August 8-10, 2018

Waltham, MA

The clinical trials world is going back to school. New ICH E6 (R2) guidelines require trial sponsors to institute risk assessment at both the system and clinical trial levels and require drug and biologics makers to qualify vendors.

You can get all the training you need to meet these challenges with three days of hands-on workshops aimed at helping you understand and comply with new ICH E6 (R2) requirements. Teaming up with Technical Resources International Inc., we’ve created a pair of workshops that meet the needs of everyone along the clinical trials spectrum, from trial sponsors to trial operators and overseers. These workshops are aimed at every sector of the clinical trials world—drug and biologics makers; trial sponsors, trial sites and CROs; academic medical centers and IRBs—and the individuals who make trials happen:

  • QA/QC managers and staff
  • RA managers and staff
  • Compliance auditors
  • Manufacturing managers
  • Project managers
  • Senior managers
  • Supply chain and logistics managers

For details and registration, Click Here

September 10-12, 2018

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 Boston, 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

    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!


    July 17, 2018

    A CenterWatch/FDAnews Webinar

    Real-World Evidence
    Evaluating Benefit & Risk: What Devicemakers Need to Know

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

    The FDA is working with stakeholders across the medical device community to simplify the evaluation of new medical devices via Real World Evidence (RWE). A key component of that effort is the National Evaluation System for Health Technology, or NEST … and it could benefit you.

    Mark your calendar for Tuesday, July 17, when one of the agency’s RWE leaders gives you a view into FDA’s thinking and activities related to the use of RWE and the exciting potential for NEST.

    Owen Faris, Ph.D. is Director of the Clinical Trials Program in CDRH, FDA and has been a key leader in developing FDA’s approach to using RWE to inform regulatory decisions. Dr. Faris works closely with the NEST Coordinating Center so that FDA can partner with their efforts to build an RWE infrastructure that can help medical device developers, regulators, payers, clinicians and most importantly patients. Over the course of a fast-paced 90 minutes, he’ll bring you up to speed on how FDA views the current and potential uses of RWE for medical devices and what NEST may be able to do for you:

    • Real World Evidence (RWE): Why the FDA is promoting it to evaluate medical devices
    • How to support the NEST effort
    • Proof of concept as it applies to using RWE for device evaluation
    • Best practices and success stories
    • Your specific medical devices: How RWE and NEST can specifically apply to their development
    • And much more!

    NEST is seen as a real opportunity to find “better, faster, cheaper” approaches to evidence-based generation for device evaluation … and get your new products to market and to patients in less time.

    Who Will Benefit

    Devicemakers will benefit from this presentation in general. Job titles include but are not limited to:
    • Regulatory/compliance
    • Quality assurance
    • Manufacturing/GMP/cGMP
    • Supply chain executives
    • Auditors
    • Legal counsel


    July 18, 2018

    A CenterWatch/FDAnews Webinar

    eCTD Submissions — What You Need to Know to Comply with FDA Requirements Best Practices for Pharmaceutical Regulatory Professionals

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

    Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it.

    The time to prepare is now.

    Mark your calendar for Wednesday, July 18, and a presentation with consultant Antoinette Azevedo. You’ll discover what you need to know in 90 minutes flat:

    • How to avoid an RTR
    • Implementation roadmap: implementing the technical and organization components for eCTD success
    • Not spending a fortune: Best practices and options for producing your eCTD economically
    • Impact on CMO and CRO partners: How the eCTD format may affect them
    • Impact on other regulatory bodies: How the eCTD format may play in the EU and elsewhere
    • And MUCH more!

    The FDA has twice extended the deadline to start filing via eCTD, in recognition of the complexity entailed by this new process. A third extension is not likely. Discover what you need to know now.

    Who Will Benefit

    This presentation is directed at the drug and biologics community. It will be particularly useful to the following:
    • Medical Officers
    • Operations Officers
    • Regulatory Affairs
    • QA/QR/QC
    • Information Technology


    July 19, 2018

    A CenterWatch/FDAnews Webinar

    European Medical Device Regulations (EU MDR): Strategic Planning for the Coming Critical Changes

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

    Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations.

