EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,...

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affair...

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Why should you Attend: In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial. Areas Covered...

FDA regulations cover both the use of workbooks and the creation of electronic records device manufacturers must understand these regulations and their application. The presentation begins with Excel methods to help ensure the spreadsheet produces the results you want. Why should you Attend: Excel workbooks must produce correct results, so the first concept helps ensure correctness. Excel workbooks may also cause regulatory problems, because t...

According to leading research firm Deltek, Federal health IT will continue to grow overall shrinking budgets. Legacy systems are ripe for transformation as healthcare delivery becomes more preventative and patient-centric through the use of business processes that are more efficient and enabled by information technology. This video webinar will look at a broad range of technological advances from electronic health records and payment systems t...

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to...

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. Why should you Attend: This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laborator...

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lesse...

We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization. Why should you Attend: Because as much as we try, most regulated industries don't have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competenc...

Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program. Areas Covered In the Session: Discuss what FDA is...