The Guide to FDA Pharma GMP Regulations – 2011 is a compilation of pharmaceutical GMP regulations that puts all the authoritative information you need in one place.

This new report from FDAnews takes you step by step through how to prepare for and how to conduct yourself during — and after — the critical preapproval inspection.

This report is the clearest and most practical training available today for avoiding problems with off-label promotion.

Looking for international manufacturing partners and API suppliers? The Far East is no longer your only option. Companies in Central Europe (CE) and the Balkan states are actively seeking new markets and new partnerships with Western businesses. And these outsourcers have developed capabilities, credentials and business operations that are helping them outperform established competitors in the Far East and other regions of the world. What would a new CE/Balkan firm partnership mean for you? Which CMOs and suppliers would be your best match? Country by country, what trends are complicating outsourcing … and which are opening profitable new options? Here’s the best source for information on all the most promising opportunities.

This management report is designed to address your specific concerns about PREDICT and the new FDA import processes — and show you how to prepare to successfully get your imported products through customs as quickly as possible.

If a user discovers a deficiency in a device prior to use, does it have to be reported in the EU? How about the US? In the EU, do you need to report adverse events to the competent authority where the event occurred, where the device was made, or both? If an adverse event takes place involving a medical device made in the US, but the device is not available for sale in the US, must it be reported to the FDA?

The FDA originally videotaped these 10 training sessions — more than eight hours’ worth — to train its own staff in quality training. Now FDAnews has brought all 10 sessions together on one convenient, affordable DVD, designed to give you the kind of high-level employee education everyone wants … with the flexibility that makes in-house training most beneficial.

This management report from FDAnews provides drugmakers and suppliers with a thorough overview of the EU’s risk management approach.

Now you can tighten up your auditing process and keep the FDA out of your hair. This timely Special Report from FDAnews, Supplier Qualification: Developing Risk Assessments and Audit Programs That Work, will show you how.

From infectious diseases to cancer tests, the point of care (POC) diagnostics market was worth a hefty $13.7 billion in 2010. What will it be worth by 2016?  Which sectors will soar or stagnate? How will regulatory and clinical drivers affect growth?

FDA Pharma Manufacturing Essentials brings together tested and practical advice that tackles the most pressing issues a pharma executive faces ... all in one, high-level and comprehensive resource.

Whether you’re a newcomer to Asian markets, or looking to keep your contacts fresh, Sourcing Medical Devices in Asia 2011 is an invaluable reference. You get advice on how to avoid and troubleshoot the problems and pitfalls that may arise in the course of the sourcing process, as well as information about insurance, payment arrangements, freight forwarding and customs. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided hundreds of companies with the regulatory information and business strategy to succeed in the Asian markets.

China Pharmaceutical Market Report 2011 is the research report that contains key information on important aspects of the Chinese pharmaceutical market. This book provides an overview of current conditions in the Chinese healthcare market. It is an invaluable resource, whether you are planning to expand your reach into China for the first time or simply need a veteran’s perspective on the country’s marketplace to manage your ongoing efforts.

Contract Research Organizations in Asia 2011 is the research report and directory that will help you find partners in 11 countries to assist you in carrying out safe, accurate and compliant clinical trials. In addition, this report provides an overview of the growth of trials in this part of the world along with Asian healthcare and industry statistics. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided hundreds of companies with regulatory information and business strategies to develop Asian markets.

China Pharmaceutical Regulatory Report 2011, the research report that gives you a thorough understanding of the Chinese regulatory structure governing the drug industry. You’ll get a complete discussion of the laws and regulations that govern the testing, product registration, manufacturing, importing, marketing and sales of pharmaceuticals. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided hundreds of companies with regulatory information and business strategies to develop Asian markets.