    The number of rules will increase from 18 to 22, dramatically impacting what quality and regulatory specialists do every day. Changes in classification rules will require manufacturers to confirm and update documentation to reflect the changes. And this just scratches the surface.

    Now, you can be prepared for all the changes with a new webinar/book combo offer from FDAnews. The webinar will provide clear explanations of the changes and gives you the chance to ask questions of an expert. The book supplies you with instructions and checklists to ensure you have done everything to ensure compliance! You can rest easy knowing that you understand all the changes, and have the documents you need to get your organization ready!

    James Pink has spent recent years immersing himself in the details and ramifications of this groundbreaking change. A device expert with extensive EU experience, Mr. Pink now brings his expertise to you.

    Mark your calendar for July 15 and 90 minutes of total immersion into the forthcoming changes. You’ll discover:

    • How the aforementioned rules increase, from 18 to 22, could affect your job
    • Documentation confirmation and updating: Specific changes you’ll be required to make
    • New separate software rules and what they say
    • Stricter requirements for implantable devices: The impact on quality and compliance
    • The consequences of delay: Sanctions you could face, markets you could lose
    • And much more!

    PLUS, you’ll receive a copy of our bestselling book: EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing. The report provides:

    • Definitions of key terms in the EU MDR
    • Knowing where to find specific requirements in the 150+ page regulation
    • Checklists that walk you through every aspect of manufacturing, safety and performance requirements
    • A training tool for employees new to the regulations
    • EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements is the tool that collects all the requirements, explains them and itemized them in an easy-to-use form to ensure compliance.

    The compliance deadline may be in 2020, but don’t kid yourself. The time to start preparing is right now. This webinar/book combo is the perfect start. Sign up today.


    July 26, 2018

    A CenterWatch/FDAnews Webinar

    Medical Devices and the FDA Reauthorization Act of 2017 What YOU Need to Know about FDARA

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

    Many devicemakers are viewing changes in the FDA Reauthorization Act of 2017 (FDARA) as a good thing, but the devil is in the details – and some of those details start taking effect next month. It’s time you got up to speed.

    FDAnews has reached out to a prominent member Jessica Ringel Esq. of King & Spalding LLP’s Washington office will offer explanations and insights.

    Over 90 fast-paced minutes, Ms. Ringel will bring you current on:

    • User fees: Changes you can expect in the fees your company pays for premarket submissions
    • FDA Inspections: Improvements anticipated in the inspections process
    • Certificates to Foreign Governments: How transparency in issuance and denials will increase
    • Pediatric device development: Specific FDA efforts to stimulate innovation in this area
    • What’s to come: New guidances, rules and reports anticipated from the agency in coming years
    • And much more!

    FDARA deadlines start hitting next month. Every devicemaker needs to know how the changes will cause benefit — or harm. Discover the details with one of Washington’s most knowledgeable presenters.

    Who Will Benefit

    Devicemakers, contract manufacturers, device specification develops and others subject to FDA device inspection, including specific job titles such as:
    • Quality personnel
    • Operations personnel
    • Regulatory personnel
    • Compliance personnel
    • Legal counsel


    August 1, 2018

    A CenterWatch/FDAnews Webinar

    Digital Health Tools: What YOU Need to Know Prepare now for the FDA’s Transformative Project

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

    The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well.

    With technology changing at lightning speed, there’s a lot to learn — and not much time to learn it. If you plan to reap the benefits, listen up.

    Mark your calendar for Wednesday, Aug. 1, when noted Washington FDA lawyer Bradley Merrill Thompson Esq. of Epstein Becker & Green P.C. outlines what the agency has done to date … and what it plans in the months to come. Over the course of 90 fast-paced minutes, he’ll fill you in on:

    • AI-powered clinical decision support software: How a recent FDA approval could affect you
    • The “Working Model”: The agency’s master plan for implementation
    • “Pre Cert 1.0”: What the first version may look like by late 2018
    • Drug development and digital tools: How the FDA is expanding opportunities and enabling patient-care innovations
    • Post-market surveillance: The varied roles smart tools may play
    • Cooperation with industry: Moves the FDA is making and mulling
    • Artificial intelligence: The FDA’s new approach
    • Pre-market digital safety: A new FDA program launches
    • Digital Health Incubator: Another new FDA program launch
    • And MUCH more!

