Biotech Webinar 2011 - Strategies for implementation and compliance for Phase I Investigational Drug and Biologic products

Why Should You Attend:

cGMP guide lines were formulated for the purpose of regulating large-scale manufacturing and commercial drug products. But it is amended in 21 CFR Part 210 for applicability to small-scale laboratory production of exploratory and investigational drug and biologic products. The amended GMP guide lines are a component of the FDA’s “Product Quality for the 21st Century” initiative for a selective approach to varying production objectives during drug development. These exemptions allow the option to the FDA to advise investigators on the safety requirements of laboratory production lots that unequivocally permit administration to human subjects in clinical trials.

This webinar will provide a detailed overview of cGMP regulations for IND drug and biologic products. The applicable requirements from earlier FDA guidance documents will also be addressed. The key differences between cGMP regulations between IND and manufacturing production will be identified to enable streamlining the drug development process through the identification of new, innovative therapies. The comprehensive guidelines of regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.

In conclusion, this webinar will educate the participant on the broad ranging systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates, risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.

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