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Guidebook for Drug Regulatory Submissions Form

Guidebook for Drug Regulatory Submissions Form

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um well welcome everybody um thank you for attending this vip case presentation um my name's nick i'm a first-year fellow at ucb in our global regulatory affairs department and i'm joined by helen if you want to introduce yourself yeah hi everyone my name is helen weinberg and i'm the first year regulatory affairs fellow at vertex pharmaceuticals in conjunction with northeastern university very excited to have everyone here i did not have this presentation as a student so very nice to get a background of what regulatory affairs is and hear from people who are doing it firsthand um so just some objectives um you know obviously we're going to go over regulatory affairs in general um what's going to be of particular interest is the regulations that we'll go over as well as you know some of the global regulatory authorities i'm sure most people are familiar with the fda but clearly there's other health authorities arou

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