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CMC Writing and Submission Strategies: A Global Regulatory Approach

  February 06, 2020  
CfPA- The Center for Professional Advancement, Amsterdam, The Netherlands
1-2 June, 2020

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.


Course Description
This course requires Prerequisite Online Training. See course outline for details.

The prerequisite online course provides the opportunity to examine the guidelines, directives and regulations of the key regulatory agencies including the FDA, EMA and ICH. By understanding the Common Technical Document (CTD) and supporting documents, participants will be ready to move into the intensive, in-person training with a clearer understanding of agency requirements.

The ICH Common Technical Document (CTD) is the basis of drug and biologic registration applications, and a proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval.

With the prerequisite complete, the 2-day, accredited, in person training will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications in the US, Europe and Japan. Additional considerations and integrative approaches for submissions in emerging markets (“Most of the World” countries/regions) will be discussed. Emphasis will be placed on current national and ICH guidelines, and special considerations for biologics will be discussed. Development, manufacturing, analytical testing, controls and stability issues will be presented for solids, parenterals and other dosage forms. Overviews of Quality By Design (QbD) submissions and Drug Master Files will be presented. Successful regulatory filing strategies and best practices will be illustrated with examples and case studies. 

Organized by: CfPA- The Center for Professional Advancement
Invited Speakers:
   Shrinivas (Cheenu) Murti; B.Pharm., Ph.D., MBA, Executive Director, Global Regulatory Affairs - CMC, Merck & Co

Shrinivas (Cheenu) Murti is Executive Director, Global Regulatory Affairs - CMC at Merck & Co., Kenilworth, NJ. 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: knee@cfpa.com
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