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banner[0]='Impact of FDA/European Agencies Changes on the Global Environment: Medical Devices
The global role of the US Food and Drug Administration (FDA) is evolving, and FDA and European agencies are collaborating more than in the past. In this session, you will hear from EC experts and FDA representatives from the Center for Devices and Radiological Health (CDRH) who have been closely involved in establishing the agencies\' global footprints. More info »
Update on the Assessment of Benefit/Risk: Views from FDA and European Medicines Agency
This session will explore how the leading regulatory agencies are using new methodological approaches to assess the benefit/risk profile of medicines and medical devices, how benefit and risk should be presented in the clinical overview section of a dossier and how the profile should be communicated to healthcare professionals and patients. More info »
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banner[1]='Impact of FDA/European Medicines Agency Changes on the Global Environment: Pharmaceuticals
Explore how the changing roles of the US Food and Drug Administration (FDA) and the European Medicines Agency are impacting the development of pharmaceuticals, the registration of existing products in markets outside the US and risk assessment. More info »
Emerging Regulations: Is Harmonization a Thing of the Past or Still a Hope for the Future?
Have harmonization efforts delivered anything practical or is it becoming more and more of a distant hope? In this session, you will be discuss whether or not the harmonization process has delivered any tangible benefits and where there may be tangible benefits still to be gained. More info »
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banner[2]='Transparency and Global Agencies
Transparency among global regulatory agencies provides a unique set of benefits and challenges. Through discussions with FDA, Health Canada, and European Medicines Agency, discover how agencies share information and make judgments that could impact you and your company. More info »
Social Media—Benefits and Challenges
The control of message content, delivery, and response are no longer unilateral, and the tools behind Social Media are expanding in uses within the life science industry not previously imaginable. This session will identify both the powerful benefits of social media afforded to life science manufacturers, such as patient adherence and outcomes-based feedback, as well as significant new risk factors that make approved, balanced communication compliance more challenging. More info »
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banner[3]='Developing and Mentoring Regulatory Staff for the Global Regulatory Environment
The competency, experience and performance of your regulatory staff are critical. This session will examine how regulatory leaders cultivate and mentor other regulatory professionals to build a complete awareness of international regulations and learn how to think and respond on a global level. More info »
Comparative Effectiveness and Healthcare Reimbursement
Learn about comparative effectiveness research and how it impacts US regulatory strategies with a thorough review of the methodologies that are used to gather comparative data. Engage in a dynamic follow-up discussion on how to incorporate these methodologies into product development. More info »
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