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Issue No. 4 |
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April 2009 |
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Industry News:
Postmarketing Study Commitment Trends for New Drugs: An Analysis of NMEs Approved in 2008
Given that the FDA Amendments Act of 2007 (FDAAA) took effect in late March 2008, the 2008 class of approved NMEs offered an early glimpse into how anxiously the FDA would wield its newly found powers regarding postmarketing requirements and risk evaluation and mitigation strategies (REMS).
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Events
We invite you to visit PAREXEL at these upcoming industry events. Events are a great way to get to know our experts, discuss your outsourcing challenges, and learn how PAREXEL’s global reach, technology and expertise can help your organization.
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| Cover Story:
Global Risk Management: Meeting the Challenge |
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Risk management for prescription pharmaceuticals is both a high priority and a significant challenge for the biopharmaceutical industry today. Numerous incidents involving the safety and risks of marketed pharmaceutical products in recent years have brought the issue to the forefront of public attention and regulatory scrutiny in the United States, Europe, and elsewhere around the world. Read more... |
| Expert Profile: |
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Anders Neil, Ph.D., Principal Consultant, European Early Stage Product Development, PAREXEL Consulting
Dr. Neil brought more than 30 years of experience in the pharmaceutical field when he joined PAREXEL in 2008, including positions with European regulatory authorities, academic research in pharmacology, and drug development activities for the pharmaceutical industry. Read more... |
Best Practices: Accelerating Global Product Introductions Through
Multi-country Regulatory Filings |
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The current global economic climate is generating tremendous pressure on bio/pharmaceutical companies to maximize the value of their assets. Sponsors with novel therapies need to speed up time-to-market and introduce their products in multiple countries as quickly as possible. Companies with established products want to increase their sales by expanding into additional markets to offset impending patent expirations. Read more... |
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