Events

Conferences

December 4-5, 2018

FDA Data Integrity
For Device And Pharma Firms, And Their Supliers
Arlington, VA

FDA investigators continue to cite a significant number of data integrity observations during inspections… with FDA taking action against companies that commit data fraud — or provide false information.

FDA data integrity requirements are among the most strenuous that regulated industries have to comply with.

And the FDA is keeping pressure on those with data integrity shortcomings — issuing a growing number of warning letters and FDA-483s every year for the last few years. In late 2017 came news that FDA was training its device investigators on how to conduct data integrity inspections.

Investors and business partners are getting into the act, filing multi-million-dollar class-action lawsuits against firms that misrepresented their compliance with FDA requirements. The latest lawsuits against Dr. Reddy’s just add to the list against KV Pharma and other firms.

Your electronic records must be trustworthy and reliable across their entire data lifecycle — from initial data creation all the way through long-term archival.

Compliantly managing your business' essential data can be an overwhelming, even mind-boggling undertaking.

Thankfully, there's an expert with deep knowledge who can explain complex FDA data integrity regulations in simple 'what to do, how to do it' language using real-world examples and offering practical advice.

And that's why you must plan NOW to attend this upcoming interactive workshop presented by FDAnews and Cerulean Associates LLC, a leading consulting firm.

Award-winning FDA compliance expert, author and Cerulean founder John Avellanet will be your workshop leader. He is recognized globally for his business-savvy pragmatic advice and engaging speaking style.

A former FDA and DOJ prosecutor calls Mr. Avellanet, “The best in the business. Period.”

After two days of 'total immersion' study, you'll return to your office with increased understanding based on team exercises and case studies … informative, detailed explanations … and honest no-holds-barred discussions with John and your fellow attendees.

During each of 10 workshop sessions, you'll participate in interactive group projects… review case studies … draft practice business cases, plans and communications … and more.

You'll also simulate investigative scenarios using real data from real inspections — and even determine whether or not warning letters should be issued!

For details and registration, Click Here

December 6-7, 2018

SOPs and Policies for the 21st Century
Arlington, VA

A well-written procedure is written to direct staff and designed to be followed.

Policies and procedures act as a foundation, but one that's flexible like a car's frame and suspension, on which compliance can be achieved confidently and consistently.

And yet — many compliance pros write procedures for the auditor, and not the person who actually has to follow it. Is it more important for the once a year auditor to be happy or for the everyday person to consistently follow the SOP?

While a good SOP helps you demonstrate your compliance and say to inspectors and auditors alike: “We know what we are doing — and why,” the modern SOP enables your business and your compliance success.

In today's busy, stress-filled workplace, your staff needs (and hopes for) SOPs that are easy-to-follow, quick reads. Even regulatory investigators support that idea, saying: “It’s better to have an easy-to-read process map that you can actually follow than to have a detailed SOP that you don’t.”

Yet, in 2017, "inadequate SOPs" was once again a Top 5 most-frequently-cited FDA non-compliance observation.

You can do better. In fact, you must do better.

Take your first big step toward crafting more effective, compliant SOPs.

Attend this highly-interactive, two-day workshop that will teach you down-to-earth, practical techniques you need for writing fast, flexible and compliant SOPs — SOPs that will meet regulatory requirements and today’s globalized expectations.

Plan Now to Attend and Learn from An Award-Winning Compliance Expert

This two-day workshop will be led by John Avellanet, an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style.

Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, John was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance.

Over the past decade, he has been interviewed on public radio programs, in numerous industry magazines and multiple news outlets. He speaks frequently for industry conferences and private corporate workshops.

A former FDA and US DOJ prosecutor has said of John Avellanet, “He is the best in the business. Period.”

What You Will Learn

Not only does this workshop provide you an opportunity to hear from an acknowledged expert in SOPs, but you'll also share experiences and learn from your fellow attendees who are confronting the same issues as you. Attend this critical workshop and you'll find out:

  • How to quickly parse warning letters and Form 483s for SOP expectations
  • What FDA investigator questions to expect about your SOPs and policies
  • How to take advantage of the Policy-SOP-Task Outline hierarchy
  • How to use forms, checklists, and templates to reinforce compliance
  • Where definitions belong in the era of wikis and intranets
  • Why FDA, your staff and your management like to see process maps
  • Simple metrics that work for SOPs and policies
  • How to best use photographs in SOPs
  • What mistakes to avoid in your “SOP of SOPs”
  • How to write an SOP to oversee an activity you’ve outsourced
  • Tips on writing for a line worker
  • Tips on writing for an office worker
  • Tips on writing for scientists and engineers
  • Tips on writing for management

For details and registration, Click Here

December 6, 2018

Emerging Trends In Medical Device Regulation And Quality
Washington, DC

Wearable wellness products. Mobile apps. 3D printing. OTC genetic tests. LDTs. Combination products.

FDA Commissioner Scott Gottlieb has stated that he intends to modernize the FDA’s traditional approach to regulation to ensure that policies are suited to the novel challenges presented by new technology.

What are these initiatives — and how will they affect your regulatory strategy?

It’s time to find out what is OK (and not OK!) to do today … tomorrow … and in the weeks and months to follow.

FDAnews has called on a top medical device regulation experts, Suzan Onel and Will Woodlee, partners at Kleinfeld, Kaplan & Becker LLP, to guide you through the regulatory, quality and legal maze. It’s a day packed full of panel discussions on topics from emerging policies to strategies for working with the FDA. And there’s no need to travel — the whole event is livestreamed for your convenience.

