How Do You Prepare for an FDA Advisory Committee Meeting? PharmApprove Hosts Tutorial at 2016 DIA Annual Meeting

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The leading consultancy will share best practices and “must avoids” in advisory committee preparation

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"Our expert support and coaching allows drug and device developers to clearly articulate the case for approval, and then focus on what’s really important – bringing new cures and treatments to patients.” -- Lisa Peluso, PharmApprove

PharmApprove – a member of the NDA Group and the leading strategic, regulatory, and scientific communications consultancy in the U.S. – will lead a tutorial on FDA advisory committee preparation at the 2016 DIA Annual Meeting. The session will take place on Sunday, June 26th at 1:00 p.m. at the Philadelphia Convention Center, during DIA’s 52nd Annual Meeting. PharmApprove has more than 15 years of experience preparing companies for advisory committee meetings, and boasts an over 85 percent success rate.

“We ensure that our clients are 100 percent prepared for all scenarios when they appear before the FDA,” explained Lisa Peluso, director of coaching and client engagement for PharmApprove. “We understand what it takes to make a winning case before an advisory committee, and how to avoid potential pitfalls. Our expert support and coaching allows drug and device developers to clearly articulate the case for approval, and then focus on what’s really important – bringing new cures and treatments to patients.”

Peluso will lead the tutorial, which was developed with support from PharmApprove Founder and Executive Communications Strategist, Pete Taft. The tutorial helps corporate executives and other professionals across all R&D disciplines to effectively prepare for successful advisory committee meetings. PharmApprove has led thousands of training workshops and coaching sessions for regulatory, Medical Science Liaison, business development and payer negotiation teams at pharmaceutical companies around the world.

“When PharmApprove merged with NDA Group a few months ago, it heralded a truly exciting time for the company, with expanded global reach, expertise and talent. But that’s only one part of the equation,” said Laurie Smaldone MD, COO/CSO of NDA Group. “Our experienced coaching team and unsurpassed advisory committee preparation practices remain our strongest assets, allowing us to continue offering the best FDA approval consulting in the business.”

Visit http://dia201652ndannualmeeting.sched.org/event/61Nm for registration and scheduling information about the upcoming tutorial. Follow the social conversation online with the hashtag #DIA2016.

About PharmApprove
PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. PharmApprove merged with NDA in March of 2016. Learn more at pharmapprove.com or ndareg.com/pharmapprove and follow them socially at twitter.com/pharmapprove and facebook.com/pharmapprove.

About NDA
NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services incorporate regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. Clients are supported by a team of over 100 consultants and a unique Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. For more information, visit ndareg.com.

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Rachel Darwin
@taftandpartners
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