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CfPA-The Center for Professional Advancement, Burlingame, CA
May 18, 2016
Who Should Attend?
This workshop is intended for individuals responsible for R&D/technical writing/quality management of original NDAs/ANDAs/BLAs/MAAs/etc. 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 workshop. 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; B.Pharm., Ph.D., MBA, Merck & Co |
Cheenu Murti is Director, Global CMC Regulatory Affairs, Merck & Co., Rahway, NJ, USA and Adjunct Faculty, 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 preformulation, formulation development and technology transfer. He moved to CMC Regulatory Affairs in 2000 and held positions of increasing responsibility at Organon and Schering-Plough, including three years at N.V. Organon, Oss, The Netherlands. He has served as a member of cross-industry working groups on regulatory issues through PhRMA and the Innovation and Quality (IQ) Consortium and as Organon’s liaison with USP. He led global regulatory CMC teams internally and in collaboration with other major companies.
He has directly 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 a 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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Note: To achieve the maximum learning benefit, pre-workshop preparation documents activity will be available for completion. Participants are encouraged to register early toallow sufficient time to access and complete the necessary pre-work, which will be made available approximately 2 weeks prior to the start date.
Maximize Your Learning!
Attend this course and its Companion Course:
CMC Writing and Submission Strategies: A Global Regulatory Approach
May 16-17, 2016 • Burlingame, CA • Course ID #1989