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Novel NDA Filing Strategies

June 6-7, 2017 | Arlington, VA
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When a company files a New Drug Application (NDA) in the US for their new drug product, it is often a time consuming and costly process requiring careful preparation over many years with no guarantee of success. Then once approval has been received there is the small matter of needing to comply with all the regulations and laws set by the US government to market your product in the US.

So how can we speed up the review and approval process and ensure a faster time to market? This conference will look at novel NDA filing strategies and best practice for ensuring a speeded up review process and allowing for better communications between the sponsor and the agency.

This conference is focused on the growing vulnerability of corporate data and the growing and pervasive threat of data breaches. Highly-publicized breaches have occurred at a number of prominent organizations, including Sony, Target, JP Morgan Chase, and Home Depot, suggesting that no organization is safe from these kinds of attacks. The Data Breach Summit 2016 will not only share best practices on how to be proactive in securing a company’s data, it will also cover the different types of breaches to watch out for, the recovery process after one occurs, and feature examples from leading executives that have encountered such obstacles.

This is a not-to-be-missed event to learn how to effectively protect against data breaches, as well as respond in a time-efficient manner, recovery processes if a breach occurs, legal & regulatory concerns, and more— a comprehensive A-Z look at the topic.

Leading Industry Speakers

Networking Sessions

Senior Participants

Who Should Attend?

Regulatory professionals in the development, distribution, marketing and post-market surveillance drugs, medical and biotechnology products and other medical treatments.

Pricing

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Contact Us

For sponsorship/exhibition and attendee registration, please contact Mark Coulter on +1-646-604-2821 or at mcoulter@curtiscoulter.com.

To submit a speaker abstract for this or other future events please contact Simon Curtis on +1-646-604-2804 or scurtis@curtiscoulter.com for more information.

Registration

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