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

  December 06, 2016  
CfPA-The Center for Professional Advancement, New Brunswick, NJ
November 8, 2017

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
November 6-7, 2017 • New Brunswick, NJ • Course ID #1989
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Course Director
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.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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