Topic: “The Business Side of Regulatory Affairs “
Speaker: Patrick Lee, Senior Consultant, Navigant Consulting
Date and Time: Tuesday, Sept. 29, 2015, 8:30 am
Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
There is no registration or fee for morning meetings.

Topic Description
Regardless of your background, this presentation on regulatory affairs could provide useful and critical insights to your company and your personal career. The regulatory affairs function in business planning and operations have often been overlooked or underestimated, a position that can have disastrous outcome for an emerging medical product company. As a regulatory consultant, we often see the effects of companies failing to meet regulations and falls into non-compliance and finally FDA sanctions. And on the opposite end, when a company fails to receive timely approval of its product by all the appropriate competent authorities, the delay in time is a direct loss to the company in the form of opportunity costs. Understanding regulations and compliance is a critical step to forming a successful business strategy.
This presentation will present basic concepts and terminology in regulatory affairs, followed by a discussion on regulatory strategies. Discussion will include the topics of how to refine indications-for-use statement, developing a meaningful partnership strategy, understanding market expectations, and others. There are significant factors regulatory can make or break a business’ strategy. The presentation will be interactive and audience participation and questions are welcomed.