Q1 5th Annual Reg CMC: STRATEGIES TO PROVIDE COMPREHENSIVE CMC DATA FOR EXPEDITED APPROVAL PRODUCTS

Wed, Nov 13th 2019
San Diego, California
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Many pharmaceutical organizations strive to obtain expedited path- way designations for new products as this allows for quicker approval timelines and fast market launches; however, this can also greatly impact the clinical development processes.

While accelerated path- ways offer a variety of potential benefits for manufacturers, there is a great strain placed on CMC and developmental teams as oper- ational and submission timelines are severely condensed. The data compiled, analyzed and reported during CMC operations is vital to showcasing product safety and efficacy; therefore CMC executives are continually exploring avenues to streamline CMC processes that will not diminish the quality of CMC outcomes.

• Effect of expedited pathways on operational deadlines

• Streamlining processes to align with expedited timelines

• Lessons learned from expedited CMC data submissions

1:30 CASE STUDY ONE: Karin Pihel, Director CMC, RA ENZYVANT THERAPEUTICS

2:00 CASE STUDY TWO: Mallika Singh, Senior Director, CMC Project Management
INCYTE CORPORATION

2:30 EXPEDITED PRODUCT APPROVAL APPLICATIONS PANEL DISCUSSION
PANELISTS
:
Jason Birri, HALLORAN CONSULTING GROUP

Karin Pihel, ENZYVANT THERAPEUTICS Mallika Singhm, INCYTE CORPORATION

Resgistration:

Use code Q1CMC200 for $200.00 off!