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.
Top Five Reasons to Attend
Learn about the current regulatory landscape to better develop your NDA/IND/ANDA filing strategy and optimize drug development timelines
Gain firsthand knowledge from leading regulatory experts on the implications of Breakthrough Therapy Designation and how to correctly file for it
File in accordance with FDA Guidances to avoid wasting resources on resubmittals and to demonstrate compliance to build a better relationship
Develop clinical trial protocols and REMS to maximize efficacy of accelerated approval submissions
Network with peers to discuss the benefits and drawbacks to accelerated approval tracks and their impact on drug development and disease treatment since being introduced in the 1980s
Who Should Attend
This conference is of interest to professionals from pharmaceutical, biotechnology and medical device companies with responsibilities involving: