From the Patient and Agency lens - Drug Development and Approval -Chitra Sharma-02/03/2015 - 8:30am

Event Information
Event Topic: 
From the Patient and Agency lens - Drug Development and Approval
Event Date: 
02/03/2015 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Speaker Information
Event Speaker: 
Chitra Sharma
Event Speaker Title: 
Technical Consultant
Event Speaker Company: 
Event Speaker Bio: 

Chitra Sharma is a Technical Consultant with over 15 years experience in pharmaceutical development of small and large molecules. Chitra has specific experience in late stage product development, quality and regulatory strategy areas. She takes on projects that need a strong analytical focus in Method Development and Validation, sets Quality policies that help stay in compliance and strengthens internal resources with product specific needs for Client organizations.
She has authored and reviewed submissions and led several inspections by US FDA, EMA, ANVISA, TFDA, K-FDA, Canadian, Russian Ministry and the Japanese Agency. She has trained and led PAI preparedness teams at client, CMO and partner sites, internationally. Chitra has worked with companies to get them inspection ready as facilities and sites, globally, and has also worked on solution focused Inspection responses and actions for outcomes such as “483” Observations, Warning letters. She also works on Quality investigations, Counterfeit investigations, Field Alerts and Product recalls routinely.
Chitra previously worked at Vivus, Genentech, Cor Therapeutics, Roche BioSciences and Boehringer Ingelheim. She holds a MS in Pharmaceutical Sciences from the University of Connecticut, Storrs, CT.

Event Details
Event Details: 

The Drug development process is ever evolving. Expectations that allow patient access to medicines are more stringent than ever. The last decade has seen significant changes to how we do business and more importantly, what the Agencies around the world expect from us, in conduct and in submissions.
A review of near misses, what it takes to get that drug to approval and more importantly, what it takes to maintain Quality and Compliance will be a focus.