March 20-21, 2019

Medical Device Complaint Management
Arlington, VA

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, 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

March 26-27, 2019

Conducting Advanced Root Cause Analysis and CAPA Investigations
Raleigh, NC

Creating an FDA-proof investigation and CAPA isn’t easy.

What if you can’t define a definitive root cause?

What is the relationship between root, contributing and proximal causes to corrections and corrective actions?

What if you could turn to an industry leader who knows exactly what to do?

Well, you can.

Jim Vesper — Director, Valsource Learning Solutions — has more than 25 years of GMP and investigation training experience, and he will provide you with invaluable insights in root cause analysis and CAPA investigations.

Join FDAnews and Jim — March 26-27, 2019 in Raleigh, NC — for an in-depth discussion on how to improve your skills in performing investigations and identifying effective CAPAs by understanding the underlying “whys” and “how-tos”.

In this year’s Conducting Advanced Root Cause Analysis and CAPA Investigations workshop, you will:

  • Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs and investigation reports
  • Describe how accident/incident models can be used when conducting an investigation
  • Differentiate between 6 different accident/incident models
  • Differentiate between root cause, contributing causes and proximal cause
  • Discuss why human error is not a valid root cause
  • Discuss a model that can be used to illustrate multiple layers of control and mitigation
  • Identify 4 different audiences of investigation reports and what each is expecting to see
  • Identify the different sections of an investigation report and what each section should include
  • Given an investigation report with deficiencies, identify ways to improve the report

Space Is Limited — Register Today

But that’s not all. Additional benefits you'll receive when you attend the Conducting Advanced Root Cause Analysis and CAPA Investigations include:

  • Gain valuable strategies for getting information right away in the “golden hours” after the incident.
  • Discover best practices for determining the real cause of human error with tools used by aviation accident investigators.
  • Benchmark current best practices in CAPA and investigations with your peers.
  • Learn practical strategies and techniques you can teach to all your employees.
  • Obtain sample forms for conducting investigations and case reviews.
  • Demonstrate to yourself the value of a cross-functional team and also ways that experts demonstrate their expertise.
  • Understand the four components of a well-written report and Identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors.
Register today and enhance your skills to more effectively identify what caused an unwanted event and ways to prevent future ones.

March 27-28, 2019

ICH GCP E6 R2 Meeting CRO-Vendor Oversight Requirements
Raleigh, NC

What CRO and vendor activities require oversight?

How can you avoid the common pitfalls of effective implementation of CMO-vendor oversight?

How are your fellow CROs handling these and other issues?

Join them and nationally recognized expert Liz Wool, CCRA, CID, CMT for face-to-face discussions on how to handle ICH GCP E6 R2 compliant CRO-vendor oversight.

Liz will provide methods and solutions for effective implementation of the ICH GCP E6 R2 rules. Over the course of the two-day hands-on workshop she’ll:

  • Explain the regulatory authority perspective for CRO and vendors in relation to ICH GCP E6 R2 requirements
  • Identify the CRO-vendors requiring oversight
  • Determine the CRO-vendor practices for oversight of their sub-contractors to meet the requirements and your organization’s expectations
  • Examine effective and compliant CRO-vendor oversight methods
  • Assess CRO-vendor governance-leading practices to implement at your organization
  • Formulate a CRO-vendor oversight plan template for your organization that can be used by multiple departments
  • Examine the common pitfalls to effective implementation and leading practices to mitigate the risks of these pitfalls from occurring in your organization
  • Describe regulatory authority inspection findings regarding CRO-vendor oversight

Through presentations, discussion, class activities and handouts you’ll learn how to implement ICH GCP E6 R2 requirements in your organization. Join us for two days of networking and face-to-face interaction with a nationally recognized CRO-vendor expert.

For details and registration, Click Here

April 8-10, 2019

FDA Compliance Boot Camp 2019
Frederick, MD

Imagine getting inside the head of a working FDA inspector ...
receiving the same training the inspector gets ...
knowing which problems face the most scrutiny ...
all before your next inspection.

Here's how.

Are you confident you'll sail through your next inspection? You can be when you have the same training the FDA gives its own inspectors.

