Conférences  >  Sciences biologiques  >  Biotechnologie  >  États-Unis

ComplianceOnline

In this two half-day workshop conference you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.

phase appropriate gmp, fda gmp workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management, 505(b)(2) Products process Validation, ISO 9001:2015 QMS, Combination Products

Législation en médecine et pharmacologie,    Pharmacologie et développement des médicaments

Gordon Research Conferences (GRC)

Therapeutic Implications of Antibody Engineering and Design

Gordon Research Conferences (GRC)

Exploring Antibody Biology, Formats, and Applications

Keystone Symposia

Cancer Immunotherapy: Bridging Basic Research and Clinical Translation brings together immunologists, oncologists, bioengineers, and translational scientists to accelerate the next generation of cancer therapies. The meeting spotlights immune-based approaches spanning foundational discovery to clinical application, highlighting how insights from basic biology are reshaping cancer treatment. Program sessions showcase advances in checkpoint therapies, cellular and engineered immunotherapies, cancer vaccines, and tumor microenvironment, and emphasize how innate and adaptive immune responses can be harnessed and optimized to improve therapeutic outcomes.

Cancer, Immunotherapy, Oncology, Biomedical Engineering, Bioengineering, Therapeutics, Translational Research, Protein Engineering

Biologie moléculaire,    Cancérologie