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Boston Convention and Exhibition Center

Jun 24, 2018 8:30 AM - Jun 24, 2018 12:00 PM

415 Summer Street, , Boston, MA 02210 , USA

#24: Preparing for a US FDA Advisory Committee Meeting

Instructors

Lisa  Peluso

Lisa Peluso

President, Double Elevation, United States

Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped 45+ teams prepare to present and defend their positions at FDA Advisory Committee meetings and EMA Oral Explanations. Lisa also creates and leads dynamic workshops to empower teams to communicate complex science with clarity.

Martha  Arnold, MBA

Martha Arnold, MBA

Principal, PharmApprove, a member of the NDA Group, United States

Martha Arnold has led over 50 Advisory Committee preparation and pre-submission strategy projects at PharmApprove and possesses over 30 years’ experience in facilitating marketing and regulatory communications for pharmaceutical firms. She works closely with clinical, regulatory, and scientific experts to move compounds through all stages of the product lifecycle. Martha received an MBA from the University of Chicago School of Business and a BA from the University of Virginia.

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