Documentation Drug Development Workshop 
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
pharmaphorum
FEBRUARY 3, 2022
Workshops: 29 April 2022. SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference is taking place in Boston on April 27-28, 2022, with interactive workshops on April 26, 2022. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.
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Putting Patients First Blog
AUGUST 15, 2024
hosted a series of workshops with patients, patient organizations, industry, and other stakeholders to develop a document known as the ‘Patient Experience Dossier’ (PED). In addition, patient experience data has also been included as part of the 21 st Century Cures Act which would assist the U.S.
Express Pharma
OCTOBER 19, 2024
Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D. References [link] [link] 281%29.pdf
FDA Law Blog: Biosimilars
AUGUST 23, 2023
This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.
Viseven
AUGUST 7, 2024
This will give you access to industry expert-led courses, scientific workshops, and mentoring opportunities. As most documents come in a PDF format, Adobe Acrobat is helpful for this task. Most importantly, you can form valuable professional relationships, learning from other writers’ mistakes and success stories.
Viseven
DECEMBER 13, 2024
Data collection involved paper forms, diaries, and in-person interviews , which, while essential for documenting symptoms and outcomes, were prone to human error. Maintaining regulatory compliance required extensive documentation and oversight, while handling paper-based data was labor-intensive and prone to mismanagement.
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