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CMC Writing and Submission Strategies: A Global Regulatory Approach

  January 14, 2014  
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
26-27 June 2014

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.

RAPS - Regulatory Affairs Professional Society This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Shrinivas (Cheenu) Murti, Ph.D., MBA; Merck & Co.

Cheenu Murti works in Global CMC Regulatory Affairs at Merck & Co., Kenilworth, New Jersey and is adjunct faculty at the Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, Pennsylvania. 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, New Jersey. Over a professional career spanning more than 20 years, he has worked in analytics, preformulation and formulation development, technology transfer and, since 2000, in regulatory affairs.

Prior to company mergers, Dr. Murti was Director of Regulatory Affairs at Organon/Schering-Plough in New Jersey. He has led global teams through the clinical trial application, product registration and postapproval phases. He co-chaired regulatory CMC teams on joint full development projects with Sanofi and Pfizer, leading to successful registration outcomes. His global experience includes three years working at N.V. Organon, Oss, The Netherlands, where he chaired the company's CTD maintenance team for drug product. He also served as a member of the PhRMA eCTD working group and Organon's liaison with USP. He has interacted with health authorities in the US, Canada and Europe and has developed global regulatory submission strategies 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, PDA, DIA and RAPS. His invited presentations include the AAPS Arden House Conference, NY and the University of Uppsala, Sweden. He co-teaches a graduate course in regulatory science at the University of the Sciences.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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