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CMC Simulation: A Hands-on Approach to Global Marketing Applications

 
  March 14, 2019  
     
 
CfPA-The Center for Professional Advancement, Iselin, NJ
October 9, 2019


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
This advanced, highly interactive course will take CMC submission training to the next level. This one-day workshop will allow participants to simulate steps involved in the creation of the CMC section (CTD Modules 2.3 and 3) of global marketing applications in a hands-on setting through guided role-playing and analysis of outcomes. The simulation will cover technical data collation, application of relevant regulatory guidelines, creation of a cohesive submission, and strategies during agency review. Case studies pertinent to NDAs/ANDAs/BLAs, MAAs and JNDAs will be used and include drug substance and oral and parenteral dosage forms. The simulation will conclude with an interactive discussion of the case studies in terms of best practices for critical thinking and informed decision-making to increase the chances of regulatory success.

Note: To achieve the maximum learning benefit, pre-workshop preparation documents activity will be available for completion. Participants are encouraged to register early to allow 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
October 7-8, 2019 • Iselin, NJ • Course ID #1989
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
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).

 


 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
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