ADVAMED Association News

Defining Value Webinar: Implications of New Value Frameworks for Devices

AdvaMed SmartBrief | Feb 05, 2016

March 4 | Webinar
During this one-hour webinar, you will hear an update on comparative effectiveness research in the US. Value and implications for devices will be discussed. Agenda topics include changing market access, the role of new insurance benefit designs, the role of patient-centered care and more. You'll benefit from this webinar if you are involved with market access, HEOR or development and commercialization. Learn more.

2nd Annual AdvaMed Payment Policy Conference

AdvaMed SmartBrief | Feb 05, 2016

April 6-7 | Arlington, Va.
The current reimbursement and coverage landscapes for medical devices and the potential impact of changes in the environment on payers, health care providers and hospital systems will be discussed during this two-day conference. Speakers will include the Centers for Medicare and Medicaid Services, providers, private insurance plans, device manufacturers, hospital systems and more. Learn more.

FDA Submissions Strategy

AdvaMed SmartBrief | Feb 04, 2016

March 9-10 | Sunnyvale, Calif.
Effective navigation of the FDA application process requires an approach that is both thoughtful and strategic. This workshop is designed to prepare you for the development and execution of effective submission strategies for your Investigation Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs) and Premarket Notifications (510(k)s). This workshop will be beneficial to those with job functions in regulatory affairs, clinical affairs, research and development, and quality assurance. Learn more.

Technical Writing for Regulatory Submissions

AdvaMed SmartBrief | Feb 04, 2016

March 8 | Sunnyvale, Calif.
Technical writing is not a skill anyone is born with, nor is it something that is typically taught in school. Tailoring your writing for inclusion in regulatory submissions uniquely refines the complexity of this work. Many scientists, engineers and regulatory specialists will model their writing off of previous work they've read -- ultimately dooming themselves to repeating the mistakes of their peers. Inevitably, this practice sends the organization on a continuous race to the bottom. This course will specifically address the needs of medical device companies interested in avoiding interruptions in regulatory review and delays in regulatory approval due to poor or incomplete presentation of engineering information and analysis. Learn more.

IDE Submissions Workshop

AdvaMed SmartBrief | Feb 03, 2016

Feb. 24 | Irvine, Calif.
During this interactive workshop, FDA staff (invited) and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. You'll learn how to make the best use of pre-submission meetings, components of a successful IDE submission, common errors and deficiencies in an IDE application, and more. Learn more.

510(k) Submissions Workshop

AdvaMed SmartBrief | Feb 03, 2016

Feb. 22-23 | Irvine, Calif.
FDA (invited) and industry experts are coming together to teach you the basics of 510(k) submissions. You'll learn the FDA's updates to the 510(k) process, considerations for determining a product's regulatory route to market, factors to consider when planning and assembling a 510(k) submission, and tips and hints on interacting with FDA during the 510(k) review process. Learn more.

California Proposition 65 Webinar: What to Know and What's Ahead

AdvaMed SmartBrief | Feb 02, 2016

Feb. 23 | Webinar
During this one-hour webinar, California Proposition 65 experts will provide an overview of the law, including recently proposed amendments, and its implications on medical device manufacturers. The experts will also discuss potential legal liability and litigation risks, and provide a detailed overview of the treatment of BPA. A Q&A session will immediately follow the presentation to address attendee comments and questions. Learn more.

PMA Submissions Workshop

AdvaMed SmartBrief | Feb 02, 2016

Feb. 25-26 | Irvine, Calif.
Completing the MTLI set of interactive submissions workshops, senior industry experts and FDA staff (invited) will lead you through the strategic considerations and practical steps of filing a premarket approval. You'll learn tips for developing your submission strategy, best practices to help prepare for an inspection, and more. Learn more.

AdvaMed Women's Executive Network Conference

AdvaMed SmartBrief | Feb 01, 2016

June 15 | Washington, D.C.
Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. In this unique one-day event, we'll feature a range of executives from across the medical device and corporate world to discuss various issues pertaining to gender diversity in the leadership and executive ranks of our industry. We welcome men and women of all levels to participate in this highly interactive and discussion-based event. Learn more.

Women's Executive Network Webinar: Executive Profiles

AdvaMed SmartBrief | Feb 01, 2016

March 29 | Webinar
During the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy Meritz, will be profiled. You'll learn what has shaped their careers, what and who has helped along the way, and what advice they would pass along to the current and next generations of industry executives. Learn more.

AdvaMed-BRG Compliance Executive Speaker Series

AdvaMed SmartBrief | Jan 29, 2016

April 13, Irvine, Calif. | May 18,  Sunnyvale, Calif. Sept. 14, Chicago, Ill. | Oct. 26, Boston, Mass.
AdvaMed and BRG are excited to announce the inaugural Compliance Executive Speaker Series. We'll be coming to an area near you with a series of one-day, highly interactive small-group sessions that will deliver in-depth content, expert industry speakers, case studies and best practices on emerging compliance issues facing the medical device industry. Learn more.

Tax Extender Legislation Webinar

AdvaMed SmartBrief | Jan 28, 2016

Feb. 2 | Webinar
On Jan. 1, the suspension for the 2.3% excise tax on medical devices went into effect. Do you understand the implications? Is your company prepared to deal with what's next? During this one-hour webinar, representatives from AdvaMed's Government Affairs, General Counsel and outside tax counsel will cover the details you need to know about the tax suspension and the full provisions of the ACA. This event is free for all AdvaMed members. Learn more.

9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference

AdvaMed SmartBrief | Jan 25, 2016

May 3-4 | Arlington, Va.
This annual workshop brings together leading authorities from the FDA, industry and academia to address statistical topics through two tracks: therapeutic device and diagnostics. Robert M. Califf, deputy commissioner for medical products and tobacco for the U.S. Food and Drug Administration, will be the keynote speaker. Learn more.

Statistical Methods in Economic Evaluations Workshop

AdvaMed SmartBrief | Jan 22, 2016

May 2 | Arlington, Va.
Economic evaluations play an integral role in informing health care policy decisions. These studies often rely on data from clinical trials, prospective registries and secondary data. The availability of patient-level data allows analysts to apply conventional and innovative statistical methods to patient-level data. Using examples, the faculty will examine statistical approaches that address common features of resource use and cost data, including distributional characteristics, censoring, hierarchical data structures and potential confounding. Additional statistical issues that arise when combining patient-level estimates of costs and effectiveness will also be discussed. Learn more.

Medical Device Complaints, MDRs & Reports Workshop

AdvaMed SmartBrief | Jan 22, 2016

April 27-28 | Washington, D.C.
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? Industry experts and FDA staff (invited) will explore these issues during this two-day workshop. Learn more.

The Best of AdvaMed 2015 -- The MedTech Conference: A Focus on Industry Innovation

AdvaMed SmartBrief | Jan 12, 2016

Feb. 9-10 | AdvaMed Headquarters, Washington, D.C.
The annual AdvaMed MedTech Conference is the leading medtech event in North America and in 2015, brought together more than 1,000 companies in a uniquely multifaceted environment. AdvaMed 2015 provided key perspectives to advance industry discussion through detailed panel sessions, executive forums and more. Did you or a colleague miss this "must-attend" event? We'll be hosting an abbreviated "Best of AdvaMed 2015: The MedTech Conference" event, focusing on industry innovation, where we'll bring together a sample of some of the 2015 Conference's most popular panel discussions. Learn more.

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