16 July 2008
12:00–1:30 pm ET
Alexander P. Ruggieri, MD, MHS, President and Chief Medical Officer, Medcognition
Description: Safety monitoring is a fundamental regulatory requirement for all marketed medical products. While the general expectation for safety monitoring by legal authorities has always existed, specific requirements and expectations continue to evolve with advances in information science and technology amidst an environment of increased scrutiny.
By participating in this Webcast you will understand the rationale for pharmacovigilance requirements set forth by EMEA and FDA so that you will be able to prepare and plan for necessary infrastructure and process changes to help build a durable strategy for pharmacovigilance programs within your organization.
Learning Objectives: Upon the Webcast's conclusion, you should be able to:
- Recognize the rationale for the elements of pharmacovigilance expected both for US and European regulatory perspectives
- Determine the infrastructure, business processes and work products required to meet current pharmacovigilance requirements
- Apply pharmacovigilance expectations and requirements to evaluate your organization’s readiness, plan for necessary infrastructure and process changes and build a durable strategy for pharmacovigilance programs within your organization
Who should attend :
- Regulatory professionals seeking an understanding of pharmacovigilance
- Individuals embarking on or considering a career as safety and risk management professionals
- Compliance professionals
- Anyone seeking to understand the basis for existing and changing pharmacovigilance requirements and expectations from global regulatory bodies
Professional Levels: I, II
About the speaker:
Alexander P. Ruggieri, MD, MHS, is President and Chief Medical Officer for Medcognition, a private consulting organization that provides information management solutions and medical knowledge applications in the domain of safety and risk management for drug and biopharmaceutical developers and marketers. In addition to his medical and clinical background, Dr. Ruggieri has qualifications in information science, data analytics, pharmacovigilance and pharmacoepidemiology. He has worked as Medical Director for Global Safety and Director for Information Management and Strategy in Global Regulatory Affairs and Safety at Amgen, Chief Medical Officer, and Senior Director for Safety Solutions at Cerner Galt, and currently works as a consultant.
Cost: RAPS Members: $325 USD; Nonmembers: $400 USD
Cost is per site—unlimited participants!
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What is a Webcast?A Webcast is a live, interactive event—very much like a private talk-radio program, with the added feature of viewing visuals on the web. Webcasts are a great opportunity to train your entire staff for just one low cost!
To listen to the audio portion of the seminar, you need only a touch-tone telephone (a speaker phone is required if more than one person per site will listen). To access the Internet portion of the seminar, you need a separate Internet connection with a current version of Internet Explorer or Netscape, in addition to the telephone line.
Cancellation and Refund Policy: : Written cancellations received by 12:00 pm ET on Tuesday, 15 July 2008 will be refunded the registration fee minus a $100 administrative fee. Refunds will not be granted for failure to attend, changes to the agenda or speakers or for sites that do not meet the minimum system requirements needed to attend a RAPS Webcast. Cancellations must be received in writing via email at raps@raps.org or via fax. RAPS does not accept phone cancellations.
Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.
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