Keep up with the latest news from CfPA, receive notifications about upcoming courses in your area of interest and more.
CMC Writing and Submission Strategies: A Global Regulatory Approach
October 10-11, 2019 (Please note date change: Previously October 7-8, 2019)
Course Offering 191010NJ1989
Course ID 1989
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
• 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.
Shrinivas (Cheenu) Murti; B.Pharm., Ph.D., MBA, Merck & Co
Shrinivas (Cheenu) Murti is Director, Global Regulatory Affairs–CMC at Merck & Co., Inc., Rahway, NJ, and adjunct faculty at the Philadelphia College of Pharmacy, University of the Sciences, Philadelphia. 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.
Prior to Merck, Cheenu worked at Organon and Schering-Plough, including three years in The Netherlands. He joined Regulatory CMC in 2000, after positions of increasing responsibility in pre-formulation, product development and technical operations. He has interacted with global health authorities on many topics of regulatory strategy and compliance, and has given invited presentations in the US, Europe and India.
Cheenu has been affiliated with several professional associations over his career and has served as a member of cross-industry working groups within AAPS, PhRMA, the IQ Consortium and ISPE, as also as Organon’s liaison with USP. He has developed and taught courses on CMC submissions and strategies in the US, The Netherlands, Spain and Turkey through CfPA since 2009, and lectured at several universities. He is a past President of the American Association of Indian Pharmaceutical Scientists (AAiPS).
ExitCertified (MicroTek partner facility)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey
Phone: 800-207-9620 (for directions and parking info only)
PLEASE NOTE: Participants must make their own reservations; the cost of
hotel accommodation is not included in the course fee. Final hotel information
will be emailed to you in your confirmation package approximately 3 weeks
prior to the course start date.
Directions: Visit the Hotel Venue topic on our FAQ page.