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| Brief about the Show: |
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| Designing and creating an stable nano particle, sterilisation, scalability and regulatory clearances for commercialisation of nanomedicines are big challenge areas for generic and biopharma companies. Designing and creating an stable nano particle, sterilisation, scalability and regulatory clearances for commercialisation of nanomedicines are big challenge areas for generic and biopharma companies. |
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Who Should Visit?
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R&D professionals |
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Formulations professionals |
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Regulations professionals |
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Engineering |
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Commercialisation |
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Important Topics
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Network with senior-level decision makers with extensive expertise and multiple publications on nano technology |
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Case study examples on documentation, clinical trials and licensing challenges when filing for new product approval to the European regulatory board |
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Validating predictive techniques for surface characterisation and adopting best practices to meet QBD standards |
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Understanding the chemistry, manufacturing and controls specifications critical for FDA regulatory approval |
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Evaluating most suitable technique for particle selection and polymorphic characterisation to increase bioavailability of pure drug nano molecule |
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Enhancing drug formulations of challenging complex drugs to achieve increased solubility and improved efficiency for nano medicines |
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Benefits Of Visiting
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Maintaining a minimum zeta potential of +(-)20mV by using stabalisers including cellulosics, poloxamer, polysorbates, lecithin, polyoleate and povidones for efficient stabalisation of nanosuspensions . |
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Using latest techniques to prevent compound crystals from converting into amorphous substance when homogenizing. |
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Examining the particularly challenging documentation procedure and understanding critical pre-requisites when filing for new Nano medicine product in the European market. |
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Developing harmonised licensing guidelines for approved nano medicines. |
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Checking the tensile strength, charge and particle size of nano particle to ensure complete coating and stability . |
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Quantitative characterisation of nano-drug delivery systems intended for intracellular targeting. |
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Carrying out field emission microscopy (FEM) in composite nanoparticles to investigate molecular surface structures and their electronic properties . |
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Selection of critical micro particles and crystals having similar physical properties to increase particle solubility. |
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Meeting the stabilisation challenges of poorly water soluble compounds by using liposomes, emulsions, microemulsions, solid dispersions and cyclodextrins . |
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Other Highlights
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Host of national and international experts discussing case studies of commercially launched products . |
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Representation from international regulatory bodies providing step-by-step guidance on your documentation and filing challenges Submit your case specific queries when registering and our expert speakers will surely provide clarifications. |
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Dedicated workshop to provide in-depth and practical solutions to your sterilisation and scalability challenges. |
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Network with senior-level decision makers with extensive expertise and multiple publications on nano technology. |
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Welcome to
IndianPharma.in
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