Events

Conferences

September 10-12, 2018

MASTERING EU MEDICAL DEVICE REGULATION
Philadelphia, PA

Devicemakers face an array of tough new rules as the EU phases in the new Medical Device Directive (MDR) — rules that will change how you do business everywhere in the world.

  • Your entire product portfolio will need re-approval
  • Standards such as the ISO 13485:2016, changed once already, will change again to align with the new MDR
  • Turnaround time for incident reporting will drop from 30 to only 15 days

This barely scratches the surface. The MDR, which replaces the existing Medical Device Directive (MDD), is 175 pages (vs. 60) of new provisions ... changes to existing ones ... inclusions ... and exclusions. And confusion abounds: Rules for accrediting Notified Bodies (NB) aren’t even final yet, for example.

You may think you have lots of time to comply but you don’t: Fewer than two years. Here’s what to do NOW. Mark your calendar for an intense hands-on training session in Philadelphia, Tuesday-Thursday, Sept. 10-12. Over the course of two days understanding and implementing the new MDR ­— plus a third add-on day focusing on post-market activities — you’ll discover:

  • The new MDR classification system: How to apply it
  • Conformity assessment paths: How they apply to specific devices
  • Annex I requirements: How to document compliance
  • Technical documentation requirements in Annex I and Annex II
  • Unique Device Identification: The EU approach
  • Economic operators and their relationship to you
  • Notified Body: What it is, what it does
  • And MUCH more!
  • Many workshop exercises will be tailored to your specific products. You’ll receive detailed checklists to help classify devices, apply Annex I requirements and conduct internal quality audits, as well as:
    • A map from the MDD Annex I to the MDR Annex I
    • A workbook of device attributes used for UDI implementation

    For details and registration, Click Here

  • September 27, 2018

    Emerging Biopharmaceutical Therapies
    Washington, DC

    The science and technology of drug and biologics development is moving faster than at almost any time in modern history, and the FDA is struggling to keep pace.

    It must adapt a regulatory framework designed for conventional pharmaceuticals to the new world of gene therapy, personalized medicine and much more. And by hook or by crook, it’s doing so.

    The questions you face are: How? How soon? And what impact on your profits?

    Come to Washington for the answers. It’s an all-day conference with one of the Capital’s top FDA lawyers, Christina (Chris) Markus Esq. of King & Spalding LLP. Over the course of a full day in K&S’s well-appointed K Street offices, she’ll spell out the novel issues and the regulatory revolution they’re triggering … and help you develop a coping strategy. You’ll discover:

    • Red flags: Product characteristics that raise regulatory classification and evaluation challenges
    • Novel products: Why they may not fit into current regulatory regimes
    • How precedent applies: Recent laws, FDA guidances and review precedents
    • FDA interpretations: How the agency is adapting existing precedents to novel products
    • Informed consent: How it may change to enable research use of biospecimens, including recent amendments and practical risks associated with consent
    • Product approvals: How recent regulatory actions may affect them
    • Tricks of competitors: Approval strategies that are working for others
    • Capitalizing on incentives: Incentives exist for product development and may facilitate regulatory interactions
    • Practical take-home strategies: Tips for getting what you need from the FDA
    • And MUCH more!

    For details and registration, Click Here

    October 9-10, 2018

    Medical Device Complaint Management
    Waltham, MA

    When it comes to QMS and complaint management, device and diagnostics firms face a welter of confusing, sometimes conflicting regulations from the FDA, the EU and Canada. And you don’t dare let your guard down, at the risk of a warning letter … or worse.

    FDAnews and OMBU Enterprises LLC have teamed up to help you untangle these vexing problems. It’s a roll-up-your-sleeves interactive workshop in the heart of Boston, conducted by top-rated presenter Dan O’Leary. Over the course of two full days of learning and networking, jam-packed with case studies and exercises developed specially for this workshop, you’ll gain insight into how to keep the regulators happy from here to Brussels and beyond:

    • The regulators: The FDA, Canada, the EU current state and the EU future state … how they’re similar, how they differ
    • The role of QSR, ISO 13485:2016, ISO 14971:2007, and national and regional variants
    • The many definitions of complaints: And their implications
    • Warning letters: What they teach you
    • Process flow and decision points for U.S., EU and Canadian regulators
    • Adverse event reporting: Decisions and timelines
    • Trend reporting to regulators: Understanding the systems
    • Field actions and associated regulatory reports: How to spot the triggers
    • Design changes that trigger the need for updated submissions
    • Recognize when a design change triggers an updated regulatory submission
    • QSIT and the MDSAP Audit Model: How regulators use them
    • And MUCH more!

