Future Perspectives in Pharmacovigilance

Venue: The Park Bangalore

Location: Bangalore, India

Event Date/Time: Mar 03, 2012 End Date/Time: Mar 04, 2012
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Ask the Experts - Join international pharmacovigilance experts for an open Q&A session to discuss your most difficult pharmacovigilance challenges.
DIA Special Interest Area Communities (SIACs)

• Safety Management during Early Drug Development program
• US and EU Safety Regulation Updates - New FDA Rule / DSURs
• Safety and Regulatory Writing
• Medical Devices Vigilance
• Panel Discussion on Schedule Y and Empowerment to ECs/IRBs
• India as Pharmacovigilance Outsourcing Destination
• Safety during Clinical Trials through Medical Monitoring
• Integrating Pharmacovigilance in Medical and Para Medical Curriculum
• Utility of Cloud computing in Pharmacovigilance Database Domain

All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.

Learning Objectives:
At the conclusion of this workshop, participants should be able to:
• Explain key aspects of current global safety reporting requirements for prescription and over-the-counter drugs
• Discuss new pragmatic approaches to pharmacovigilance as proposed by the CIOMS working group
• Describe the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan
• Identify best practices for quality assurance in post marketing pharmacovigilance and clinical safety

Target Audience:
Professionals with experience in clinical safety and who are involved in:
• Pharmacovigilance
• Clinical research
• Risk management
• Compliance
• Medical information
• Regulatory affairs
• Academia
• Pharmacology

Event Code: