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TRANSCRIPT
Global Regulatory Summit Zürich, Switzerland
| www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg, MD 20879
Email: [email protected] | Phone: 410-501-5777 | (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.
Global Regulatory Summit Zürich, Switzerland
| www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg, MD 20879
Email: [email protected] | Phone: 410-501-5777 | (C) Copyright (2015) All Rights Reserved
Day 1: Key Sessions
8:30 – 9:00 AM: Registration Process
9:00 – 10:30 AM: Session 1: Kinds of FDA Meetings: Understanding FDA Meetings Speakers: Mukesh Kumar, Olga Pavlova 10:30 – 11:00 AM: Break
11:00 – 12:30 Noon: Session 2: Deciding When to Meet Authorities
Speakers: Mukesh Kumar, Beate Schmidt 12:30 – 1:30 PM: Lunch
1:30 – 3:00 PM: Session 3: Strategy for an FDA Meeting
Speakers: Mukesh Kumar, Daniela Drago 3:00 – 3:30 PM: Break 3:30 – 5:00 PM: Session 4: Meeting Information Package - FDA and EMA requirements Speakers: Mukesh Kumar, Olga Pavlova
5:00 – 6:00 PM: Networking reception
Day 2: Key Sessions 9:00 – 10:30 AM: Session 5: Practical Considerations for Meetings with Regulators Speakers: Mukesh Kumar, Kazem Kazempour 10:30 – 11:00 AM: Break 11:00 – 12:30 Noon: Session 6: Dispute Resolution Meeting, Audit Meetings Speakers: Salma Michor, Mukesh Kumar 12:30 Adjourn
View Detailed Agenda | Register as a Group and Save | FDAmap.com | Forthcoming Workshops
Special Registration Rates are Available for Multiple Attendees
Get 40% Discount For Multiple Registrants
For registrations, please contact us at:
Email: [email protected] or Phone: 410-501-5777
Olga Pavlova, PhD, Regulatory and Scientific Analyst
Amarex Clinical Research, USA
Washington D.C. Metro Area
Speakers