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Regulatory Filing Strategies Summit

23 - 24 February 2015, Philadelphia, United States


Introduction
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.

Useful links

Speakers
  • Richard Guarino Validus Pharmaceuticals, United States
  • Nanitae Cranford Jazz Pharmaceuticals, United States
  • Chitra Edwin Cleveland Heartlab, United States
  • Janet Karlix Elan Pharmaceuticals, United States
  • Sophia Kourliouros Eisai, United States
  • Carlos Langezaal Eisai, United States
  • Stefan Ochalski Johnson & Johnson, United States
  • Jennifer Richards Salix Pharmaceuticals, United States
  • Andrew Storey Abbvie, United States
  • Ron Trust Durata Therapeutics, United States

Venue
The Rittenhouse Hotel

The Rittenhouse Hotel, 210 West Rittenhouse Square, Philadelphia, 19103, United States

Organised by
ExL Pharma
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