    For details and registration, Click Here

    October 23-25, 2018

    FDA Inspections Summit - 13th Annual
    Bethesda, MD

    Mark your calendar for the 13th Annual FDA Inspections Summit taking place Oct. 23-25, 2018 in Bethesda, MD. The Summit is THE place to hear from current and former FDA officials and top industry experts. The program is coming together nicely and will include specialized tracks for:

    • Medical Devices
    • Pharmaceuticals
    • Clinical Trials

    Testimonials from Past Attendees:

    • “Great discussion and knowledgeable panel. I enjoyed having the FDA give examples in their own words…” Dan Lewis, Site Quality Leader, P&G
    • “The panels were great. Very informative and great discussions.” Nancy Carranza, Vice President, Operations, GSMS, Inc.

    For details and registration, Click Here

    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

    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

    August 22, 2018

    A CenterWatch/FDAnews Webinar

    Corporate Compliance & Liability: What Medical Product Professionals Need to Know

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

    It’s easy to lose sight of the big picture. But you do so at your peril.

    Take violations. You probably worry about warning letters and Forms 483, never giving a thought to criminal charges. But they happen too, more often than you think.

    FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble.

    Your presenters are Mark C. Levy Esq., and Asst. U.S. Atty. Elizabeth Abrams Esq. They’ll show you both sides of the law — defense and prosecution — in a must-attend webinar that could pay off for many many years. Among things you’ll discover:

    The Big Picture:

    Justice Dept. policy on compliance programs, a process that has direct impact on regulatory and quality professionals The FDCA and the False Claims Act: Enforcement and the impact of whistleblowers Criminal and civil liability: Strategies to avoid both The Fine Points:

    Process validation [21 CFR 820.75(a)]: Building a system that works Purchasing controls [21 CFR 820.50]: Keeping your supply chain clean Conforming products [21 CFR 820.90(a): Conforming to specified requirements We all get stuck in a hole sometimes. In the day-to-day focus on the FDA, it’s easy to lose sight of how other agencies may be helping — or hurting — you. Are you aware of the latest Justice Dept. guidance on what makes an effective compliance program? This is a rare opportunity to discover … to climb out of that hole for a look around.

    Who Will Benefit

    Drugs, devices, diagnostics: Every FDA-regulated health sciences organization can benefit:
    • C-Suite
    • Legal affairs
    • Regulatory/compliance
    • Quality control
    • Marketing/sales
    • Strategic planning

    REGISTER NOW

    August 23, 2018

    A WCG | CenterWatch FREE Virtual Roundtable

    Clinical Trials in the Precision Medicine Era
    New Techniques, New Complexity

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

    Drug pipelines are changing and sponsors are focusing on highly targeted therapies. To do that effectively, investigators must rely on genetic testing.

    But that’s easier said than done.

    Historically a Phase III trial would collect about a million data points; with genetic testing that’s increased to 3 to 5 million data points. And to enroll the right patients, genetic testing often must be done before someone enters a trial.

    That volume of highly complex data leaves many investigators struggling to explain results to patients. It can be daunting.

    That’s where a new partnership between WCG and InformedDNA can help you.

    Mark your calendar for Aug. 23 when CenterWatch brings you a FREE virtual roundtable, featuring WCG’s Chief Medical Officer Lindsay McNair, InformedDNA’s Karmen Trzupek and Jill Johnston of WCG’s Site Management Group.

    These three highly engaging genetic and trial experts will bring you the their best advice for thriving in this brave new clinical trial world.

    REGISTER NOW

    September 12, 2018

    A CenterWatch/FDAnews Webinar

    Top Tips for Establishing Device Supplier Quality Metrics: Develop a World-Class Program to Boost Productivity & Compliance

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

    Increased emphasis on risk management processes… investigators reviewing objective evidence… short time to market… internet publicity…

    All of this means that you need to take your supplier quality metrics to the next level.

    The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes.

    How do you get there?

