Webinar on Matured/Established Products Regulatory Support Models

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(No Transcript)
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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 Bristol-
• Myers Squibb will focus on current challenges and
  what the future holds for them. Some of the
• points being covered are listed below
•   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

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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-reg
  istration-matured-established-products-regulatory-
  support-models