Webinar for Life Sciences Professionals: An Overview of US and EU Regulatory Processes

Dora Wirth (Languages) is proud to sponsor a 4-day webinar for life sciences professionals conducted by The University of Wisconsin and TOPRA (The Organization for Professionals in Regulatory Affairs).

This four-part webinar series introduces the framework and structure of regulatory and pharmacovigilance procedures in two key regions of the world. It is aimed at Life Sciences professionals who work within the drug development lifecycle, and want to learn more about global regulatory and pharmacovigilance processes.

There is still one Webinar left to attend!

Thursday, November 7 - The US Pharmacovigilance Requirements

What time?
10:00 am (EST). The webinar will last 60 minutes followed by an open Q&A session.

Part 4: The US Pharmacovigilance Requirements (Nov 7th, 2013)
Pharmacovigilance is a science concerning itself with collection and analysis of healthcare provider and patient data, in order to understand and prevent adverse effects from drugs and other biological products. Pharmacovigilance begins with the clinical testing of a product and continues throughout its life cycle. In contrast to the EU what does the US require? This webinar will focus on the current US requirements in contrast to those of the EU.

Who is presenting?
Knowledgeable Regulatory Affairs and Pharmacovigilance leaders will introduce the Regulatory approval processes for the US and [Patricia Duchene] the EU and the Phramacovigilance Requirements while also sharing their experience-based, practical insights and best practices with attendees.
• Nancy Smerkanich PhD. Regulatory Affairs Consulting,
• Patricia Anderson, Vice President, Regulatory Services, Life Sciences, OptumInsight
• Miranda Dollen QPPV, Director Pharmacovigilance, OptumInsight
• Elizabeth Ursell PhD., QPPV, Associate Director Pharmacovigilance, OptumInsight

For registration fees and to register for the series of Webinars, please visit: //ce.pharmacy.wisc.edu/mod/coursepage/view.php?id=3624