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Happy Biotech

Happy Biotech

Von: Happy Biotech
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 Podcast by Happy BiotechAll rights reserved Wissenschaft
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  • From Molars to Metadata - TMF Tales with Pooja

    From Molars to Metadata - TMF Tales with Pooja
    Nov 17 2025
    Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
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    32 Min.
  • Conferencing Standards: From CDISC to Chicken & Waffles - Inside the push to standardize TMFs—and rediscovering the human side of biotech.

    Conferencing Standards: From CDISC to Chicken & Waffles - Inside the push to standardize TMFs—and rediscovering the human side of biotech.
    Oct 30 2025
    Micah returns to the conference world after twenty years, diving into the CDISC/TMF Interchange in Nashville. From acronyms to alignment debates, Suus and Micah unpack how the industry’s drive for standards collides with the messy, very human side of collaboration. Along the way: networking hacks, risk logs, Dutch “poldering,” and yes—chicken and waffles.
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    33 Min.
  • ICF: The Most Important Thing You’ll Never Read Twice

    ICF: The Most Important Thing You’ll Never Read Twice
    Oct 9 2025
    Micah and Suus unpack the informed consent form—what it is, why it exists, and how IRBs/ECs shape it—plus the new plain-language summary trend, vulnerable-population rules, translations, and version updates when protocols or safety data change. Short, readable, and actually useful… unlike most fine print.
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    29 Min.
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