Specifics of Pharmaceutical development for global clinical trials-Chitra Sharma-08/29/2017 - 8:30am

Event Information
Event Topic: 
Specifics of Pharmaceutical development for global clinical trials
Event Date: 
08/29/2017 - 8:30am
Event Location: 
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale
Speaker Information
Event Speaker: 
Chitra Sharma
Event Speaker Title: 
Event Speaker Company: 
gCompliance, Inc.
Event Speaker Bio: 

Chitra Sharma has over 15 years of experience in pharmaceutical development of small and large molecules. Chitra founded gCompliance, Inc., with a vision to execute projects in pharmaceutical development to commercialization. She takes on projects that have process scale up / optimization needs and engages from start to finish i.e., from development to commercial product launch readiness. Her consulting firm strengthens internal resources in client organizations and provides product specific needs to create complete product portfolios. gCompliance, Inc. has clients ranging from virtual biotech to large pharmaceutical firms. 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 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 evolve currently run practices or processes. Even simple events like enrolment rate or the number of patients per country is data. Manufacturing is complex for these trials. Packaging and labeling has a whole different set of rules that are needed to be processes along the trial. 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.