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CfPA - The Center for Professional Advancement, Burlingame, CA
September 20-21, 2010
Who Should Attend
This course is intended for individuals responsible for R&D/technical writing/quality management/submissions in pharmaceutical companies, especially those in:
• Regulatory Affairs
• Process Chemistry
• Preformulation and Formulation Development
• Scale-up and Technology Transfer
• Analytical Chemistry
• QA/QC
Experience of one year or more in one of the above areas is recommended to fully benefit from this 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 applications in the US and Europe. Additional considerations and integrative approaches for submissions in Japan and other markets will be discussed. Emphasis will be placed on current FDA, EU and ICH guidelines for the CTD Quality section and will cover development, manufacturing (including sterilization), analytical, controls and stability issues. Successful regulatory filing strategies will be illustrated with examples and case studies. Overviews of Quality By Design (QbD) submissions, Drug Master Files and special requirements for biologics will be presented.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Shrinivas (Cheenu) Murti, Associate Director, Global Regulatory Affairs– CM; Schering-Plough Corporation
Shrinivas (Cheenu) Murti is Associate Director, Global Regulatory Affairs–CMC at Merck & Co., Kenilworth, NJ and Adjunct Associate Professor, Department of Pharmaceutical Sciences at the Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA. 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, 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 a number of global regulatory projects and 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 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 is currently co-developing a course on the application of regulatory science in pharmaceutical development at the University of the Sciences, Philadelphia.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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