workshop: Implementing A Patient-Centric Control Strategy
    4. »
  4. Slides

Folder Slides

Select Toggle Title Date
pdf AUQUIER Vanessa - Challenges in Product Specifications with Asian Regulatory Authorities compressed ( pdf, 485 KB ) (1045 downloads)
pdf CHARTON Emmanuelle - Global landscape of specification A EP perspective compressed ( pdf, 1.97 MB ) (1200 downloads)
pdf FUNATO Keiko - Science and Risk based approaches to Specifications compressed ( pdf, 575 KB ) (1709 downloads)
pdf GELLERMANN Gerald - How uncertainties for complex biologics can be addressed compressed ( pdf, 653 KB ) (1385 downloads)
pdf ISHII WATABE Akiko - ICHQ6 review status compressed ( pdf, 877 KB ) (3610 downloads)
pdf JOUBERT Marissa - A Clinical Impact of Attributes (CIA) Approach for developing clinically relevant specifications fo ( pdf, 1.35 MB ) (1514 downloads)
pdf KAWAMATA Shin - QbD based CGT products and role of analytics compressed ( pdf, 3.40 MB ) (1470 downloads)
pdf KRAUSE Phil - Summary of outcomes and key messages from previous meeting compressed ( pdf, 318 KB ) (1563 downloads)
pdf MASAYO Takahashi - Strategy for Retinal Cell Therapy compressed ( pdf, 2.09 MB ) (1098 downloads)
pdf MOUTERDE Benedicte & RIOU Patrice - Vaccines are Biologicals with Unique Specificities compressed ( pdf, 1.45 MB ) (1023 downloads)
pdf NIE Daisy - Strategis for Defining Specifications in Autologous CT products compressed ( pdf, 435 KB ) (1658 downloads)
pdf PRE RECORDING YAMAGUCHI Takahiro - Industry perspective compressed ( pdf, 300 KB ) (3843 downloads)
pdf RIOU Patrice & MOUTERDE - Bénédicte Setting Specifications Impact of Regulatory Harmonization compressed ( pdf, 1.06 MB ) (1097 downloads)
pdf SARKAR Kaushik - Specification consideration for CGT products and role of analytics KaushikSarkar NNDK Final compre ( pdf, 802 KB ) (1934 downloads)
 

 

IABS
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.