This course will cover the following topics:
• U.S. requirements and processes
• U.S. government oversight of diagnostics, diagnostic clearance and approval pathways
• Co-development process & timelines
• Integration of Rx and Dx development plans
• Navigating the development process
• Co-development examples and lessons learned
• Diagnostics regulation in the EU, Japan, China and other complex emerging markets
• Developing a successful CDx global regulatory strategy
• Next generation sequencing applications and implications
• Current regulatory pathways
• Overview of things to consider in developing NGS applications for clinical use
• NGS in companion diagnostics – roles of pharma and diagnostic partners
• Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.
• Maham Ansari, MS, RAC, Consultant, Strategic Regulatory Services OptumInsight (UnitedHealth Group)
• Melina Cimler, Vice President, Quality & Regulatory Affairs, Illumina, Inc.
For more information on Molecular Med TRI-CON's short courses and to register, visit http://bit.ly/
About Cambridge Healthtech Institute (http://www.healthtech.com)
CHI is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI's portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and CHI's Media Group, which includes news websites and e-newsletters including Bio-IT World and Clinical Informatics News.
About Molecular Med Tri-Conference (http://www.triconference.com)
The 21st International Molecular Medicine Tri-Conference is the industry's Preeminent Event on Molecular Medicine, focusing on Drug Discovery, Genomics, Diagnostics and Information Technology. Spanning six days this year, the Tri-Conference includes an expanded program that includes 6 symposia, over 20 short courses, and 15 main programs. For the first time in over 10 years we're bringing back a dedicated conference on sequencing. As many will recall this event's infancy was heavily devoted to the Human Genome Project and we are excited to reintroduce sequencing to this event.