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CfPA-The Center for Professional Advancement, Burlingame, CA
May 16-17, 2016
Who Should Attend?
This course is intended for individuals responsible for R&D/technical writing/quality management/original and postapproval submissions in pharmaceutical companies, especially those in:
• Regulatory Affairs
• QA/QC
• Process Chemistry
• Analytical Chemistry
• Preformulation and Formulation Development
• Scale-up and Technology Transfer
Experience of one year or more in one of the above areas is recommended to fully benefit from this course.
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Shrinivas (Cheenu) Murti, Ph.D., MBA; Merck & Co. |
Cheenu Murti is Director of Global CMC Regulatory Affairs at Merck & Co., Rahway, NJ, USA and adjunct faculty at the Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA, USA. He has a B.Pharm. from the University of Bombay, India, a Ph.D. in Pharmaceutical Sciences from the University of Missouri and an MBA in General Management from Rutgers University.
Over a professional career spanning more than 20 years, Dr. Murti has worked in analytics, preformulation, formulation development, and technology transfer. He moved to Regulatory Affairs - CMC in 2000 and held positions of increasing responsibility at Organon and Schering-Plough, prior to Merck, including three years at N.V. Organon, Oss, The Netherlands. He also served as a member of the PhRMA eCTD working group and Organon’s liaison with USP, and has led global regulatory CMC teams internally and in collaboration with other major companies.
He has interacted with health authorities in the US, Canada and Europe and has developed global regulatory submission strategies and written submissions for drugs belonging to different therapeutic classes and dosage forms. Dr. Murti has been an active member of several professional associations over his career including AAPS, AAiPS, PDA, DIA and RAPS and given invited presentations in the US and in Europe.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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Maximize Your Learning!
Attend this course and its Companion Course:
CMC Simulation: A Hands-on Approach to Global Marketing Applications
May 18, 2016 • Burlingame, CA • Course ID #2634