SMi are proud to present their 3rd annual conference on Pharmacovigilance due to take place in Central London over the 1st & 2nd July 2013. A year after the introduction of the new Pharmacovigilance legislation was enforced SMi take a look back at the successes and failures in the first year of its implementation. With concerns occurring across the board in relation to PV auditing, companies face the challenge of understanding the key considerations when presenting to auditors. Unravel the challenges in compiling and presenting the new PSUR to external regulatory bodies and determine what these regulatory bodies have learnt in the wake of its recent introduction.
The introduction of the new legislation has led to a significant change in how companies present there data and safety studies to external regulatory bodies. This has ultimately led to a lack of understanding in what is expected upon data presentation. Attend this fantastic forum to discuss the format and content of Periodic Safety Update Reports and how data integration and additional modules are incorporated into this documentation to provide a far more comprehensive overview of a drugs safety and efficacy. Join SMi as they look tackle these issues and many more at a summit that promises to be a must see event.
Benefits of Attending:
• Understand the main points to consider when presenting a PSUR to external regulatory bodies.
• Tackle the issues and importance of adverse event reporting.
• Discuss the importance of pharmacoepidemiology and what can be learnt from global trends.
• Assess the benefits and challenges involved with outsourcing pharmacovigilance processes.
• Listen to case studies from companies that have undergone recent pharmacovigilance auditing and what was expected.