Search for tag: "efspi"

DAY 2 - Part 2: Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies

Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies Recording of part 2 of day 2 (December 15, 2022, 14:00-17:30 (CET)) focusing on the…

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DAY 2 - Part 1: Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies

Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies Recording of part 1 of day 2 (December 15, 2022, 14:00-17:30 (CET)) focusing on the…

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DAY 1 - Part 2: Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies

Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies Recording of part 2 of day 1 (December 8, 2022, 14:00-17:00 (CET)) focusing on the…

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DAY 1 - Part 1: Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies

Joint EFSPI & BBS virtual event Addressing intercurrent events: Treatment policy and hypothetical strategies Recording of part 1 of day 1 (December 8, 2022, 14:00-17:00 (CET)) focusing on the…

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7th EFSPI Basel_Short topic session & Closure

Short topic session Chairs: Uli Burger (Roche) & Armin Koch (U Hannover & EMA) Closure Kaspar Rufibach (Roche, local organizing and scientific committee)

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7 th EFSPI Basel_Role of statistics / quantitative science in regulatory decision-making

Role of statistics / quantitative science in regulatory decision-making. Chairs: Emmanuel Zuber (Novartis) and Benjamin Hofner (PEI) Talk 1 (15min): Aloka Chakravarty (FDA, virtual): Generating…

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7 th EFSPI Basel_Generalizability and external validity: How to generate evidence about a treatment effect?

Generalizability and external validity: How to generate evidence about a treatment effect? Chairs: Kaspar Rufibach (Roche) and Kit Roes (Radboud University Medical Center & EMA) Talk 1…

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7th EFSPI Basel_Regulators and HTA bodies for new designs in Europe - How to deal with different priorities, especially for new design types?

Regulators and HTA bodies for new designs in Europe - how to deal with different priorities, especially for new design types? Chairs: Christoph Gerlinger (Bayer) and Andreas Brandt (BfARM) Talk 1…

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7th EFSPI Basel_Postbaseline subpopulation analyses: Known to be improper, but frequently done. Can we fix them?

Postbaseline subpopulation analyses: Known to be improper, but frequently done. Can we fix them? Chairs: Mouna Akacha (Novartis) and Khadija Rantell (MHRA) Talk 1 (25min): Björn Bornkamp,…

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7th EFSPI Basel_Q&A on Regulator on "What happened in the last two years in regulatory and HTA landscape"

Q&A and discussion on Regulator on "What happened in the last two years in regulatory and HTA landscape" Chairs: Randi Gron (Novo Nordisk) & Eftychia-Eirini Psarelli (EMA)

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7th EFSPI Basel_Opening & Regulator on "What happened in the last 2 years in regulatory and HTA landscape"

Introductory Keynotes: Regulator on "What happened in the last two years in regulatory and HTA landscape" Chairs: Randi Gron (Novo Nordisk) & Eftychia-Eirini Psarelli (EMA)Talk 1…

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Joint EFSPI / BBS Seminar: HTA - 30th June 2020 - Panel Discussion

Joint EFSPI / BBS Seminar: HTA - 30th June 2020 - Panel Discussion

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