Sponsor or Organizer: Global Compliance Panel

Description: 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.

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

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

Dates: 18th, 19th and 20th June, 2012 at Mumbai

Location: Mumbai, Maharastra, India