You’ll end the day fully briefed on how to comport yourself in the current regulatory climate … and prepare for what lies down the road. Here’s just a sampling of what the event will cover:

  • Emerging FDA policies — wearable wellness products, 3D printing, OTC genetic tests, lab developed tests (LDTs), and combination products Current trends in enforcement
  • The requirements for disclosure of medical device clinical trial information on ClinicalTrials.gov
  • How the FDA’s regulations on the use of OUS data in premarket submissions have changed
  • How the reorganization of CDRH, ORA, and ODE could affect the development and approval of medical devices
  • Legislative initiatives that may impact medical devices
  • Strategies for interacting with FDA and managing risk
  • Real world, practical insight on making premarket submission decisions and whether to prepare a Letter to File (LTF) or file a 510(k), De Novo, or PMA submission.
  • And much more

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

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

November 27, 2018

A WCG/CenterWatch Free Webinar

Returning Plain-language Summaries to Research Participants

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

Clinical trial subjects deserve to know what they’re getting into. Yet the information at ClincialTrials.gov is far too technical for the average lay person. What can you do to increase subject knowledge and involvement … while decreasing the threat of angry lawsuits?

Make the move to plain-language patient summaries. Discover how.

Mark your calendar for a free webinar from the clinical-trial experts and WCG. Over the course of a fast-paced hour, you’ll discover:

  • Best practices: The state of the art in preparing plain-language summaries
  • Current guidance: Working with Institutional Review Boards (IRBs) that oversee the clinical trials for which patient summaries are provided
  • Case study: How one sponsor works with IRBs during the plain-language-summary creation and delivery process
  • Regulatory issues: Upcoming regulations that may affect how you provide trial results to participants
  • And much more

Your speakers are Jill McNair and David Forster Esq. Ms. McNair is Senior Director for Patient Engagement at The Center for Information and Study on Clinical Research Participation (CISCRP) where she helps trial sponsors turn medicalese into everyday English. Mr. Forster is chief compliance officer of WIRB-Copernicus Group, tasked with enhancing patient protections in clinical trials. Why risk trial-subject anger that can lead to lawsuits, liability and other unpleasantness? Plain-language patient summaries slash that risk while smoothing the trial process. Close the communications gap now with this valuable free webinar.

Who Will Benefit

Study sponsors and IRBs are the targets of this webinar, as well as patient advocacy groups. Plan to participate if you are a:

  • IRB administrator/chair
  • Patient advocacy liaison
  • Clinical operations executive
  • Clinical project manager
  • Medical writer

REGISTER NOW

November 28, 2018

FDAnews/CenterWatch Webinar

REMS: Requirements, Regulation, and Enforcement
Evolution from Safety Program to Enforcement Tool

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

REMS has evolved into a powerful enforcement tool.

Last year there were to significant settlements involving a manufacturer’s failure to comply with REMS strategies.

The Novo Nordisk settlement resulted in disgorgement of $12 million and a payment of $46.5 mill to resolve the False Claims Act liability.

The settlement by Aegerion contained both criminal and civil components. On the criminal side, the company admitted two misdemeanor violations of the FD&C Act, and agreed to pay $7.2 million in criminal fines and forfeiture. The company also entered into a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA. The civil settlement included a $28.8 million payment for False Claims Act violations, a Corporate Integrity Agreement, and a Consent Decree of permanent injunction.

FDAnews has called on Anne K. Walsh, a Washington, D.C., attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. Her presentation alerts you to likely regulatory and legislative changes ahead in coming months, and positions you for better compliance.

You’ll learn about:
  • The recently changed requirements evolving REMS from a safety initiative to a powerful enforcement tool
  • How to protect your company from enforcement actions and strategies for defending an enforcement
  • The most successful strategies to defend against a False Claims Act case based on compliance with safety requirements
  • Recent settlements and what they mean
  • How to prevent a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA
  • Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.
Who Will Benefit
  • Regulatory Affairs
  • Quality Assurance
  • Regulatory Counsel
  • Contractors
  • Consultants

REGISTER NOW

November 29, 2018

FDAnews/CenterWatch Webinar

Chinese Medicine: The Dangers of Deployment
The Impact on Pharmaceutical Regulatory and Quality Specialists

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

Do you have concerns about Chinese API’s and chemical intermediates? If so, you’re not the only one.

More than half of all valsartan products on the U.S. market have been recalled due to a probable cancer-causing chemical in the API. The recall shines a spotlight on growing U.S. and global dependence on China for APIs and chemical intermediates.

Talk of proposed tariffs on Chinese pharmaceuticals has raised concerns about the impact on the supply and price of drugs. Tariffs could be disruptive to the market since China is the sole global supplier of many APIs and chemical intermediates. Supply chain modification is burdensome and can affect quality and access to an unfettered supply.

And China wants to become the world’s pharmacy. What do you need to know? FDAnews has called on Rosemary Gibson — Senior Advisor at the Hastings Center and author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine to discuss the real-world impact of Chinese medicine on public health and the scrutiny it’s undergoing. You’ll learn the following:

  • Three lessons from the valsartan case
  • Three questions to ask API suppliers to ensure GMP
  • How to determine whether or not Chinese medicine is safe
  • How to develop a model and a strategy for determining whether medicines produced by China are safe and effective
  • The rationale for proposed tariffs on Chinese medical products
  • Details of the industry response to tariffs on Chinese-made APIs and chemical intermediates
  • The importance of China’s goal to become the world’s pharmacy and the impact on the global supply chain and regulatory oversight
  • Register today to understand the risks and challenges posed by U.S. dependence on Chinese pharmaceuticals.
Who Will Benefit
  • Regulatory Affairs
  • Quality Assurance
  • Supply Chain Managers

REGISTER NOW

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