    Smartphones and digital apps already have given consumers powerful tools to take control of their own health. The changes affecting the FDA-regulated manufacturing community will dwarf these. You need to get up to speed, and fast.

    Who Will Benefit

    This presentation is directed at makers of drugs, biologics, medical devices and combination products. It will be particularly useful to the following executives and professionals:
    • C-suite
    • QA/QR/QC
    • Regulatory affairs
    • Compliance affairs
    • Strategic planning
    • Marketing/sales
    • General counsel/outside counsel
    • Digital health consultants


    August 14, 2018

    A CenterWatch/FDAnews Webinar

    MDR Adverse Event Codes for Devicemakers

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

    What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A.

    What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter.

    All you gotta do is figure out how to use it … before the codes change.

    And that’s where FDAnews comes in. Mark your calendar for Tuesday, Aug. 14, when Dan O’Leary, one of our top-rated presenters, introduces you to the new coding regimen and walks you through eSubmitter’s twists, turns and tricks. In a fast-paced 90 minutes, you’ll discover:

    • Criteria for a mandatory medical device report
    • Required records and their content
    • The reporting system and associated acknowledgements
    • When codes apply in eSubmitter
    • The IMDRF harmonization plan: Which parts the FDA has adopted
    • Selecting the appropriate codes
    • Transition dates: Avoiding FDA rejection of obsolete codes
    • And much more!

    NEST is seen as a real opportunity to find “better, faster, cheaper” approaches to evidence-based generation for device evaluation … and get your new products to market and to patients in less time.

    Who Will Benefit

    Individuals involved in complaint management and adverse event reporting should sign up. In particular persons in the following job titles will benefit:
    • Quality Managers
    • Quality Engineers
    • Complaint Analysts
    • Adverse Event Managers
    • Medical Affairs Managers
    • MDR Investigators
    • MDR Preparers
    • MDR Submitters
    • IT Professionals who maintain eSubmitter


    August 15, 2018

    A CenterWatch/FDAnews Webinar

    Getting Real About Real World Evidence : Practical Next Steps for Drug and Device Manufacturers

    1:30 p.m. - 2:30 p.m. EDT

    Real world evidence — “RWE,” so-called — is making its way into your world.

    FDA regulation and inspections are being affected in ways large and small. Meanwhile, some bold drug and device makers are finding ways to take business advantage of the opportunities RWE offers, while others hang back, worried about risks and unforeseen consequences.

    In other words, it’s kind of a mess.

    Or, put more kindly, a rapidly developing situation with both regulatory and profit impact that’s certain to affect ... you.

    FDAnews has reached out to Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years, and Dr. Mary Jo Lamberti, a faculty member at Tufts CSDD. They will walk you through the fast-moving RWE changes currently affecting the agency and business decisions alike. In this fast-paced 60-minute webinar, you’ll discover:

    • Ways drugmakers are using RWE to support promotional claims
    • Ways devicemakers are using RWE to support premarket applications
    • Why some manufacturers hesitate to use RWE for promotional claims, fearing charges of unsubstantiated claims, increased legal liability, and increased government surveillance
    • Impact of recent FDA statements: How the agency may want RWE data included in approval and clearance applications, and as a basis for drug and device promotional claims
    • Interpreting FDA guidances: How the agency may use data collected outside of the traditional clinical-trial context to support regulatory decision-making; how RWE “could constitute valid scientific evidence that could be used in some FDA regulatory contexts”
    • The 21st Century Cures Act: How it seeks to speed drug and device approval by shifting certain evidentiary requirements from clinical trials to post-market—in other words, to “the real world.”
    • And much more!

    RWE is real and it’s here to stay. Going forward, you can expect it to move the FDA in new directions, and to affect your business decisions in unanticipated ways. Now is the time to learn what you need to know to stay compliant ... and competitive.

    Who Will Benefit

    Real world evidence (RWE) affects FDA health regulation across the board – devicemakers, drugmakers, biotech, and consultants to these industries that conduct studies or analyses with RWE. This learning session will be of particular interest to:
    • Regulatory specialists
    • Quality specialists
    • Strategic planners
    • Clinical trial developers
    • Data Analysts