ADVAMED Association News
Diagnostics Submissions Workshop
AdvaMed SmartBrief | May 29, 2012
Tuesday, June 12 – Wednesday, June 13
L'Enfant Plaza Hotel, Washington, D.C.
Get guidance from industry and government speakers on key diagnostics
issues in an interactive day-and-a-half program. You will participate in sessions ranging from a current diagnostics overview, what it takes to create a quality 510(k) and PMA submission, CLIA waivers, tips and strategies for submissions, and interactive industry case studies. Through educational sessions and hands-on training, network and learn from your peers about these key focus areas in diagnostics.
Visit MTLI online for more information.
Supplier Controls: Regulations and Best Practices Virtual Meeting
AdvaMed SmartBrief | May 29, 2012
Wednesday, June 6
Virtual Conference, 10:00 a.m. - 4:00 p.m. EST
Recent enforcement actions and several product-related tragedies
highlight the risks of inadequate vendor selection and oversight, poor
communication, misunderstanding of regulations and responsibilities, and
a failure to apply the same
risk-based approach to supplied components and services that one
applies to one's own products and processes. This virtual conference
brings together leading authorities from the FDA, industry and critical
component suppliers to discuss strategies and best practices
for instituting and maintaining a robust and responsible supplier
control program.
Visit MTLI online for more information.
Join the AdvaMed-MTLI LinkedIn group!
AdvaMed SmartBrief | May 25, 2012
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page.
Premarket Approval (PMA) Submissions Workshop
AdvaMed SmartBrief | May 24, 2012
Thursday, Oct. 18 – Friday, Oct. 19
Sheraton Crystal City, Arlington, Va.
Completing the MTLI set of interactive submissions workshops, 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 the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. Visit MTLI online for more information.
Investigational Device Exemption (IDE) Submissions Workshop
AdvaMed SmartBrief | May 24, 2012
Wednesday, Oct. 17
Sheraton Crystal City, Arlington, Va.
MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, 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. Visit MTLI online for more information.
Medical Device Reimbursement Workshop
AdvaMed SmartBrief | May 23, 2012
Tuesday, Oct. 16 – Wednesday, Oct. 17
Sheraton Crystal City, Arlington, Va.
AdvaMed MTLI’s workshop for medical technology reimbursement professionals will provide the road map to successfully navigate the many potential pitfalls. After an overview of reimbursement issues, the workshop will drill down to coding systems, technology assessments and differences in inpatient and outpatient payment systems. Hear from experts on how to negotiate CMS coverage. Learn how to plan for the new health care reform landscape, deal with comparative effectiveness and manage international reimbursement. Visit MTLI online for more information.
510(k) Submissions Workshop
AdvaMed SmartBrief | May 23, 2012
Monday, Oct. 15 – Tuesday, Oct. 16
Sheraton Crystal City, Arlington, Va.
This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, 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 the FDA during the review process, and dealing with post-clearance issues. Visit MTLI online for more information.
Medical Device Workshop on FDA Inspections, Warning Letters & CAPA
AdvaMed SmartBrief | May 21, 2012
Tuesday, May 22 - Wednesday, May 23
Sheraton Crystal City, Crystal City, Va.
The percentage of CAPA system deficiencies in FDA warning letters has
increased in the past five years. This conference will provide you with the
tools to avoid warning letters, enable you to demonstrate your
compliance initiatives and teach
you how to respond to a warning letter. Learn how properly to integrate
and implement your CAPA program to improve internal processes and
products and better achieve business objectives. Network with a
distinguished panel of experts for an in-depth examination
of what CAPA is, how the concept has evolved and whether it
accomplishes what industry needs and what FDA expects.
Visit MTLI online for more information.
See AdvaMed-MTLI's schedule of courses
AdvaMed SmartBrief | May 09, 2012
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses here.
Getting to Market in the EU: Making Sense of the Many EU Requirements for Clinical Data
AdvaMed SmartBrief | May 07, 2012
Tuesday, May 8
Webinar, 12:00 p.m. - 1:00 p.m. EST
With the recent medical device scandals in the EU, the commissioner has publicly requested tighter controls. Clinical evaluations are an area that have come under scrutiny in recent years, resulting in multiple changes in the regulations and standards, and creating additional potential consequences for manufacturers who are selling legacy devices or planning to introduce new models in the EU. Device manufacturers need to know what the new requirements are and how they may affect existing and new product certifications. In this live webinar, participants will have the opportunity to hear from the expert presenter, Dr. Dannhorn, on strategies for meeting the new requirements and have the opportunity to ask questions. Visit MTLI online for more information.
Medical Device Workshop on FDA Inspections, Warning Letters and CAPA
AdvaMed SmartBrief | May 02, 2012
Tuesday, May 22 - Wednesday, May 23
Sheraton Crystal City, Crystal City, Va.
The percentage of CAPA system deficiencies in FDA warning letters has
increased in the past five years. This conference will provide you with the
tools to avoid warning letters, enable you to demonstrate your
compliance initiatives and teach
you how to respond to a warning letter. Learn how properly to integrate
and implement your CAPA program to improve internal processes and
products and better achieve business objectives. Network with a
distinguished panel of experts for an in-depth examination
of what CAPA is, how the concept has evolved and whether it
accomplishes what industry needs and what FDA expects.
Visit MTLI online for more information.
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