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CMC Writing and Submission Strategies: A Global Regulatory Approach

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Overview / Abstract:

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
• 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 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.


Jun 27, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

Shrinivas (Cheenu) Murti; B.Pharm., Ph.D., MBA, Merck & Co

Cheenu Murti is Director of Global CMC Regulatory Affairs at Merck & Co., Rahway, NJ, USA and adjunct faculty at the Philadelphia College of Pharmacy, 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 analytics, preformulation, formulation development, and technology transfer. He moved to Regulatory Affairs - CMC in 2000 and held positions of increasing responsibility at Organon and Schering-Plough, prior to Merck, including three years at N.V. Organon, Oss, The Netherlands. He also served as a member of the PhRMA eCTD working group and Organon’s liaison with USP, and has led global regulatory CMC teams internally and in collaboration with other major companies.

He has 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 an active 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.

Keywords / Search Terms

CfPA CMC, Regulatory, Chemistry, Manufacturing and Controls, Drug Master Files, Quality By Design (QbD), Scale-up, Technology Transfer Seminar CE CME

LIVE Activity Location Details

06-26-2018 - 06-27-2018

Amsterdam, The Netherlands

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