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CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
19-20 September 2016
Who Should Attend?
This course is intended for those who want to improve their understanding of the overall process of developing specifications for drug substance and drug products from generic, OTC and research-based pharmaceutical industries. The course includes both basic and advanced level topics of interest to:
• Pharmacists
• Analytical and Pharmaceutical Chemists
• Staff from Chemical Production Departments
• QA and QC Professionals
• Regulatory Affairs Personnel
• Pre-Clinical Scientists Course Description
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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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| Ernest Parente, Ph.D.; Sr. Principal Analytical Chemist, Mallinckrodt Pharmaceuticals |
Ernest Parente, Ph.D. is Senior Principal Analytical Chemist in the Product Lifecycle and Compliance Support group at Mallinckrodt Pharmaceuticals in St. Louis. Formerly, he was the Head of Analytical Science and the Director of Quality Control at Sanofi-Aventis in Kansas City. In addition to his experience in Quality, Dr. Parente has more than 18 years of experience in Research and Development and was the analytical chemistry team leader for the development of several currently marketed products. Before joining Sanofi-Aventis in 1989, he held positions in analytical and pharmaceutical R&D at Wyeth Laboratories, Warner-Lambert and Hoffmann-La Roche. He has served at the USP for over 15 years and is currently a member of the USP Council of Experts. Dr. Parente holds a Ph.D. in Analytical Chemistry from the University of Delaware. He is an Adjunct Assistant Professor in the Graduate School of Pharmacy at the University of Missouri-Kansas City and is an active member of the ACS, Sigma Xi, AAAS and AAPS. He is the author of scientific papers on chemical separations and protein analysis and has presented numerous U.S. and International lectures on topics related to pharmaceutical analysis and the pharmaceutical industry. | John Michael Morris, Ph.D. |
John Michael Morris, Ph.D. was Director Scientific Affairs at the Health Products Regulatory Authority (HPRA) of Ireland, in Dublin, Ireland until his retirement at the end of 2015. Dr. Morris was formerly Pharmaceutical Director, IMB, responsible for the assessment of quality data (CMC data) and before that Senior Pharmacist at the Irish National Drug Advisory Board. Prior to this, he was a Research Pharmacist at Sterling Winthrop R&D. Dr. Morris obtained a Ph.D. from the University of Manchester (UK). Dr. Morris was the EU member of the ICH Q6A Expert Working Group, and in 2003 led the Group for the revision of the ICH Guideline Q3B. He was a member of the CPMP/CVMP Quality Working Party until 2003, and in 2004 was elected to the position of Chairman of the European Pharmacopoeia Commission. Currently he remains a member of the European Pharmacopoeia Commission and is still active in ICH being Rapporteur (Chair) and EU topic leader for Q4B-pharmacopoeial harmonization. |
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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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jmorbit@cfpa.com
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