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.

From FDAnews (published by Euromed Communications), this loose-leaf manual shows you how to satisfy all European regulations affecting your medical devices. You’ll find clear, practical and up-to-date guidance for every class of medical device and at every stage in the product life cycle, from selecting your conformity assessment route to registering with a competent authority and complying with global harmonization.

Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings, a management report from FDAnews, maps out every aspect of an import hold, including how to fix problems before they land your shipment in trouble with FDA and customs officials, the best way to train your team to use the right (and avoid the wrong) approaches with FDA personnel and when to activate a rapid-response strategy that gets your imports off hold and into use fast.

Order your Nine-Volume Title 21 CFR Set today! The federal government has just compiled the new Nine-Volume Title 21 CFR Set for 2013 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2013.

At its heart, our industry is about saving and improving lives. That’s what draws people into this business in the first place. But sometimes people need reminding about that. That’s what this classic training DVDs has been doing for years, with powerful stories that remind people exactly how GMP compliance affects real life.

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.

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.

Filled with timely, accurate and comprehensive guidance drawn from the world’s three major markets — US, Japan and the EU — this Manual covers new and revised regulations affecting clinical research — as well as the most recent thinking on ethical issues such as human subject protection and informed consent.

Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected? Do your plans for dealing with drug shortages satisfy the new PDUFA requirements? How about your supplier quality agreements? Your facility registration? Your fast-track NDA? Your . . .

With Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS, you'll have the tools to create and maintain a CCDS that will withstand regulatory scrutiny, and you’ll avoid the unnecessary extra work that comes from assuming what’s the best way to write them.

Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes. Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.

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.

Attention drug and device manufacturers — the new health reform law is about to turn your marketing world upside down. Under new rules, companies like yours must begin collecting data about payments to physicians. And that’s just the tip of the iceberg …

Keep disasters from disrupting your trials, destroying costly data or endangering patient safety! Drawn from real-world experience, this management report was developed to help you create and implement a disaster management plan specifically for clinical research activities.

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.