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  11. AUQUIER Vanessa – Challenges in Product Specifications with Asian Regulatory Authorities compressed

pdf AUQUIER Vanessa – Challenges in Product Specifications with Asian Regulatory Authorities compressed

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14_AUQUIER Vanessa_Challenges in Product Specifications with Asian Regulatory Authorities_compressed.pdf

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  11. CHARTON Emmanuelle – Global landscape of specification A EP perspective compressed

pdf CHARTON Emmanuelle – Global landscape of specification A EP perspective compressed

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20_CHARTON Emmanuelle_Global landscape of specification – A EP perspective_compressed.pdf

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  11. FUNATO Keiko – Science and Risk based approaches to Specifications compressed

pdf FUNATO Keiko – Science and Risk based approaches to Specifications compressed

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10_FUNATO Keiko_Science and Risk-based approaches to Specifications_compressed.pdf

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  11. GELLERMANN Gerald – How uncertainties for complex biologics can be addressed compressed

pdf GELLERMANN Gerald – How uncertainties for complex biologics can be addressed compressed

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12_GELLERMANN Gerald_How uncertainties for complex biologics can be addressed_compressed.pdf

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  11. ISHII WATABE Akiko – ICHQ6 review status compressed

pdf ISHII WATABE Akiko – ICHQ6 review status compressed

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6_ISHII-WATABE Akiko_ICHQ6 review status_compressed.pdf

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  11. JOUBERT Marissa – A Clinical Impact of Attributes (CIA) Approach for developing clinically relevant specifications fo

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13_JOUBERT Marissa_A Clinical Impact of Attributes (CIA) Approach for developing clinically relevant specifications fo.pdf

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  11. KAWAMATA Shin – QbD based CGT products and role of analytics compressed

pdf KAWAMATA Shin – QbD based CGT products and role of analytics compressed

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27_KAWAMATA Shin_QbD-based CGT products and role of analytics_compressed.pdf

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  11. KRAUSE Phil – Summary of outcomes and key messages from previous meeting compressed

pdf KRAUSE Phil – Summary of outcomes and key messages from previous meeting compressed

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4_KRAUSE Phil_Summary of outcomes and key messages from previous meeting_compressed.pdf

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  11. MASAYO Takahashi – Strategy for Retinal Cell Therapy compressed

pdf MASAYO Takahashi – Strategy for Retinal Cell Therapy compressed

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3_MASAYO Takahashi_Strategy for Retinal Cell Therapy_compressed.pdf

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  11. MOUTERDE Benedicte & RIOU Patrice – Vaccines are Biologicals with Unique Specificities compressed

pdf MOUTERDE Benedicte & RIOU Patrice – Vaccines are Biologicals with Unique Specificities compressed

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11_MOUTERDE Benedicte & RIOU Patrice_Vaccines are Biologicals with Unique Specificities_compressed.pdf

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  11. NIE Daisy – Strategis for Defining Specifications in Autologous CT products compressed

pdf NIE Daisy – Strategis for Defining Specifications in Autologous CT products compressed

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24_NIE Daisy_Strategis for Defining Specifications in Autologous CT products_compressed.pdf

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  11. PRE RECORDING YAMAGUCHI Takahiro – Industry perspective compressed

pdf PRE RECORDING YAMAGUCHI Takahiro – Industry perspective compressed

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7_PRE-RECORDING_YAMAGUCHI Takahiro_Industry perspective_compressed.pdf

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  11. RIOU Patrice & MOUTERDE – Bénédicte Setting Specifications Impact of Regulatory Harmonization compressed

pdf RIOU Patrice & MOUTERDE – Bénédicte Setting Specifications Impact of Regulatory Harmonization compressed

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21_RIOU Patrice & MOUTERDE Bénédicte_Setting Specifications – Impact of Regulatory Harmonization_compressed.pdf

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  11. SARKAR Kaushik – Specification consideration for CGT products and role of analytics KaushikSarkar NNDK Final compre

pdf SARKAR Kaushik – Specification consideration for CGT products and role of analytics KaushikSarkar NNDK Final compre

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25_SARKAR Kaushik_Specification consideration for CGT products and role of analytics – KaushikSarkar_NNDK_Final_compre.pdf

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