Regulatory Filing Strategies Summit 2015

Key Topics

• The implications of Breakthrough Therapy Designation and how to correctly file for it
• Current regulatory landscape for NDA/IND/ANDA filing strategy and optimize drug development timelines
• Maximize efficacy of accelerated approval submissions by developping clinical trial protocols and REMS
• How to avoid wasting resources on re-submitting and to demonstrate compliance to build a better relationship
• 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

Professionals from pharmaceutical, biotechnology and medical device companies, responsible for:

• Submissions
• Regulatory Affairs
• Product Development
• Medical Writing
• Manufacturing
• New Product Launch
• Distribution
• Clinical Trial Design
• Post-Approval Marketing
• Legal Counsel, IP and Patents
• Clinical Trials Design
• Clinical Trials Management
• Research and Development
• Clinical Trial Director/Clinical Operations
• Translational Medicine/Clinical Pharmacology
• Global Regulatory Affairs
• Oncology Clinical Development/Oncology Clinical Operations