Know what to expect when the next inspector walks through your door -- from what the agency trains its investigators to look for ... to which problems face the most scrutiny, including how FDA expects you to manage your computerized systems and electronic records.

You'll even discover which of your systems will be first-up for inspection. And you'll learn what's behind FDA's new add-on "surveillance inspections" for Part 11 and how the European Union's new Annex 11 affects your operations, no matter where they are.

Former FDA Investigators Ready to Give You "Insider Advice"

Why risk a single noncompliance penalty? When you attend FDA Compliance Boot Camp 2019 you can feel secure in knowing your next inspection will be a complete success ... And it takes less than a week.

Experience a simulated inspection, pick up effective self-auditing techniques and so much more.

Save $695 Now: When You Choose a Multiple Course Track

Choose any one course or a combination of courses to suit your needs and fit your schedule.

Learn more.

April 11, 2019

WCG Global Research Network Roundtable: Nashville
Omni Nashville, Nashville, TN

Please join senior clinical development executives and leading Nashville clinical research sites for a lively discussion of the central question facing the clinical research enterprise: How can we work together to streamline the process of bringing new drugs to patients? We can start answering that question by talking together as a community to understand the problems — and find practical solutions to them.


7:00 AM - Registration, Breakfast and Networking

7:30 AM - Opening Remarks
Sean Walsh, President, Independent Sites, WIRB-Copernicus Group

7:45 AM - Round Table Discussion: Let’s All Get on the Same Team
Featuring: Sean Walsh, President, Independent Sites, WIRB-Copernicus Group (moderator)

8:45 AM - Closing Remarks
Sean Walsh, President, Independent Sites, WIRB-Copernicus Group

9:00 AM - Conclude

Space is limited, so register today at no charge. Maximum two attendees per site. LEARN MORE

The WCG Global Research Network leverages the unparalleled scope of WIRB-Copernicus Group’s relationships with biopharma and medical device companies. Join the WCG Global Research Network so we can help you get the studies everyone wants.

GRN membership is free. Members receive a complimentary subscription to the WCG SiteView Report, with actionable insights so sites can best position themselves in the competitive landscape, and CenterWatch’s Research Practitioner, with timely and informative articles and practical clinical research management tools.

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 opens January 1, 2019! Early Bird Deadline is March 10. Complete registration information can be found at

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

For more information, please visit or contact

April 23-25, 2019

16th Annual Medical Device Quality Congress
Bethesda, MD

Save the date!

Testimonials From Past Attendees:

“I love coming away having learned something new that I didn’t realize I was missing.”

“I liked the breadth of information presented and the knowledge of the speaker. I also liked the informal atmosphere that allows for questions during the day and not just during specific.”

“Great information and excellent speakers.”

Click here to get updates and the complete agenda as soon as it’s available.

May 7-8, 2019

Building A World-Class Advertising And Promotion Review Program
Boston, MA

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 Boston in May 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?

    Need resources to stay on top of future developments? The workshop binder materials alone are worth the tuition cost. Checklists for promotion pre-approval and effective review, FDA documents, complete and unabridged ... relevant sections of Form 2253 [CFR] ... PhRMA's Principles on DTC Advertising and Principles on Interactions with Healthcare Professionals ... ... and much more!

    Your workshop leader is Dale Cooke, principal of Philly Cooke Consulting. Mr. Cooke's practice specializes in helping FDA-regulated companies develop compliant promotional tactics and improve the promotional review. He is the author of Effective Review & Approval of Digital Promotional Tactics and is currently at work on a book about compliant social media usage for prescription product manufacturers.

    And here's a bright idea: Pass this on to your ad agency or marketing consultant. Better yet, bring them along for a crash course in the stuff they need to know too!

    Whatever your line of endeavor — drugs, biologics, devices — if you advertise, the FDA has its eye on you. Why risk a Form 483 or a warning letter when compliance help is so close at hand?

    For details and registration, Click Here

  • May 16, 2019

    Post-Market Surveillance
    Washington, DC

    FDA’s Sentinel System… the iMEDS Program… Rapid technological change…

    Post-market surveillance can be mind-boggling. The FDA is requiring drug and device manufacturers to make more accurate assessments of how a product is marketed, sold and used in practice to determine more precisely the degree of efficacy and any resulting adverse events.

