FDA Pharmaceutical and Medical Device Books
Published: January 2011 | Pages: 74 | Price: $1,500
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: April 2012 | Pages: 155 | Price: $750
In this clear yet comprehensive new resource developed by Access China Management Consulting Ltd., FDAnews provides an English-language guide that makes it easier to navigate the Chinese medical device registration system.
Published: April 2012 | Pages: 231 | Price: $1,495
With a new resource developed by Access China Management Consulting Ltd., FDAnews offers non-Chinese companies the know-how to move into China’s lucrative pharmaceuticals market without giving up their intellectual property rights.
Published: November 2009 | Pages: 27 | Price: $377 | ISBN: 978-1-60004-079-5
Cleaning Validation: Strategies for Compliance goes beyond the regulations and digs into the real-life world of cleaning validation. Tips to create an effective master plan ... appropriate SOPs ... auditing for compliance ... practical solutions to troublesome cleaning validation challenges ... this timely volume help keep the FDA at bay, boost production efficiency, and fatten your bottom line.
Published: April 2011 | Pages: 600 | Price: $350 | ISBN: 1355-4808
From GCP compliance and guarding against fraud to recruiting subjects and ensuring adequate informed consent, the challenges posed by running clinical trials can be overwhelming. And conducting trials across different countries only multiplies those challenges. The varying approaches to product registration, monitoring and approvals in different countries means country-by-country compliance headaches. Now, practical guidance on all these topics and more is available in one, expert-written volume.
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.
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: March 2013 | Price: $597
In more than 10 years running the Clinical Trials Centre at the University of Hong Kong, Johan Karlberg, MD, PhD, BSc, helped manage more than 640 sponsored trials, and he witnessed all the hurdles that can trip up trial sites. More GCP training, he concluded, is not the answer to the problems the sites faced. What they needed was a simple mechanism to bring themselves into compliance with GCP regulations and best practices. And the Clinical Trials Magnifier Clinical Trial Site SOPs were born.
Published: June 2012 | Pages: 283 | Price: $377 | ISBN: 978-1-60428-059-3
Something’s gone wrong in one of your clinical trials. But ... is it an adverse event? What should you do next? Get the facts.
Published: April 2012 | Pages: 193 | Price: $3,500
Many CROs and sponsors are speeding recruitment and cutting the costs of clinical trials by conducting them in Central Europe. But not every Central European country is a good choice for every product. You need to understand the specialties and healthcare strengths of each country, the major CROs in the region, what drugs are already being tested, and which countries generate registration delays, as well as the impact of revised clinical trials regulations in Europe. You can’t afford to commit to a location only to discover that restrictive legal requirements and registration delays eat up your development time and budget. Here are the facts, insights and forecasts it takes to get the decision right.
Published: June 2008 | Pages: 30 | Price: $327 | ISBN: 978-1-60428-013-5
Clinical Trials Indemnification Clauses: Pitfalls and Problems to Avoid is the management report that examines the most problematic areas in negotiating indemnification clauses. This report highlights the key topics you need to address and provides insight into the types of agreements that are generally accepted standards in the industry.
Published: April 2005 | Pages: 259 | Price: $245 | ISBN: 1-932074-31-7
Here's an essential guide for manufacturers seeking FDA approval of groundbreaking new medical products and therapies that combine drug, device or biologic therapies.
Now available as a book/CD-ROM set or individually.
Published: November 2011 | Pages: 85 | Price: $377 | ISBN: 978-1-60004-263-8
Here in one authoritative source is what clinical trial sponsors must know before venturing into China. This management report provides an overview of China’s current regulatory landscape and points out key differences from US and European requirements.
Published: September 2009 | Pages: 43 | Price: $377 | ISBN: 978-1-60004-083-2
This all-new guide from FDAnews walks you through the steps of managing supplier audits, from initial contract negotiations ... to risk assessment ... to actual conduct of audits ... to documenting and preparing for FDA inspection.
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.