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*Featured Webcasts:*
ON DEMAND Moving Beyond Document Management to Enterprise Content Compliance This webinar will examine the growing trend in the life sciences industry away from traditional document management systems to emerging Enterprise Content Compliance (ECC) solutions. You'll learn how ECC solutions are changing and accelerating traditional regulatory document preparation by allowing companies to compress the time spent authoring and reviewing content for protocols, submissions, labeling, clinical trial disclosure, and other mandates.
» Register Free!	Sponsored by: Virtify

ON DEMAND 21 CFR Part 11, Computer Systems Validation and the Requirements of the FDA Computer Systems Validation is an activity that presents complex challenges to the life sciences community. Conflicting information from the FDA and the evolution of multiple industry standards for technical data set validation including Good Automated Manufacturing Practice (GAMP) 4 and 5 have caused confusion and uncertainty within the industry. Join us to hear from industry and compliance experts that know the facts around computer systems validation. Hear about common challenges and how to overcome them. Discuss the definition and scope of validation (including SaaS solutions), identify what the FDA says about validation, and learn best practices that you can implement in your organization to help ensure your systems are compliant with FDA's expectations and company business objectives.
» Register Free!	Sponsored by: Cegedim Dendrite

Featured Podcasts:

Trends in Patient Access: How Health Reform, Cost of Care and Stakeholder Response Will Shape Pharmaceutical Product Utilization
Questions abound over the impact that health reform and related measures will have on patients' ability to receive the medications they want and need. Join us as we discuss what pharmaceutical manufacturers, payers, providers and patients are doing in response to this dynamic healthcare environment.

» Listen

Sponsored by: AmerisourceBergen Specialty Group

Whitepapers:

Safety Document Exchange in the Global Clinical Research Environment
Serious Adverse Event (SAE) reporting can have severe repercussions both for patient safety and company reputation. By choosing a portal solution from a SaaS provider with state-of-the-art online security features, a sponsor or CRO can maintain real-time distribution and access reports for all documents shared, helping maintain compliance and data privacy.

» View Whitepaper

Sponsored by: Intralinks

The U.S. Health Care Reform Opportunity: Implications and Recommendations for the Life Sciences Industry
Health care reform is forcing the industry to expand its view of which government stakeholders and influencers are key. A systematic approach in evaluating these stakeholders and government-sponsored initiatives, such as Comparative Effectiveness Research, Health IT, Electronic Health Records, is crucial in understanding their potential impact on a company’s pipeline and in-line products and essential in determining how to engage government stakeholders in a productive and mutually beneficial manner.

This report provides a summary of the health care reform issues that have emerged as important to related industries. For life sciences companies in particular, the implications of those issues are examined and a new approach in addressing the government as a key stakeholder is explored.

» View Whitepaper