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.

Published by Pacific Bridge Medical and completely updated for 2011, India Pharmaceutical Regulatory Report 2011 is the timely research report that provides a thorough understanding of India’s regulatory structure governing the pharmaceutical industry. This report comprehensively covers all aspects of pharmaceutical regulations in India. In addition, it includes an overview of the Indian pharmaceutical market and foreign involvement in the market up to 2011. How suited the country is to different kinds of market entry — manufacturing, sales and research — is discussed in relation to the regulatory and market environments.

To avoid FDA warning letters, it’s no longer enough to have purchasing agreements with shippers that make passing reference to quality contracts. You need ironclad supply chain quality agreements. But what does a good quality agreement look like? How do you negotiate it with warehouses, wholesalers and shippers? And, then, how do you document compliance?

As a clinical trial sponsor negotiating a trial budget, you need to clearly understand what costs are billable to third-party payers, including Medicare, before you sign contracts. Failure to properly address this can result in budget problems, inadequate liability coverage, or even fines and other penalties. Here’s how to avoid Medicare billing problems in your clinical trials: Billing Medicare for Clinical Trials Costs: Avoiding Noncompliance and Budgeting Accurately

Medical Device Complaint Management: A Guide for Compliance provides a complete explanation to help you comply with FDA requirements.

Step-by-step, this report helps you master the many aspects of change control and the many regulations that must be factored into emergency decision-making and routine company procedures.

To date, the FDA has approved more than 100 Risk Evaluation and Mitigation Strategies (REMS) plans ranging from simple medication guides to complex, multi-part programs. Now drugmakers can take advantage of the lessons learned from these early, successful REMS — and avoid substantial delays and serious problems that might arise while satisfying FDA requirements about product safety.

Minimize your risk of FDA enforcement action with the agency’s own drug safety regulatory reference guide.

Despite years of harmonization talks, the EU and US still follow very different marketing approval processes for medical devices. And when the EU’s MDD went into effect in 2010, those differences became more pronounced. Failing to know the differences could critically handicap your time to market and ability to operate efficiently. Failing to comply with those differences could shut you out of EU markets completely.

Do you prepare your medical device facility for an FDA inspection the same way you did last year — or even six months ago? If you do, you could be in big trouble. The rules of the game have changed and the FDA is cracking down harder than ever before … and it’s only going to get worse.

Drug manufacturers: Be careful what you wish for. For years, drugmakers have urged the FDA to revisit 21 CFR Part 11, which governs electronic records. Now the FDA has done so — and the industry faces new compliance burdens.

If you're going to conduct clinical trials or sell drugs in the EU, the way you handle safety reporting will be essential to your success. But navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life, and it varies subtly from one member state to the next. The only sane way to approach these requirements is to incorporate them into your company's risk-management processes and procedures.

Clinical trials operators — the FDA is drawing a bead on you. Since 2008, the agency has issued 52 warning letters to investigators, CROs, sponsors and IRBs — an astonishing 30% increase over previous levels.