    Here’s how to master the new rules — quickly, confidently, authoritatively.

    Mark your calendar for Thursday, May 16, when FDAnews and Alston & Bird LLP conduct a full day of interactive learning featuring top FDA lawyers from Alston & Bird, plus a key FDA regulator. Make ready to discover:

    • Successful strategies for drug pharmacovigilance under CDER
    • Understanding device post-market surveillance under CDRH & §522
    • Public-private partnerships: How the Sentinel and iMEDS programs can help in your PMS
    • 21st Century Cures & PDUFA VI: New FDA initiatives and opportunities
    • Real world evidence: How to leverage it to your best advantage
    • Horror stories and hypotheticals: Post-market surveillance nightmares to avoid
    • And much more!

    Your faculty includes an all-star legal cast from the FDA regulatory team at Alston & Bird under the guidance of partner Cathy Burgess Esq., moderator. Her presentation team comprises partner Marc Scheineson Esq., senior associate Brendan Carroll Esq., and associates Seth Olson Esq. and Justin Mann Esq.

    A highlight of the day is the luncheon presentation featuring an FDA regulator. Invitations are pending to top agency officials with post-market regulatory authority.

    The workshop takes place in Alston & Bird’s Washington offices, located in the heart of the nation’s capital. You’re surrounded by fine dining, shopping and world-class museums. Accommodations are on your own, so here’s a suggestion: Tack on a day or a long weekend and enjoy the nation’s capital in glorious spring, our finest season.

    Ensuring your products are safe and effective once they reach the market is all-important — to safeguard patient well-being, avoid lawsuits and liability, stay clear of warning letters and Forms 483. Make sure you do it right.

    For details and registration, Click Here

    June 10-12, 2019

    Post-Market Surveillance
    Waltham, MA

    If you sell medical devices in the global market, changes are looming that will affect your operations greatly.

    They’re summed up in the initials EU-MDR, short for European Union Medical Device Regulation, a new set of rules that virtually throws out the existing EU-MDD (Medical Device Directive).

    In 175 pages of eye straining text, you’ll encounter unfamiliar rules and terms… expanded General Safety and Performance Requirements… increased requirements for risk management and post-market surveillance… and much more. We are here to assist you!

    You have until May 2020 to comply. Act fast.

    Mark your calendar for two, or three, productive days of hands-on training with Dan O’Leary of Ombu Enterprises, one of FDAnews’ most in-demand trainers. Over the course of two days (June 10-11), you will understand and implement the new MDR:

    • The new MDR classification system (how to apply the system)
    • Conformity assessment paths (how paths apply to specific devices)
    • Annex I requirements (how to document compliance)
    • Technical documentation requirements
    • Unique Device Identification (EU approach)
    • Notified Body (its role)
    • And much more!

    For details and registration, Click Here

    October 23-25, 2019

    14th Annual FDA Inspections Summit
    Bethesda, MD

    Save the date!

    Testimonials From Past Attendees:

    “Great discussion and knowledgeable panel. I enjoyed having the FDA give examples in their own words…”

    “The panels were great. Very informative and great discussions.”

    “Great and interesting sessions. Great panel discussions and attendee participation.”

    “I certify this Summit a success.”

    Click here to get updates and the complete agenda as soon as it’s available.

    Training Programs

    There are more training programs to come. Please check back soon.

    If you would like to post a training program yourself, please contact us at or call (866) 219-3440 to speak with a representative.


    March 18, 2019

    FDAnews/CenterWatch Webinar

    OTC Regulation: Latest Developments and Best Practices

    1:30 p.m. – 3:00 p.m. EDT

    There’s pending OTC monograph legislation in Congress that could result in significant changes in the OTC space. And, the FDA issued draft guidance on OTC innovation in 2018.

