Overview of the biotech drug development pathway

This webinar offers an overview of the multidisciplinary (CMC, non-clinical and clinical) requirements for the development of biotech products, outlines the regulations, highlights critical requirements and summarizes common CMC pitfalls and how to avoid them.

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ClinPHLEX – A Strategically-Focused, Cross-Functional, Clinical Development Partnership

ClinPhlex is a global, cross-functional, clinically-focused team that works in close collaboration with a client to  provide innovative, customized, efficient, strategic and tactical solutions to optimize and de-risk development. Our expertise and global experience in clinical development, clinical-regulatory strategy, biostatistics and biostatistical regulatory strategy, clinical and translational pharmacology as well as clinical research/operations and program management allow ClinPhlex to evaluate and improve your current position.

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Environmental Risk Assessments for Human Medicinal Products – Challenges and Recent Developments

Dr. Angela Vogt-Eisele, Senior Manager Scientific Affairs, Pharmalex will give you a clear overview on Environmental Risk Assessments for Human Medicinal Products especially about Challenges and Recent Developments.

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Understanding the Regulatory Landscape for Tissue, Cell and Gene Therapy Development

Dr. Buljovcic is a Biologist and has 15 years of experience working in the Regulatory Affairs business, including 10 years specializing in Tissue, Cell and Gene therapies.

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Optimize your biosimilar development strategy

Zeb Younes has over 16 years´ of experience in biopharmaceutical / biosimilar development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience in process development, purification, formulation, method development, characterisation, validation, comparability, release and stability testing.

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