Global Regulatory Summit Zürich, Switzerland www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg, MD 20879 Email: [email protected] | Phone: 301-760-4952 | (C) Copyright (2015) All Rights Reserved Regulatory Consultations – Effective Interactions with US FDA in Comparison to European Authorities to Accelerate Global Drug Development Crowne Plaza, Zürich, Switzerland | 28-29 May, 2015 A Two Day Conference for Pharma and Device Industry Professionals Who will benefit Drugs, biologics, medical devices and diagnostic kits developers, who are planning to meet regulators or need tips on how to get the most out of a meeting with regulators. Salient features An opportunity to learn the agency’s perspectives on how to properly interact and what their expectations are during teleconferences and meetings The speakers will provide examples and case studies of best practices as well as common pitfalls in industry- agency interactions resulting in delays and denials Our panel of speakers includes experts, who are familiar with regulators’ perspective on adequate meetings Encapsulated information at one place Step-by-step instructions on creating a meeting- information-package / briefing book Extras Templates of briefing-book. Free one hour one-on-one consultation with US FDA experts on FDA meetings to first 10 requests from attendees on a first-come-first-serve basis. Handouts from all presentations. Free audio recordings for several sessions for future reference.