Life Sciences Webinar: From EVMPD to Regulatory Information Management: A Logical Transition

March 30, 2012
10:00 a.m. Eastern Time / 15:00 GMT

Implementation of the EVMPD mandate has been moving slowly, held back by corporate uncertainty as to the full requirements, hesitancy over how to proceed and a dearth of clear guidance from the regulators. By the end of 2011 - the halfway point between announcement of the EVMPD and the mandate's start date - the industry was still waiting for the European Medicines Agency to provide the testing environment, respond to questions and offer further guidance.

Now, with just four months to go, any company that hasn't got its data in order or at least a firm plan for collecting and transferring the required data will be struggling to meet the July 2 deadline and will need to make some rapid contingency plans. But even companies that are on the right track need to plan for the long term. EVMPD is just the start. In 2015 the standards will evolve even further, via the ISO format. Furthermore, other regulators have their own demands around regulatory data.

The need for a well-considered regulatory information management solution becomes all the more critical in today's more volatile regulatory climate. It won't be adequate to simply invest in a technology solution, because without a commitment to process change and central management of the information, there can be no real control and oversight of critical regulatory data.

In this second CSC EVMPD Webinar, our speakers take you farther down the path of EVMPD - and, ultimately, regulatory information management - enlightenment.

Presenters:
Andrew Marr, managing director of Marr Consultancy, has more than 25 years of experience in the pharmaceutical industry in the areas of regulatory affairs and operations and has been deeply involved in development of ISO standards for identification of medicinal products.

John Farrell, Principal Consultant with CSC's Life Sciences practice. With a twenty five year career history in the regulated medical sector John has extensive experience in the regulatory aspects of both medical devices and pharmaceuticals. John's particular focus is on technology enabled business process change and he has worked with a large number of clients, including national regulators, on delivering effective compliant processes which both maintain regulatory compliance and deliver the potential benefits of developments in technology. John is an acknowledged author on two of the GAMP Good Practice Guides. Currently John has particular responsibility within CSC for services in support of XEVMPD compliance.

Date:
The Webinar is scheduled for March 30, 2012, at 10 a.m. Eastern time. Register now