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United States
1
GMP Expectations for Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
20 Nov 2025 - 21 Nov 2025 • washington dc, United States
Organizer:
FDAMap
Abstract:
Is your team preparing for a Phase I or First-in-Man (FIM) study? Join our intensive workshop on “GMP for Phase I & FIM Studies” and gain critical insights into how to meet the quality and manufacturing standards expected by the U.S. Food & Drug Administration (FDA!) from day one.
Topics:
FDA, Clinical Trials, GMP, FDA Regulation, FDA Compliance
Event listing ID:
1682799
Related subject(s):
Regulation in Medicine and Pharmacology,    Translational Medicine, Clinical Trials
Event website:
https://www.fdamap.com/workshops/gmp-for-phase-i-and-fim-studies.html
2
Statistical Elements of Implementing ICH Quality Guidelines
03 Dec 2025 - 04 Dec 2025 • Virtual Seminar, United States
Organizer:
ComplianceOnline
Abstract:
This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.
Topics:
ICH Quality Guidelines seminar, Statistical Considerations seminar, ICH guidelines, pharmaceutical manufacture, biotech manufacture, statistical methods, ICH guidelines compliance, statistical methods tools, statistical methods templates, regression analysis, confidence intervals, tolerance intervals, appropriate sample size, risk probability, process characterization for design space, FDA regulatory requirements
Event listing ID:
1682687
Related subject(s):
Biotechnology,    Pharmacogenomics, Personalized Medicine
Event website:
https://www.complianceonline.com/statistical-elements-implementing-ich-guidelines-seminar-training-80018SEM-prdsm?channel=conference-service
3
Pep Talk: Protein Science & Production Week 2026
19 Jan 2026 - 22 Jan 2026 • San Diego, United States
Organizer:
CHI
Abstract:
Join a vibrant community of scientists, trailblazers, and industry leaders at PepTalk 2026, as we mark 25 years of accelerating breakthroughs in biotherapeutic discovery and development. Renowned as one of the most influential events in protein science, PepTalk is where fresh ideas ignite, collaborations flourish, and next-generation solutions take shape.

This year’s expanded agenda features symposia and conference tracks, covering protein expression, production platforms, lab automation for higher throughput, analytical characterization and preformulation strategies for novel modalities, antibody discovery and development, and new this year - expression and development of therapeutic peptides and miniproteins.

Contact:
Phone: [781.972.5400];     Email: chi@healthtech.com
Event listing ID:
1676839
Related subject(s):
Molecular Biology
Event website:
https://cii.dryfta.com/eid/370/pid/103
4
ASENT — ASENT 2026 Annual Meeting
16 Mar 2026 - 20 Mar 2026 • Bethesda, United States
Organizer:
American Society for Experimental Neurotherapeutics (ASENT)
Abstract:
ASENT's 2026 Annual Meeting is the premier neuroscience and neurotherapeutics conference where leaders from providers and prescribers, employers, investors, fast-growing startups, big pharma, policymakers, funders & innovation centers gather to improve the process of bringing neurotherapeutics to market.
Contact:
Phone: [8332731556];     Email: jessica@asent.org
Topics:
Neurology, Neurotherapeutics, Neuroscience, Biotech, Bioengineering, FDA, NIH, Drug Development, Pipeline Presentations
Event listing ID:
1666630
Related subject(s):
Neurology
Event website:
http://asent.org


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Last updated: 9 November 2025