Events

Conferences

December 10-12, 2018

Design of Medical Devices Conference, China 2018
Location: Beijing Int'l Convention Center
Beijing, China

The University of Minnesota Earl E. Bakken Medical Devices Center, along with its partner Neos Discovery Capital, held the first ever DMDC in November 2017 with important sessions held by the China FDA, US FDA, leading med device companies, and leading academic institutions. This year the event is being held Dec 10 – 12 at the Beijing International Convention Center in Beijing, China.

The event will once again feature live surgery, input from leading FDA officials (China and USA), discussions on the merging of devices with AI, new technology applications, the applications of Med Devices to world and rural health, and similar topics. This year we are expect 1,000 attendees in Beijing with exhibitors and contributors from many nations. A strong delegation from Africa is expected at the event. The DMDC event is quickly becoming a strong international meeting place for the Med Device Industry, Researchers, Regulators, and Academia. The 2017 participants included Abbott, Boston Scientific Corporation, Medtronic, Johnson & Johnson, Worrell and many others.

Register online today www.dmd.umn.edu/china/registration

December 11-12, 2018

ICH E6 GCP Interactive Workshop
Raleigh, NC

For clinical trials, it’s a new ball game. The ICH E6 (R2) guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.

FDAnews has teamed up with Technical Resources International Inc. to present a two-day hands-on workshop aimed at helping you understand and comply with new ICH E6 (R2) rules. Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Have you established your program yet? Is your maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:

  • What the new guidelines require
  • How to establish your program step-by-step
  • Critical elements of starting your program: A walk-through
  • How to conduct risk assessment at both system and clinical-trial levels
  • Evaluating the risks: Your options
  • Risk mitigation and reporting strategies
  • Common pitfalls and how to sidestep them
  • And much more!

Your leader, Dr. Susan Leister, Director-QA of Technical Resources International, is a seasoned veteran of the clinical-trial wars. She will be joined by special guest speaker, Linda Sullivan, Executive Director, Metrics Champion Consortium. You’ll receive a binder of course and reference materials you’ll turn to long after the workshops have ended, including:

  • The revised Guidance along with all applicable regulations
  • Illuminating articles and white papers on risk management
  • Sample tools and templates
  • Activities
  • PowerPoints and slides
  • And more besides!

For details and registration, Click Here

December 12-13, 2018

Building A World-Class Advertising And Promotion Review Program
Raleigh, NC

FDA marketing scrutiny no longer is limited to magazine and TV ads. Now the agency is poking around, checking signage in tradeshow booths ... checking in on Twitter, YouTube and Facebook ... and listening to the physicians and other healthcare professionals you've paid to speak or train.

In 2016 the Office of Prescription Drug Promotion issued 11 enforcement letters. A 20 percent increase from 2015. Six of those 2016 letters were issued in December alone. What is the meaning of OPDP’s recent upswing in enforcement?

Face it: You need help. Not with creating better ads and promotions — you already know how to do that — but for making sure your promotional activities aren't magnets for warning letters. Come to Raleigh in December for two days of intense learning. You'll arrive back home with a bag full of tricks and tips to keep all your marketing efforts squeaky-clean.

  • Understanding Pre-Approval Communications: Don't get on the FDA's or SEC's radar screens before your product is even approved. Learn how to properly disclose information and remain in compliance.
  • How to Maximize Disease Awareness Communications: Take away valuable tips and tricks for using disease awareness communications pre- and post-approval.
  • Hurray! You're Approved: Build the most aggressive — but compliant — campaign from first day of approval to commercial launch.
  • Assuring Your Promotions Meet FDA Off-Label Standards: Successfully navigate 4 major traps that can earn you a warning letter fast.
  • Itching to do More with Social Media?: Discover how to get your message out there ... without crossing the line.
  • Understanding Off-Label Communications: How will the November 2016 FDA memo and January 2017 FDA guidance affect your communications?

For details and registration, Click Here

April 15-18, 2019

18th Annual Design of Medical Devices Conference
Graduate Minneapolis & McNamara Alumni Center
Minneapolis, MN

The University of Minnesota’s Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering, and the Department of Mechanical Engineering presents the 18th Annual Design of Medical Devices Conference, April 15-18, 2019. The world's largest medical device conference will be held at Graduate Minneapolis & McNamara Alumni Center, located on the University of Minnesota Twin Cities Campus. The DMD Conference brings together medical device designers, manufacturers, researchers and representatives from academia and the public sector.

