Course Description

CMC Writing and Submission Strategies: A Global Regulatory Approach

October 10-11, 2019 (Please note date change: Previously October 7-8, 2019)
Edison, NJ

Course Offering 191010NJ1989
Course ID 1989

In-Person Course

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.

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.

Maximize Your Learning!
Attend this course and its Companion Course:
CMC Simulation: A Hands-on Approach to Global Marketing Applications
October 9, 2019 • Edison, NJ • Course ID #2634

View a sample of the upcoming CMC course.

Course Director
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).

Venue Information
ExitCertified (MicroTek partner facility)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey 08837
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.