Robert Sussman

Robert Sussman

Company: SafeBridge Regulatory & Life Sciences Group

Job title: Managing Director

Seminars:

Chairs Closing Remarks 3:15 pm

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day: Day Two

Panel Discussion: Manufacturing Quality, Operator Safety & Regulatory Considerations in Sterile HPAPI Production 9:35 am

• Is the application of negative (HPAPI) or positive (Sterile) pressure cascades most appropriate? • Design of engineering controls for sterile production and reduced cross contamination for quality assurance • Revisions to Annex 1 and surrounding regulatory landscape • Measuring product quality and operator safety in sterile HPAPI manufacturingRead more

day: Day Two

Opening Remarks 9:00 am

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day: Day Two

Panel Discussion: The Future of HPAPIs, Cost/Risk Analysis & Advanced Manufacturing 10:00 am

As pipelines become more potent, for which indications is costly single nanogram containment cost beneficial for? Contrasting rare disease and wide-spread indications How can we better target drugs to efficaciously apply HPAPI’s for patient benefit? • How are analytical cleaning methods affected, given very low (single particle like) concentrations won’t be distributed like a gas…Read more

day: Day One

Welcome & Chairs Opening Remarks 8:50 am

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day: Day One

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