Conference Goals

  • Provide a national forum to bring together world-class medical device designers, researchers, manufacturers, and the public sector to share perspectives and innovations in medical device design,
  • Showcase the University of Minnesota as a leader in the medical device community, and
  • Raise funds from corporate sponsorship to support medical device education at the University of Minnesota
Call for Papers

The DMD 2019 Conference seeks original papers that demonstrate new technologies and applications in the field of medical device design. Submissions from academic and industry researchers, clinicians and practitioners are encouraged. Papers should present an unbiased description of an experiment, product or business method related to medical devices. Repeated references to branded products or trade names, or excessive use of corporate logos or trademarks in illustrations is discouraged. Authors of contributed papers are likely to be asked to serve as reviewers.

A number of papers will be selected to be presented in one of the Advances in Medical Devices sessions and ten papers, describing medical device designs with a potential for commercialization, will be invited for participation in the Three-in-Five Competition.

All accepted papers will be published in the 2019 Proceedings of the Design of Medical Devices Conference in the ASME Digital Collection. DMD Conference registration and presentation of the paper in the conference poster session is required for publication of the paper.

High-quality accepted papers will be flagged in the review process and those authors will be invited to submit a longer version of their work for publication in the ASME Journal of Medical Devices. These papers will undergo an expedited review process, handled by the JMED editors.

November 1, 2018 - Draft Papers Due

Registration

Registration opens January 1, 2019! Early Bird Deadline is March 10. Complete registration information can be found at www.dmd.umn.edu/registration

Sponsorship Opportunities Available

The mission of the Design of Medical Devices conference is to facilitate collaboration between academia and industry. Exhibit Space is limited. Deadline to sponsor is March 1, 2019. To learn more, contact Jenny Holden, Conference Administrator at rampi002@umn.edu.

For more information, please visit www.dmd.umn.edu or contact dmdconf@umn.edu

Training Programs

Phlebotomy Training in 2 days!


Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!

www.phleb.com/privategroups

Webinars

December 5, 2018

FDAnews/CenterWatch Webinar

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies
DAIA Will be a Game-Changer

1:30 p.m. - 3:00 p.m. EDT

In August 2018, the FDA provided feedback on a draft of the Diagnostic Accuracy Innovation Act (DAIA), which Representatives Larry Bucshon and Diana DeGette publically released last year.

If passed in the next session of Congress, the current draft of the DAIA will impact FDA regulation of laboratory developed tests (LDTs), in vitro companion diagnostic devices, and targeted drug and biologic therapies. DAIA provides a predictable and timely path to market for these important clinical tests. Will it pass next year? Hill insiders say yes. Why? Because for the first time ever, FDA and Congress agree on its key elements.

And really, when does that happen in Washington these days?

Based on industry reaction — and Congress’ expressed eagerness to resolve this issue — it’s likely that next year this legislation, in one form or another, will significantly change the regulations of LDTs, companion diagnostics and targeted therapies.

It’s not too late to influence the final form of this legislation, and it’s definitely not too soon to start preparing for the future. If you’re in LDT space, and you want your legislators in the next Congress and FDA to know what you think about the current plan, this is your best chance to make your voice known. In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. You’ll learn the following:

  • Current regulatory landscape for LDTs and in vitro companion diagnostics
  • Breakdown of the DAIA — how the legislation would change FDA’s oversight of in vitro diagnostic products, and would affect pre-and post-market requirements
  • How the DAIA defines low-risk and high-risk test and how it affects your regulatory burden
  • Under what circumstances an existing product will need to seek marketing approval from FDA
  • What enforcement powers will FDA be granted — such as the ability to demand a product recall
  • The implications for targeted drug and biologic therapies — such as when an in vitro companion diagnostic must be approved by FDA before it will approve the targeted therapy

Register today to understand what you should be doing to prepare for these coming changes, including identifying products that may fall under DAIA and planning to obtain the data needed to support a marketing application.

Who Will Benefit
  • Quality and regulatory professionals in drugs, biologics, lab testing, companion diagnostics, and gene therapies.

    REGISTER NOW

December 6, 2018

FDAnews/CenterWatch Webinar

Expediting the Generic Drug Approval Process
FDA’s New Initiatives on Drug Competition

1:30 p.m. - 3:00 p.m. EDT

The FDA announced its Drug Competition Action Plan a year ago. And the agency continues to announce new guidances intended to speed up generic drug approvals. The FDA recently announced a guidance to enhance filing review requirements.

A record number of generic drugs have been approved this year. With the new expediting process, Commissioner Gottlieb believes that record highs will be achieved year on year.

Are you — and your new generic — ready for the expedited pathway?

In 90 fast-paced minutes attorneys Chad Landmon and Suchira Ghosh of Axinn, Veltrop & Harkrider LLP will methodically lay out the various policies, how they’ve been implemented, how you can engage with them and identify possible issues. You’ll learn the following:

  • The new pathways to expedite approval of generic drug applications, including 180-day exclusivity
  • Best practices to obtain exclusivity and the top don’ts for losing exclusivity
  • Recent FDA policy statements and guidance on generic drugs and their impact on regulatory and quality professionals
  • Substantive changes to REMS standards that impact ANDAs
  • FDA’s other policy initiatives: prioritizing generic drug review; spur generic approvals to increase competition and lower cost, while maintaining quality
  • How the real cost saving benefit provided by generics doesn’t come into full effect until there are multiple generic versions available
  • Register today to gain a clearer understanding of the various FDA initiatives surrounding generic drug access and how to best navigate these changes.
Who Will Benefit
  • Regulatory Counsel
  • Regulatory Affairs
  • Safety and Pharmacovigilance
  • REMS manager
  • Legislative and Policy

REGISTER NOW

December 12, 2018

FDAnews/CenterWatch FREE Webinar

Transforming Quality Management with Modern Technology

11:00 p.m. - 12:00 p.m. EDT

Make faster and more informed quality decisions and promote faster innovation with modern solutions.

Digitalizing operations with cloud is improving key areas including automating batch disposition and release, enabling intelligent complaint processing, and allowing more effective supplier collaboration and technology transfers.

Join the webinar to gain a new perspective on quality management and how technology:

Supports the shift from compliance to product and patient focus Enables greater insight and decision-making Seamlessly engages stakeholders across the development lifecycle Transforms business process for real-time responsiveness

Who Will Benefit
  • VP/Director of Quality and Compliance (QA or QC), Quality Systems
  • VP/Director of Information Technology, Quality Management Systems, Quality Systems
  • VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
  • Document/Records Managers/ Directors
  • Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
  • IT System Administrators
  • Quality Training Coordinator

REGISTER NOW

December 18, 2018

FDAnews/CenterWatch Webinar

Medical Device Voluntary Malfunction Disclosure Regulation
Are You Up to Date on the Latest Developments?

11:00 p.m. - 12:30 p.m. EDT

The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report.

Over the course of 90 fast-paced minutes, Stephanie Resnik and Christopher Hanson — associates at Covington & Burling LLP, Washington, DC — will discuss which products are covered, how the program will help increase efficiency and whether it makes sense to take part in the program. You’ll learn:

  • Background of the Voluntary Malfunction Summary Reporting Program including:
    • Origins of the program
    • FDA’s intentions in establishing the program
    • Types of manufacturers, devices, and events eligible to participate in the program
  • How the Voluntary Malfunction Summary Reporting Program differs from individual malfunction reporting
  • Benefits to device manufacturers including the efficiency advantages offered by the program
  • Conditions under which the program is not available to manufacturers
  • And much more…

Join us on December 18 and discover the advantages of participating in the Voluntary Malfunction Summary Reporting Program

Who Will Benefit
  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners

REGISTER NOW

December 18, 2018

FDAnews/CenterWatch Webinar

Medical Device Cybersecurity Risks & Best Practices
Navigating the Nuanced Cyber Regulatory Waters

1:30 p.m. - 3:00 p.m. EDT

Smart medical devices have underlying cybersecurity and privacy risks. They are also top targets from a host of global attackers from nation states to sophisticated criminal gangs. The health sector — including medical device manufacturers as well as pharmaceutical and biotech companies — faces uncharted regulatory and liability risks.

FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies.

Over the course of 90 fast-paced minutes, Ms. Krayem will move from the Cybersecurity Executive Order 13800 to HIPAA, Homeland Security and more:

  • Cybersecurity-triggered changes in the interpretation of HIPAA, and enforcement by the HHS Office of Civil Rights, as they affect quality and regulatory matters
  • Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms
  • Homeland security: How DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers
  • FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities, and regulation of companies
  • The Cybersecurity Information Sharing Act (CISA) and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”
  • New international privacy and cybersecurity laws impacting the health sector
  • And much more

With U.S. agencies — FDA, HHS, DHS — all at work on new sector risk bulletins and re-evaluation of current rules such as HIPAA, and global regulators equally involved, this is a pressing matter. Address it now, by committing an hour and a half of your time to this timely learning session

Who Will Benefit

Cybersecurity is a multi-discipline activity, so team participation in the presentation is important. Team members include:

  • Design Engineers
  • Software Engineers
  • Software Validation Specialists
  • Risk Managers
  • Complaint Managers
  • Complaint Analysts
  • Regulatory Affairs Managers
  • Submission Specialists

REGISTER NOW