    Christine Kirk — an associate in the Food and Drug Group of Arnall Golden Gregory’s healthcare practice — will discuss recent developments in OTC regulation and enforcement as well as key compliance topics. You’ll learn about:

    • Significant OTC monograph reform legislation that is currently pending in Congress (H.R. 269) which would:
      • Establish an OTC user fee program
      • Change the way that monographs are issued
      • Provide a pathway for limited exclusivity for certain OTC products
    • 2018 draft guidance on innovation in the OTC space published as Innovative Approaches for Nonprescription Drug Products which includes:
      • The development of labeling in addition to the DFL
      • The implementation of additional conditions so that consumers appropriately self-select and use the product
      • Recent OTC-related enforcement actions
      • Common areas of confusion — such as marketing claims and labeling requirements
      • compliance issues and resources

    You’ll come away with a deeper understanding of the recent developments in the OTC area.

    Who Will Benefit?

    • Regulatory
    • Legal
    • Compliance
    • Advertising and promotion


    March 19, 2019

    FDAnews/CenterWatch Webinar

    Medical Imaging: Latest Regulatory, Compliance and Quality Developments

    1:30 p.m. – 3:00 p.m. EDT

    "AI based diagnostic imaging approaches provide an opportunity to improve patient prognosis, identify digital biomarkers of early response to treatment, or develop novel clinic-genomic phenotypes that could be used to triage patients for routine scans based on their likelihood of eventually developing an aggressive cancer. Toward these goals, the FDA is exploring the use of a neutral third party to collect large annotated imaging data sets, for example highly annotated radiology scans used in a variety of clinical trials for specific disease indications.”

    Lauren Silvis, FDA Chief of Staff

    As electronic technology advances, its integration into medical devices — specifically medical imaging devices — challenges the FDA to regulate the integrated devices and still allow new technologies to the market in a reasonable time.

    J. Lawrence Stevens, RAC — an expert witness for cases involving FDA compliance for medical devices — will discuss the latest FDA trends and how to keep your company competitive. After attending this webinar, you’ll understand:

    • The nuances of the latest in FDA premarket and post market requirements for medical imaging devices including:
      • Ultrasound Imaging
      • MRI (Magnetic Resonance Imaging)
      • Pediatric X-ray Imaging
      • Medical X-ray Imaging
      • Radiography
      • Computed Tomography (CT)
      • Dental Cone-beam Computed Tomography
      • Fluoroscopy
      • Mammography
    • How to comply with Title 21 – Food and Drugs, Chapter 9, FA&C Act, Subchapter V, Drugs and Devices
    • How to comply and interpret FDA’s Guidance on Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff Issued Date 10/02/17
    • What the recent article, “The Long Run Is Now: How FDA is Advancing Digital Tools for Medical Product ,” by Lauren Silvis, FDA Chief of Staff means for medical imaging regulation

    This is your chance to hear from an expert on FDA medical device regulation on how the FDA is using its authority in the new generation of medical imaging devices

    Who Will Benefit?

    • CEO’s
    • VP RA/QA
    • VP R&D
    • Directors of RA
    • Directors of R&D


    March 20, 2019

    FDAnews/CenterWatch Webinar

    Best Practices for Facilitating Pediatric Clinical Trials: How to Recruit and Retain Patients

    1:30 p.m. – 3:00 p.m. EDT

    Pediatric clinical trials present their own unique challenges. Children are not simply mini-adults.

    You need to understand the intricacies of pediatric clinical trials — how to finesse your pediatric clinical research skills.

    Lisa Benson, BS, CCRP, CRCP and Janelle Allen, BS, MS, CCRP — both of the Institute of Advanced Clinical Trials for Children — will discuss how to be successful when dealing with the differences and challenges faced while conducting pediatric clinical trials. Over the course of 90 minutes they’ll help you understand how to:

    • Develop study budgets specific to pediatric clinical trials, including recruitment and administrative costs attendant to pediatric trials
    • Identify the challenges faced when conducting pediatric clinical trials, such as:
      • Pediatric tactics of assent and consent
      • Low recruitment to trials
      • Rare diseases barriers
    • Regulatory and ethical issues in pediatric clinical trials, including FDA guidance and best practices for dealing with children and their parents
    • Strategies for successful retention of children in clinical trials
    • Approaches to recruitment in pediatric research, including the pros and cons of using different forms of standard and social media
    • Overcoming some of the challenges of long term follow-up in pediatric clinical trials, including record-keeping obstacles
    Learn how to improve your skills and understand your roles and responsibilities when conducting research in the pediatric population

    Who Will Benefit?

