PLEASE NOTE That Chitra Sharma’s talk will begin at 8:45 AM, 15 minutes earlier than normal.  

Event Information

Event Topic:
Role of drug substance attributes on final approval of a marketed product

Event Description:
The globalization of clinical trials has been a regulatory strategy to increase patient participation, awareness in the medical community, cost savings and a single point of data collection to get global approvals from regulators worldwide. The semantics dictate that these applications themselves be split into NDA, MAA and such but the data can be utilized to foster drug approvals for the entire population, all at once. Execution of any regulatory strategy or one that involves multiple countries i.e. multiple regulators does bring in many challenges and opportunities to the pharmaceutical ingredient(s). Manufacturing is complex for these trials and attributes of the actual pharmaceutical ingredients - active and excipients or raw materials make a huge impact. This talk will attempt to touch upon the various factors that one needs to be taking into account and attributes of drug development that need to be understood for execution of a global clinical trial successfully. Actual cases without identity disclosure to be discussed.

Date/Time:
Date(s) - 08/25/20
8:30 am - 10:30 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/85043660945: Webinar

Speaker Information

Event Speaker:
Chitra Sharma

Event Speaker Title:
Founder, CEO

Event Speaker Company:
gCompliance, Inc

Event Speaker Bio:

Chitra Sharma has over 15 years of experience in pharmaceutical development of small and large molecules. In 2011, Chitra founded gCompliance, Inc., with a vision to execute projects in pharmaceutical development to commercialization. gCompliance, Inc takes on processes to scale up, meet optimization needs. gCompliance, Inc engages in early phase tiered development processes and takes them to launch. Her consulting firm has strong collaborations with industry resources. There is a concerted effort to strengthen internal resources and product specific requirements to build robust product portfolios for client organizations. gCompliance, Inc. has clients ranging from virtual biotech to large pharmaceutical firms, globally. 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

Cost:
$0

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