Transcript Webinar on Matured/Established Products Regulatory Support Models

Matured/Established Products Regulatory Support
& Models
Matured products go through multiple decisions in Global organization like: Keep or
divest? Same teams or different teams to handle them? For regional support, who should pay?
and more. All these stemming from cost pressures in global markets and changing regulatory
environment. Whether you are part of the Regulatory group in an emerging/mid-size/large global
Biopharma organization with aging product portfolio or a Generic company with multiple
products whose licenses need to be maintained, do not miss this upcoming Webinar on Mature
Products.
Our speaker, Chand Sishta, Director Global Regulatory Sciences, Mature Products at BristolMyers Squibb will focus on current challenges and what the future holds for them. Some of the
points being covered are listed below:
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What is a mature/established product
How do health authorities view mature/established products
What challenges are encountered for these products in international markets
How does information gathered via regulatory intelligence impact these products
How do these Mature Products thrive when generics are available in marketplace
How to manage compliance effectively
About Our Speaker
Chand Sishta is currently Director, Global Regulatory Sciences, Mature Products at Bristol Myers Squibb Company located in Lawrenceville, NJ.
Chand received his Ph.D. from the University of British Columbia, Vancouver, B.C. in 1990 and
completed a Post-Doctoral Fellowship at Northwestern University from 1990 to 1992. He started
as a discovery scientist with Union carbide Corporation in Bound Brook, NI in 1992 and this role
led to significant interactions with large manufacturing plants. Consequently, he worked as a
FDA Regulatory Manager at Union Carbide. Chand then worked for Bristol-Myers Squibb from
2000 to 2005 as Quality Assurance for the development division of BMS located in New
Brunswick, NJ. From 2005 to 2011, Chand worked for Pfizer as Regulatory CMC located in
Peapack, NJ.
Website Link: http://www.makrocare.com/webinar-registration-maturedestablished-products-regulatory-support-models