    • Clinical Research Coordinators
    • Research Nurses
    • Research Administrators
    • Principal Investigators
    • Clinical Trial Managers
    • Clinical Trial Directors
    • IRB Staff
    • Data Managers
    • Clinical Trial Monitors
    • Financial Analysts
    • Budget Analysts


    March 21, 2019

    A WCG Webinar

    The Patient Perspective: A Conversation with Mary Elizabeth Williams

    3:00 p.m. EDT

    In August 2011, Mary Elizabeth Williams was told that her melanoma had returned... and metastasized. In October, she started dosing in a phase 1 immunotherapy clinical trial. And in January 2012, she was told that she had a complete response... and has remained free of detectable cancer ever since.

    In her moving book, "A Series of Catastrophes and Miracles," Ms. Williams talks about her cancer journey, her experience of being a clinical trial participant, and about her friends with cancer whose stories didn’t end as happily.

    In this webinar, we’ll talk to Ms. Williams about the patient perspective in clinical trials; the view from inside a trial, and what the clinical research community is - and isn’t - doing well in recognizing patients as partners in the development of new therapies.


    Mary Elizabeth Williams
    Clinical Trial Participant and Author of
    "A Series of Catastrophes & Miracles"

    Lindsay McNair, MD, MPH, MSBioethics
    Chief Medical Officer, WCG


    March 21, 2019

    FDAnews/CenterWatch Webinar

    FDA’s 2019 Medical Device Regulation Agenda

    1:30 p.m. – 3:00 p.m. EDT

    The CDRH issued two lists of planned final and draft guidances for 2019 — an A-list of guidances it intends to publish and a B-list of guidance it will publish “as resources permit.”

    A-list final guidance topics that CDRH plans to issue include unique device identification and compliance dates for Class I and unclassified devices. The A-list draft guidance topics that CDRH plans to publish include premarket submissions for cybersecurity; labeling recommendations for surgical staplers and staples; nonbinding feedback after FDA inspections; lifecycle regulatory requirements for medical device servicing; computer software assurance; content of premarket submissions for software contained in medical devices; and accreditation schemes for device conformity assessments.

    Topics for the B-list include: testing considerations for implanted brain-computer interface devices for patients with paralysis or amputations; UDI for convenience kits; and medical x-ray imaging devices conformance with IEC standards.

    Jessica Ringel — Counsel, King & Spalding, Washington, D.C. — will discuss how CDRH will prioritize digital health, advance device safety and security, offer more flexibility and options for premarket submissions, sustain high-quality servicing, provide efficient oversight, handle uncertainty in devices and engage patients. You’ll learn about:

    Recent revisions to the medical device guidance and activities required by the FDA Reauthorization Act (FDARA) Nuances pertaining to quality and regulatory professionals included in CDRH’s FY 2019 guidance agenda — with a recap of recently issued guidance and identification of what is ahead Status of the ever evolving, voluntary FDA pilot programs, including expectations for FDA’s Digital Health Software Pre-Certification Program as it enters the 2019 test stage Current status of FDA’s Case for Quality Voluntary Improvement Program Understanding the FDA guidance… programs… and policies that may be on the horizon, as well as those that have been recently announced, will help you prepare for changes in regulatory policy, and utilize advantageous programs.

    Who Will Benefit?

    • Quality and regulatory professionals
    • Operational and management
    • Executive and strategic
    • Legal and compliance


    March 22, 2019

    FDAnews/CenterWatch Webinar

    REMS Regulatory Developments and Best Practices

    1:30 p.m. – 3:00 p.m. EDT

    Is your REMS program compliant with new FDA expectations?

    Lynn Mehler — partner in the Hogan Lovells pharmaceutical and biotechnology practice — will address the FDA’s current expectations in designing a program to assess REMS, and how to make your program compliant with those expectations. You’ll learn about:

    • How REMS assessments have changed over the more than 10 years since REMS was enacted
    • The FDA’s current expectations in designing a program to assess REMS and how to make your program compliant
    • The REMS assessment process, including what goes on behind the scenes
    • How REMS assessments can lead to additional requirements, separate and apart from modifications to a REMS
    • How to use REMS assessments to build a case for REMS modification including elimination of requirements
    • How to comply with two significant recent guidances, Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement

    You’ll come away with a deeper understanding of the FDA’s current approach to REMS, including the increased focus on and complexity of the REMS assessment process.

