FDA Pharmaceutical and Medical Device Books
Published: September 2007 | Pages: 143 | Price: $337 | ISBN: 978-1-60428-000-5
Recruitment and Retention in Clinical Trials: What Works, What Doesn’t and Why shows you how to trade outdated strategies for clinical trial retention and recruitment solutions that get your therapies to market faster — and for less.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.
Published: September 2007 | Pages: 114 | Price: $337 | ISBN: 978-1-60428-002-9
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.
Published: September 2007 | Pages: 146 | Price: $337 | ISBN: 978-1-60428-006-7
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.
Published: September 2007 | Pages: 328 | Price: $337 | ISBN: 978-1-60004-148-8
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.
Published: September 2007 | Pages: 168 | Price: $337 | ISBN: 978-1-60004-154-9
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.
Published: June 2007 | Pages: 1092 | Price: $337 | ISBN: 978-1-60004-146-4
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.
Published: May 2007 | Pages: 109 | Price: $335 | ISBN: 1-60004-058-6
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.
Published: May 2007 | Pages: 620 | Price: $495 | ISBN: 1-60004-054-3
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.
Published: March 2007 | Pages: 112 | Price: $395 | ISBN: 1-60004-138-8
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.
Published: February 2007 | Pages: 143 | Price: $395 | ISBN: 1-60004-136-1
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.
Published: February 2007 | Pages: 125 | Price: $335 | ISBN: 1-60004-134-5
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.
Published: December 2006 | Pages: 151 | Price: $377 | ISBN: 1-60004-092-6
This indispensable management report maps out a comprehensive strategy for recall planning. From creating a recall committee to handling communication and policy changes during a recall, you'll be at work with today's best practices for containing damage and keeping your edge.
Published: November 2006 | Pages: 215 | Price: $337 | ISBN: 1-60004-084-5
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.
Published: October 2006 | Pages: 106 | Price: $297 | ISBN: 1-60004-075-6
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.
Published: October 2006 | Pages: 109 | Price: $297 | ISBN: 1-60004-079-9
Don't let complex foreign laws, practices and customs derail your clinical trial in an underdeveloped country. Now you can sidestep some of the most significant risks of conducting trials in underdeveloped countries, with this management report from FDAnews.