USFDA & EU Essentials of Drug Safety and Pharmacovigilance - India Seminar 2012 at Mumbai

Online, February 9, 2012 (Newswire.com) - The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Product safety makes headlines every day - and the impact on a company's image, consumer confidence, and Wall Street's opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.
Agenda:
• Overview of Pharmacovigilance
• Assessing Adverse Event Cases
• Reporting Adverse Events
• Global Regulatory Requirements
• Inspections and Audits
• Pharmacovigilance Best Practices
• Preparing for an Inspection
• Case Studies with Real-Life Inspection Findings
• Background to Signal Detection
• Signaling Exercises
• Data Mining Exercises
• Pharmacovigilance and Risk Management Process
Who will benefit:
• Drug safety and Pharmacovigilance
• Regulatory affairs
• Clinical development
• Executives (including C-Level) with any Legal responsibility for drug safety
• Clinical safety staff
• Pharmacovigilance specialists
• Regulatory affairs professionals
• Quality management specialists
• Management involved in clinical oversight
• Pharmacovigilance
• Pharmacoepidemiology
• Regulatory affairs

Steve Jolley, Principal, SJ Pharma Consulting
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 Years' experience in drug safety & Pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide.

DATE AND VENUE:
March 5th, 6th and 7th, 2012
at Mumbai, INDIA
Conference Timings: 9:00 am - 6:00 pm

Contact Information:
Event Coordinator
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