Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market is the research report that tells you how to obtain orphan drug status for products in Asian countries and the benefits that go along with it. This invaluable guide to Asia reviews orphan drug regulations across the continent and discusses crucial business issues unique to that part of the world. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided more than 200 companies with regulatory information and business strategies to develop Asian markets.

Quality of Life Claims, Marketing and the FDA: Creating a Competitive Advantage in a Crowded Market, the management report from Value of Insight (VOI) Consulting, Inc. and FDAnews maps out what’s required to pass muster with CDER and DDMAC — and how to avoid extra trial costs by building in QoL data-gathering right from the start. By combining exclusive surveys with real-world guidance, Quality of Life Claims, Marketing and the FDA helps you zero in on your own best strategy. Plus, you’ll learn how companies have used QoL claims and marketing to turn pipelines from lackluster to blockbuster.

Recruitment and Retention in Clinical Trials: What Works, What Doesn’t and Why shows you how to trade outdated strategies for clinical trial retention and recruitment solutions that get your therapies to market faster — and for less.  This one source connects you with today’s most innovative, effective tools and tactics. From turning physicians into powerful allies, to simple education strategies that can boost recruitment 50 percent, you’ll discover how to win participation from a wider pool of subjects and keep them on board.

Effective Techniques for Monitoring Medical Devices in Clinical Trials, the management report brought to you by RxTrials Institute. Discover the details that will help you quickly distinguish between unanticipated adverse device effects (UADE), adverse events and procedural complications from operator error and reporting each event with confidence, understand the relationship between good clinical practice (GCP) and the monitoring of your medical device trials, and accurately apply risk management principles to GCPs.

Clinical Trial Site Selection: Strategies to Gain a Competitive Advantage ensures the research sites you select will meet your needs. You’ll discover proactive pointers to help you find out — fast — if a research site can recruit the subjects you need, think outside the “draft protocol” box, and make sure that your sites share risk with you.

Brought to you by FDAnews, Prepare for Increased Enforcement of Off-Label Promotion Regulations is a management report that delivers solid strategies to keep you in compliance with off-label promotion laws. Stay off the FDA’s “hit list” for good, and avoid millions of dollars in criminal and civil fines.

This management report from FDAnews, Secrets of Successful Advisory Committee Meetings, brings you the tips and tactics you need to get positive advisory committee recommendations. As the FDA begins to weed out advisory members with ties to drug and device companies, you can still rely on the step-by-step strategies in Secrets of Successful Advisory Committee Meetings to achieve success with the new, more critical round of FDA panelists.

From FDAnews, Generic Challenges to Patent Rights: The Legal Battle maps out trial, pretrial and business strategies for “generic-proofing” patents. From active-ingredient formulation to polymorph, method of treatment and process patents, you’ll learn specific approaches brands can use to deflect intellectual property challenges from generic companies.

Discover step-by-step how you can profit from shorter cycle times, greater product availability, higher yields and more — when you put PAT tools to work at key phases of your manufacturing process. You'll even jump the learning curve with eight dos and don'ts of a successful PAT program.

Now, your risk assessment team can learn today’s best strategies for designing and coordinating safety studies that deliver reliable data efficiently. In this book, two world-renowned authorities connect you with practical tips from real-world experts and former FDA officials. Reaching beyond what’s available in regulations or guidelines, here’s the know-how to prevent delays and “do-overs” and give your program the absolute best chance for success. Available in print or CD-ROM format.

Don't miss out! Successfully sidestep the delayed approvals, lost product batches and plummeting profits that can result from change control failures with this comprehensive report. Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers.

Glean real-world insight with examples of working change control systems, specifically targeted to the unique needs of drug and biologic manufacturers, with this new management report. Don't delay, order this distinctive management report filled with common sense procedures on change control that you can use today.

Which media outlets are the most — and least — effective for encouraging the elderly, children and African American participants to enroll in your clinical trial? And what strategies are already working to locate these special populations? Find out today. Plus, use a detailed and successful case study to help you quickly apply "special population" recruiting techniques to your next clinical trial.

Find out what the FDA expects from your next clinical trial with this comprehensive management report from FDAnews — How to Create and Structure a Data Monitoring Committee: Strategies for Future Trial Design.

This management report from FDAnews, shows you how to develop a plan to protect yourself from liability and educate your investigators and staff about the importance of upholding confidentiality agreements. Confidentiality in Clinical Trials: Understand Your Liability is a first-line resource to help you learn what the issues are and what you need to do to keep your data secure and your organization safe from unwanted intrusion.