COURSE ID 1989

CMC Writing and Submission Strategies: A Global Regulatory Approach

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2150
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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

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.

This 12- hour accredited training ON DEMAND (with included prerequisite online course), will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and post approval 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 regional and ICH guidelines, and special considerations for biologics and combination products will be discussed. Development, manufacturing, analytical testing, controls, and stability issues will be presented for solids, parenteral 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.

This course is intended for individuals responsible for R&D/technical writing/quality management/original and post approval submissions in pharmaceutical companies, especially those in:
– Regulatory Affairs
– QA/QC
– Process Chemistry
– Scale-up and Technology Transfer
– Preformation and Formulation Development
– Analytical Chemistry

course instructor

Shrinivas (Cheenu) Murti, Ph.D.
MBA; Executive Director, Global Regulatory Affairs - CMC, Merck & Co.

Shrinivas (Cheenu) Murti, Ph.D.’s Courses
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 Cobblestone since 2009, and lectured at several universities. He is a past President of the American Association of Indian Pharmaceutical Scientists (AAiPS).