    Who Will Benefit?

    • Regulatory and quality professionals
    • Executive suite
    • Regulatory affairs/compliance
    • Medical affairs/pharmacovigilance
    • Product lifecycle managers
    • Labeling specialists
    • Risk managers
    • General/corporate counsel
    • Outside attorneys


    March 25, 2019

    FDAnews/CenterWatch Webinar

    How to Make Your Clinical Trials Truly Patient-Centric: Best Practices for Optimizing Patient Engagement and Input

    1:30 p.m. – 3:00 p.m. EDT

    It’s essential that the clinical trial industry is prepared to meaningfully engage and include the patient voice and experience.

    Being patient-centric is not merely a buzzword. It’s how clinical trial professionals can improve their clinical trials by involving patients in recruitment efforts, consent agreements, educational materials and treatment and engagement during clinical trials.

    Maggie Buckley, Volunteer Patient Advocate — Pamela Bennett, RN, BSN, CCE, Executive Healthcare and Corporate Affairs Consultant and — Danya Kaye, Director of Business Development, R&D and Innovation at Inspire — will discuss how clinical trial professionals can improve their clinical trials by involving patients in recruitment efforts, consent agreements, educational materials and engagement during clinical trials.

    Over the course of 90 minutes they’ll help you learn:

    • Three considerations that you should keep top of mind prior to beginning a patient engagement program — including the initial outreach to the patient community
    • Three recommendations critical to engaging directly with patients as advisors — including during the recruitment process
    • Three approaches to developing a patient advisory board to help guide your clinical development program — including the types of patients who should be on that board
    • Three elements necessary to engage patients and patient advocacy organizations in clinical trial development and treatment — including communication strategies
    • Three ways to engage patients to inspire, motivate and educate your colleagues about the value of their work
    • Hear different perspectives about innovative approaches to patient centricity and engagement directly from a patient advocate leader, a clinically experienced healthcare professional executive, and a director of the leading social network for health connecting patients and caregivers.

      Who Will Benefit?

      • Medical Affairs
      • Patient Relations
      • Clinical Development
      • Patient Advocacy
      • Corporate Compliance
      • Internal Communications
      • Business Development


    March 26, 2019

    FDAnews/CenterWatch Webinar

    Data Integrity in Clinical Trials

    1:30 p.m. – 3:00 p.m. EDT

    In 2017, 60% of the warning letters issued by the FDA were the result of a lack of data integrity. This clearly shows how important data integrity is to your clinical trial.

    Donna Kessler, PhD., Research Integrity Officer at Duke University, will discuss the increased focus — nationally and globally — on the reliability of research data, honesty in reporting, and data reproducibility in an era of heightened competition and pressure. Over the course of 90-minutes she’ll help you understand:

    • How regulatory authorities are defining research misconduct, and how to avoid legal hot water by complying with clinical research integrity guidelines in consent forms and marketing disclosures
    • What are questionable research practices (QRPs), especially in dealing with vulnerable populations
    • How to avoid wrongdoing in your clinical research by complying with current regulatory guidelines for proper conduct
    • How costly wrongdoings are in clinical research on both the personal and professional level
    • Tips for compliance in conducting proper research in the areas of subject recruitment, consent, record-keeping, and patient outreach and communication
    After attending this webinar you’ll recognized the importance and the threats to integrity in clinical research

    Who Will Benefit?

    • Clinical Trial Electronic Systems Developers
    • Clinical Trial Statisticians and Statistical Programmers
    • Clinical Investigators and Clinical Investigator Site Staff
    • Regulators- GCP Inspectors
    • Regulators- Reviewers/Assessors of Clinical Trial Data


    March 28, 2019

    FDAnews/CenterWatch Webinar

    Cell & Gene Therapy Strategies for Successful BLA Submissions
    Best Practices for Phase I to FDA Approval

    1:30 p.m. – 3:00 p.m. EDT

    “The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications. Based on this activity, we anticipate that the number of product approvals for cell and gene therapies will grow in the coming years, reflecting significant scientific advancement and the clinical promise of these new innovations.”Scott Gottlieb, FDA Commissioner, January 15, 2019 announcement

    Gottlieb goes on to say that he predicts the FDA “will be approving 10-20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.”

