Ishani Maharaj of Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.
|Articles|July 21, 2016
Secure Document workflows in Drug Development
Author(s)DocuSign
Intensified regulatory scrutiny of data and reporting has increased demand for authentication of documents used in bio/pharma development and manufacturing. Mollie Shields Uehling, CEO of SAFE-BioPharma an association working to provide high-assurance identity trust for cyber transactions, describes the role digital signatures can play in ensuring the integrity of documents used in drug development and manufacturing processes. The discussion includes applications for digital signatures in pharma research, development, and manufacturing; regulatory requirements for document authentication; and how digital signatures can improve document authentication and workflow within organizations and when collaborating with external partners.
Advertisement
Advertisement
Related to this article
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.
Jaenisch, Muraru, and Pandey join PharmTech's Cole to discuss FDA's generative AI paper, ARPA-H's SURPASS trials, and AI accountability.
Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 1
2
Manufacturing Intelligence: What FDA's Real-World Use Case Database Means for CMC
3
FDA Rare Disease Framework Puts CMC Review in Scope
4
PharmTech AI Pulse Check: AI Watermark Vulnerability
5