    That’s the specialty of consultant Richard A. Sena. To discover his top tips and techniques for establishing supplier quality metrics, sign up for this webinar now. You’ll discover:

    • Acceptance percentage vs process yield vs first pass yield vs scrap
    • Training man-hours recordkeeping and analysis for self and suppliers
    • Audit man-hours support — preparation and post-audit efficiency
    • Product or IT process change metrics and user effectiveness
    • Consumer/commercial product “Ease of Use” metric
    • Recall effectiveness measures within the distribution process
    • Don’t miss out on your chance to identify unseen risk prevention methods and
    • customer/audit process improvement opportunities not currently visible through top level metrics. Take your supplier quality metrics to the next level.

    Who Will Benefit

    This session is well suited to both small-to-medium-sized devicemaking firms as well as large global firms. Specific job titles include:
    • Supply Chain Management
    • Supplier Quality Engineering
    • Operations Management
    • New Product Development
    • Systems Development
    • Regulatory/Compliance
    • QA/QC
    • New Business Development
    • Human Resources

    REGISTER NOW

    September 17, 2018

    A CenterWatch/FDAnews Webinar

    Complying with Advertising & Promotion Requirements: Top Tips for Conforming to FDA, FTC, NAD, BBB and State Mandates

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

    When it comes to promoting drugs and devices, everyone wants in.

    From Washington (the FDA, the FTC) to the states (attorneys general) to City Hall, dozens of agencies take an interest in the way you advertise and market your products. So do private-sector watchdogs including Better Business Bureaus and the NAD. Each of these bodies scrutinizes different things. Each has its own way of operating.

    Take a crash course in dealing with this panoply of enforcers. Mark your calendar for Monday, Sept. 17, when FDAnews presents a 90-minute webinar featuring two Washington lawyers with years of experience dealing with regulation of health science product marketing. You’ll discover:

    • What to expect from FDA, FTC, State Attorneys General, Better Business Bureau, and NAD
    • Trigger points for enforcement for each agency
    • Trends in enforcement among the various agencies, including important actions against both device and drug manufacturers
    • Top tips for avoiding legal liability
    • Top tips for remedying enforcement problems including specific do’s and don’ts for dealing with government and non-government agencies
    • And much more!
    • It’s a long time since drug and device advertising was illegal. Today, your competitors do it and so must you. Here’s how to do it right.

    Who Will Benefit

    Drug and device makers will benefit, as well as makers of dietary supplements and health-related products such as functional foods and cosmetics. Consider participating if your job title includes:
    • Sales/marketing/advertising
    • C-suite executives
    • Strategic planning
    • Regulatory/compliance
    • Legal counsel

    REGISTER NOW

    September 19, 2018

    A CenterWatch/FDAnews Webinar

    Medical Device Software and Risk Management

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

    FDA’s QSR section on design validation has two interlocking requirements. One requires software validation and the other requires risk management. Interesting issues arise when both apply to the same medical device. And while ISO 13485:2016 doesn’t have an explicit reference to software in a medical device, the same issues apply there too.

    It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. That’s why FDAnews has reached out to Dan O’Leary, our go-to expert on medical device compliance, to simplify a knotty area of FDA and international device regulation.

    Over the course of 90 minutes, Mr. O’Leary will break complex compliance issues down into simple English. Get ready for mastery of:

    • FDA-CDRH guidance documents related to software
    • Interrelationships among software development, pre-market submissions and post-market activities
    • Determining the Level of Concern for a software device
    • ISO 14971:2007: Understanding its role as the overarching risk management document
    • IEC 62304:2006 & A1:2016 and its role as a software process standard
    • The Software Safety Classof a medical device and how to determine it
    • IEC/TR 80002-1:2009: How to use it
    • And MUCH more!

    FREE Bonus Material! Participants receive an Excel workbook that helps determine a) the Level of Concern and required documentation and b) the Software Safety Class and associated process steps.

    Medical device risk management — specifically device software risk management — calls for a solid understanding of the documentation framework. This can be challenging because it includes elements from both the FDA view and the international standards view. It’s technical, sure … but all the more reason you must get it right. Here’s the moment to do just that.

    Who Will Benefit

    Software development and risk management are best accomplished through a team. Team members who ought to consider attending include:
    • Software managers and engineers
    • Software quality specialists
    • Risk managers
    • Cybersecurity specialists
    • Regulatory submission managers and specialists

    REGISTER NOW