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Regulatory Filing Strategies Summit

  • Abbreviation: RFSS
  • Conference Type: Conference
  • Start Date: Monday February 23, 2015
  • Conference URL: http://atnd.it/17852-0
  • Hotel Venue: The Rittenhouse Hotel
  • Street: 210 West Rittenhouse Square
  • City: Philadelphia
  • State: Pennsylvania
  • Country: United States
  • Zip/Postal Code: 19103
  • Contact Email: ering@exlpharma.com
  • Contact Name: Evan Ring
  • Listed: December 13, 2014 10:15 pm
  • Expires: This ad has expired


Best Practices for Expedited Drug Approvals Through Competitive Positioning of New Drug Applications for Priority Review, Accelerated Approval, Fast Track Designation and Breakthrough Therapy.

The regulatory filing process can drain valuable time and resources when developing a drug for approval. As being the first to hit the market with a new drug therapy before their competition is a huge business advantage, speeding up the FDA approval process is the best route to position a therapy for maximum market share and to ensure people in need receive the highest quality treatment possible as quickly as possible.

The Regulatory Filing Strategies Summit is the only event in the industry that has been designed to help regulatory, submissions and legal professionals understand the ins and outs of each of these options and the criteria drugs must meet in order to file for these accelerated tracks, as well as how to compile that data and submit it for approval. This event provides hard case study evidence on which methods are best and debates which method is optimal for certain new therapies.

Conference – Early Bird Rate prior to 1/16/15: USD 1895
Conference – Standard Rate after 1/16/15: USD 2095
Conference – Onsite Pricing: USD 2195

Speakers: Richard Guarino, Validus Pharmaceuticals, Athena Chiladakis, Bayer, Nanitae Cranford, Jazz Pharmaceuticals, Chitra Edwin, Cleveland Heartlab, Janet Karlix, Elan Pharmaceuticals, Sophia Kourliouros, Eisai, Carlos Langezaal, Eisai, Stefan Ochalski, Johnson & Johnson, Jennifer Richards, Salix Pharmaceuticals, Andrew Storey, Abbvie, Ron Trust, Durata Therapeutics, Olga Alfieri, Eisai, Roger Warde, BioMarin Pharmaceuticals

Monday February 23, 2015 at 8:00 am to Tuesday February 24, 2015 at 5:00 pm

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Ad Reference ID: 6755476cddbe8e95

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