    Sponsors need to prepare. The FDA is already getting ready by staffing up the review group for cell and gene therapy products and planning new guidance documents and policies to help sponsors.

    Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy — will discuss the FDA’s requirements for successful BLAs and how to comply and make you aware of the common mistakes and how to avoid them. He’ll help you understand:

    • What the FDA requires for a successful cell therapy or gene therapy BLA
    • What reviewers in the Office of Tissues and Advanced Therapies expect to see
    • How a cell or gene therapy BLA fits into the framework of the CTD
    • How the earlier stages in development affect the content of the BLA
    • What the January 2019 announcement by FDA Commissioner Gottlieb about the surge of cell and gene therapy products entering early development means for you

    It’s time to get prepared for the unique challenges of BLAs for cell and gene therapy products.

    Who Will Benefit?

    • Regulatory affairs
    • Quality affairs
    • Manufacturing, manufacturing process development, analytics R&D
    • Senior management at smaller cell and gene therapy biotech companies


    March 29, 2019

    FDAnews/CenterWatch Webinar

    The Common Rule: Changes to Come

    1:30 p.m. – 3:00 p.m. EDT

    Kristin J. Craun, MPH, CIP, Senior Director of the Institutional Review Board at the University of Southern California, will help clarify key aspects of the revised Common Rule and discuss approaches for educating your research teams and ensuring compliance. Over the course of 90 minutes she’ll help you understand how:

    • The new exempt categories may reduce your obligations in human subject protection
    • The new required elements of consent change the standards for informing patients and obtaining consent — increasing your subject protection responsibilities
    • The use of continuing review policies apply to minimal risk research, and its effect on your daily responsibilities in managing clinical trials
    • How one academic medical center is implementing the new Common Rule standards and developing best practices in several keys areas — including subject protection policy and practice and modifications to its electronic submission system
    • The new Common Rule requirement allows flexibility in some clinical trial areas — and the key factors in determining when and how this flexibility can be utilized

    After attending this webinar you’ll know how the revisions of the Common Rule parallel flexibility efforts for unregulated research and identify the key challenges when implementing different sets of regulations.

    Who Will Benefit?

    • Clinical Quality Assurance Professionals
    • Clinical Operations Professionals
    • Data Management Professionals
    • Clinical Trial Electronic Systems Developers
    • Clinical Trial Statisticians and Statistical Programmers
    • Clinical Investigators and Clinical Investigator Site Staff
    • Regulators- GCP inspectors
    • Regulators- Reviewers/Assessors of Clinical Trial Data


    April 1, 2019

    MAGI/CenterWatch Free Webinar

    The Basics of GDPR for Researchers

    1:30 p.m. – 2:30 p.m. EDT

    How does the European Union’s new privacy regulation impact your data? When does General Data Protection Regulation (GDPR) apply to your research study? What are your obligations?

    Mark your calendar for a FREE webinar from three legal experts who will provide an overview of the key terminology used in the GDPR, the territorial scope of the regulation and the obligations it places on different parties in the research enterprise. Over the course of a fast-paced hour, you’ll:

    • Understand the territorial scope of the GDPR
    • Gain fluency with the key terminology used by GDPR, including terms like personal data, pseudonymization and anonymization
    • Familiarize with the bases for processing personal data in clinical research
    • Learn the key compliance obligations that the GDPR places on researchers — particularly those in the U.S.

    Feel free to share this webinar invitation with others

    Who Will Benefit?

    All members of the EU-MDR transition project should attend, to include:

    • Attorneys
    • Privacy officers
    • Study coordinators
    • Principal investigators


    April 2, 2019

    FDAnews/CenterWatch Webinar

    Pharmaceutical Data Integrity 5 Steps to Build a Quality Culture

    1:30 p.m. – 3:00 p.m. EDT

    "FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks.”

    FDA, Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry

    Quality needs to be a top priority for leadership — including building a culture where employees are invested in maintaining quality.

