ADVAMED Association News

MDRs, eMDRs and Global Adverse Event Reporting

AdvaMed SmartBrief | Nov 06, 2009

This two-day program, offered each fall, covers current practical and policy issues in U.S. and international adverse event reporting. The most recent program helped launch FDA's new electronic reporting procedures, but the content changes annually according to regulatory developments and industry needs. More information. Medical Technology Learning Institute -- Education Beyond a Degree

Sign up now for $250 discount

AdvaMed SmartBrief | Nov 06, 2009

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. Courses include MDRs; Clinical Trials; and Combination Products. Full agendas and logistical information can be obtained on our Web site. In order to receive your discount, please contact Katia Kunze at (202) 434-7237. Some restrictions apply.

Combination Products

AdvaMed SmartBrief | Nov 05, 2009

Key present and former FDA staff and industry experts discuss important regulatory and practical issues related to combination products, including the new proposed rules on GMPs and postmarket safety reporting for combination products. More information. Medical Technology Learning Institute -- Education Beyond a Degree

Advertising and Promotion of Medical Devices

AdvaMed SmartBrief | Nov 03, 2009

What are the regulatory and legal guidelines for appropriate advertising and promotion of medical technologies? How and when are companies permitted to disseminate off-label information or to respond to physician requests? Legal experts, company compliance officers and representatives from the FDA offer guidance in these and other areas. More information. Medical Technology Learning Institute -- Education Beyond a Degree

Risk Management 201

AdvaMed SmartBrief | Nov 02, 2009

This new workshop is designed for people familiar with risk assessment and risk management principles, who seek practical guidance on implementation in medical technology firms. It will enhance understanding of regulatory expectations and of workable methods to meet them. Lectures, breakout exercises of simulated industrial challenges, panel discussions, and networking opportunities will help participants make product decisions with risk management data and establish related policies and procedures. More information. Medical Technology Learning Institute -- Education Beyond a Degree

PMA Workshop

AdvaMed SmartBrief | Oct 26, 2009

Completing the MTLI set of interactive submissions workshops, Oct. 29 and 30 in Alexandria, Va., senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with FDA and the mechanics of submission development. More information. Medical Technology Learning Institute -- Education Beyond a Degree

IDE Workshop

AdvaMed SmartBrief | Oct 23, 2009

MTLI offers this one-day interactive workshop Oct. 28 in Bethesda, Md., to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE applications, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. More information. Medical Technology Learning Institute -- Education Beyond a Degree

510(k) Submissions

AdvaMed SmartBrief | Oct 22, 2009

This interactive workshop, Oct. 26 and 27 in Bethesda, Md., is taught by industry experts and key personnel from the CDRH 510(k) staff and leads participants step by step through the regulatory guidelines, practical steps and strategic considerations for determining a product's regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with FDA during the review process and dealing with post-clearance issues. More information. Medical Technology Learning Institute -- Education Beyond a Degree

Complaints, MDRs, Reports of Removals & Corrections, and Recalls

AdvaMed SmartBrief | Oct 21, 2009

How do you implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDRs, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Through didactic sessions, interactive exercises and discussions of pre-submitted questions, expert industry faculty and FDA speakers explore these issues in practical terms. More information. Medical Technology Learning Institute -- Education Beyond a Degree

Upcoming AdvaMed webinar session

AdvaMed SmartBrief | Oct 12, 2009

Don't forget to register for one of AdvaMed's upcoming webinar How to change the medical device Failure Cycle to get a Competitive Edge on Oct. 22. Webinar will be held from 1 p.m. to 2:15 p.m. EDT.

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