Overview: Each lecture will be 90 min in length. There will be morning and afternoon breaks of 30 min each which will be reduced to 15 min, if needed to accommodate long lectures. Lunch will be at least 1 hr in length.
The instructor will be available for questions and discussions during all breaks and lunches and will also be available for a minimum of 30 min at the end of each day.
The first day’s presentations will be for those who are new to the U.S. regulations. The second day’s presentations will be aimed at people in Regulatory Affairs or Clinical Studies, and the third day’s presentations will be directed at those who have some prior knowledge of the regulations.
Seminar Content: India Seminar 2012 at Mumbai
Day 1 - 18th June 2012
· Lecture 1: Introduction to U.S. Drug Regulation
· Lecture 2: Laws and Regulations in the U.S
· Lecture 3: The U.S. Drug GMP- Part 1
· Lecture 4: The U.S. Drug GMP – Part 2
Day 2 - 19th June 2012
· Lecture 5: Violations and Responses
· Lecture 6: Filings and Submissions - DMF and Clinical Trials
· Lecture 7: Filings and Submissions – NDA and BLA
· Lecture 8: Inspections and Audits
Day 3 - 20th June 2012
· Lecture 9: An Overview of ICH Q8,Q9, and Q10
· Lecture 10: Risk Analysis and Corrective and Preventive Actions (CAPA)
· Lecture 11: Biosimilars in the U.S., An Overview
· Lecture 12: Process Validation
Who Will Benefit:
• Vice Presidents of Technical Departments
• Regulatory Associates and Analysts
• Development Group Heads