    Cynthia Schnedar, Executive Vice President and Liz Oestreich, Vice President — both of Regulatory Compliance at Greenleaf Health, Inc. — will offer recommendations on how to build and maintain a culture that values quality and supports data integrity in the manufacturing process. Over the course of 90 minutes you learn:

    • Best practices in building a culture of quality — including compliance with WHO and FDA data integrity standards
    • Why quality must be a top priority for leadership when it comes to maintaining an unadulterated drug supply
    • The nuances in Commissioner Gottlieb’s statement on achieving drug manufacturing quality
    • Tips on how to ensure employees are invested in maintaining quality and how to avoid passive non-involvement
    • How to tie to the importance of quality into a company’s core values
    • The ALCOA principle, which requires that records are attributable, legible, contemporaneous, original, and accurate

    You’ll gain practical tips for how to build a quality system and gain insight on WHO and FDA guidance on data integrity.

    Who Will Benefit?

    • Clinical Quality Assurance Professionals
    • Clinical Operations Professionals
    • Data Management Professionals
    • Clinical Trial Electronic Systems Developers
    • Clinical Trial Statisticians and Statistical Programmers
    • Clinical Investigators and Clinical Investigator Site Staff
    • Regulators- GCP inspectors
    • Regulators- Reviewers/Assessors of Clinical Trial Data


    April 4, 2019

    FDAnews/CenterWatch Webinar

    EU-MDR Soft Transition

    1:30 p.m. – 3:00 p.m. EDT

    If you plan to continue putting devices on the European market, you’ll need to implement the EU-MDR.

    Due to the slow progress in the EU resources — guidance documents, harmonized standards and notified bodies — companies are being sent to the soft transition.

    Dan O’Leary, one of FDAnews’s most popular presenters, will explain the hybrid system where you maintain a device certificate under the MDD and a QMS under the MDR. After 90 minutes you’ll understand:

    • the dates from the EU-MDR for when the hybrid system can apply
    • the requirements for working with the MDD Notified Body
    • the requirements from the MDD that apply to the device
    • the three elements from the MDR Chapter VII – post-market surveillance, market surveillance, and vigilance
    • the role of economic operators and their registration requirements
    • the role of device registration and the required data elements
    • how to structure the technical documentation for the hybrid system

    BONUS: You’ll receive a set of checklists to help implement the hybrid system required during the soft transition period.

    Start implementing the hybrid MDD/MDR system to keep your products on the European market until the full EU-MDR comes into effect.

    Who Will Benefit?

    All members of the EU-MDR transition project should attend, to include:

    • Quality Directors
    • Quality Managers
    • Regulatory Affairs Directors
    • Regulatory Affairs Managers
    • Design Engineering Managers
    • Product Marketing
    • Post-production Specialists
    • Vigilance Specialists


    April 9, 2019

    FDAnews/CenterWatch Webinar

    Using KPIs to Improve Site Performance

    1:30 p.m. – 3:00 p.m. EDT

    Transform your raw and unstructured data into meaningful information. Make smarter decisions based on intelligence derived from the clinical trial data.

    Kelly Smith, CCRP, Sr. Solutions Consultant for Bio-Optronics, will discuss how pharma and biotech companies can best take advantage of KPIs. She’ll provide tools and tips to better centralize and streamline your processes. Over the course of 90 minutes she’ll help you understand how to:

    • Improve your business development chances by illustrating turnaround times and other KPI metrics when communicating and selling services to potential clients
    • Develop better feasibility by quickly and easily finding turnaround times, win rates, loss/not selected rates and potential revenue per patient
    • Accelerate your start up activity by using KPIs to set goals and measure progress/performance against those goals, such as CTA turnaround time or total start up time (selection to FPFV)
    • Improve recruitment and enrollment by measuring campaign performance to easily finding cost per screened patient
    • Improve operations by quickly and easily measuring CRC utilization and capacity, no show rates, and screen fail rates
    • Utilize more productive tools to better centralize and streamline your processes
    • Choose improved protocols to set attainable enrollment goals and track financials, resulting in increased efficiencies and revenue overall

    This presentation will illustrate how technology can assist in streamlining your operations and improve your business decisions.

    Who Will Benefit?

    • Clinical Research Associates
    • Investigators
    • Clinical Project Managers
    • Regulatory Affairs Personnel
    • Medical Writers