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  3. Globally Harmonized Specifications Workshop: Implementing A Patient-Centric Control Strategy
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pdf AUQUIER Vanessa - Challenges in Product Specifications with Asian Regulatory Authorities compressed ( pdf, 485 KB ) (103 downloads)
pdf CHARTON Emmanuelle - Global landscape of specification A EP perspective compressed ( pdf, 1.97 MB ) (98 downloads)
pdf FUNATO Keiko - Science and Risk based approaches to Specifications compressed ( pdf, 575 KB ) (104 downloads)
pdf GELLERMANN Gerald - How uncertainties for complex biologics can be addressed compressed ( pdf, 653 KB ) (100 downloads)
pdf ISHII WATABE Akiko - ICHQ6 review status compressed ( pdf, 877 KB ) (133 downloads)
pdf JOUBERT Marissa - A Clinical Impact of Attributes (CIA) Approach for developing clinically relevant specifications fo ( pdf, 1.35 MB ) (65 downloads)
pdf KAWAMATA Shin - QbD based CGT products and role of analytics compressed ( pdf, 3.40 MB ) (110 downloads)
pdf KRAUSE Phil - Summary of outcomes and key messages from previous meeting compressed ( pdf, 318 KB ) (104 downloads)
pdf MASAYO Takahashi - Strategy for Retinal Cell Therapy compressed ( pdf, 2.09 MB ) (101 downloads)
pdf MOUTERDE Benedicte & RIOU Patrice - Vaccines are Biologicals with Unique Specificities compressed ( pdf, 1.45 MB ) (57 downloads)
pdf NIE Daisy - Strategis for Defining Specifications in Autologous CT products compressed ( pdf, 435 KB ) (100 downloads)
pdf PRE RECORDING YAMAGUCHI Takahiro - Industry perspective compressed ( pdf, 300 KB ) (141 downloads)
pdf RIOU Patrice & MOUTERDE - Bénédicte Setting Specifications Impact of Regulatory Harmonization compressed ( pdf, 1.06 MB ) (107 downloads)
pdf SARKAR Kaushik - Specification consideration for CGT products and role of analytics KaushikSarkar NNDK Final compre ( pdf, 802 KB ) (94 downloads)
 

 

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