RAPS 2012 - RAPS Approved Seminar on GMP and Regulatory Expectations for Early IND Products At Mumbai

Overview: This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.
Why should you attend: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.
Seminar Content: India Seminar 2012 at Mumbai:
Day 1 - 18th June 2012
? Lecture 1: Very Early Stages
? Lecture 2: What the ICH Q8 Annex covers
? Lecture 3: GLP requirements
? Lecture 4: GLP-based Animal Studies
Day 2 - 19th June 2012
? Lecture 5: Early Pre-IND Studies
? Lecture 6: The Preclinical/Clinical Interface
? Lecture 7: The Animal Rule and Orphan Drugs
? Lecture 8: Pediatric considerations
Day 3 - 20th June 2012
? Lecture 9: GMPs for Phase 1 Products. Part 1
? Lecture 10: GMPs for Phase 1 Products. Part 2
? Lecture 11: Phase 2 Products
Who Will Benefit
? Presidents
? Vice Presidents of Technical Departments
? Managers
? Directors
? Regulatory Associates and Analysts
? Quality
? Regulatory
? Research
? Development Group Heads
About Speaker: Dr Steven S. Kuwahara currently heads GXP BioTechnology . He is an experienced analytical biochemist who has applied his knowledge to the quality control area of pharmaceuticals. His work has dealt with all aspects of GMP and GLP in relation to drugs and biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and nutritional supplements.
Dr. Kuwahara has written many papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, Journal of Validation Technology, and Journal of GXP Compliance. For the last of these, he also writes a column called “The GLP Forum.”
He has held certifications such as CQA, CQT, and CQE from the American Society of Quality, and was certified RAC by the Regulatory Affairs Professionals Society.
DATE AND VENUE:
18th, 19th and 20th June, 2012 at Mumbai
Conference Timings: 9:00 am - 6:00 pm
Intercontinental The LaLit,
Sahar Airport Road, Andheri East
Mumbai - 400059 INDIA
Price ? Rs18000
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