April 3-5, 2018


Now celebrating its 15th year, the Medical Device Quality Congress is the premiere opportunity for medical device quality and regulatory professionals to discuss the latest trends with FDA officials and other pros from around the world. As in previous years, MDQC will feature presentations from key FDA officials, and education and advice from the industry’s top experts.

Industry veteran Steven Niedelman of King & Spalding has worked with us to develop a must-attend regulatory quality intelligence conference — one that reflects today’s biggest challenges. We’re one year into the Trump Administration and a lot has changed. Here is some of what you’ll get when you register now for MDQC.

Meet FDA Officials. As in past years, we bring you intelligence right from the regulators. Find out what they have in store, and ask your questions directly!

Pre-Conference Workshop on Complaint Management, avoid the landslide of warning letters about complaint management and get the information you need to make sure your program satisfies FDA inspectors!

Post-Conference Workshop on Post-Market Surveillance: A roll-up-your-sleeves course on implementing risk management and the framework for meeting regulatory obligations at home and abroad.

An Agenda Built Around Your Most Pressing Concerns: The medical device market has experienced significant changes in the last year that affect every aspect of their business. Now is your chance to get the best advice on your most pressing issues. Here are just a few of the many specific issues that you'll hear about when you attend the 15th Annual Medical Device Quality Congress:

  • CDRH’s top strategic priorities for FY 2018
  • ISO 13485 and the countdown to implementation
  • MDSAP audit process update
  • Lean principles in medical device manufacturing
  • European Medical Device Regulations
  • Risk management and cybersecurity for medical devices
  • And much more

It all takes place at the Bethesda North Marriott Hotel, equidistant between FDA headquarters and the attractions of the Nation’s Capital. And not to worry — we’ve scheduled in all the networking opportunities you could wish for over three exciting days.

So mark your calendar and book reservations early. The 15th Annual Medical Device Quality Congress will be happening before you know it. You will be well advised to attend.

To see the full schedule and register, go to:

April 10-11, 2018

Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers
Cambridge, MA

In two action-packed days, you'll learn what FDA investigators use to evaluate your sites. This interactive workshop will teach you how to develop risk-based CQA processes and compliance readiness.

You'll benefit from the first-hand knowledge and experience of workshop leader and expert Michelle Sceppa, a 25-year quality assurance and regulatory compliance veteran in both the pharmaceutical and medical device industries.

Auditing veteran Michelle Sceppa walks you step by step through such details as:
  • A review of how FDA conducts clinical inspections and the top 5 GCP violations
  • How to write GCP audit SOPs — what elements to include
  • Writing a central laboratory audit SOP and why you need this SOP
  • Selecting sites to be audited — creating a master audit plan and how to make sure it is met
  • Audits of a central laboratory — why lab data and testing are a critical component of the clinical study

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!


March 15, 2018

A CenterWatch/FDAnews Webinar

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

1:30 PM - 3:00 PM Eastern

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, to walk you through the fast-moving RWE changes currently affecting the agency and business decisions alike. In this fast-paced 90-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.


March 20, 2018

A WCG/CenterWatch Webinar

Big Data: TMI or Pharmacovigilance Expeditor?

1:30 PM - 2:30 PM Eastern

Big Data. Natural language. Machine learning. Did you know that you can utilize these capabilities to make your pharmacovigilance program more effective and more reliable?

Natural language (the ability to speak into a recording machine and have your words transmitted into a database) and machine learning (which takes all kinds of data from multiple sources) provide actionable information to improve your drug safety program.

You can expedite your pharmacovigilance program by utilizing Big Data techniques to ferret out serious adverse events, determine the causes of those events, make consequential risk management decisions and comply with specific regulatory safety mandates.

This webinar provides you with an overview of how you can use Big Data. You’ll discover how machine learning can plough through vast amounts of material to discard meaningless information while analyzing diverse data on adverse events. It provides you with data —big and small — that directly impacts your pharmacovigilance program.

Here’s what you’ll learn during this interactive session:
  • What Big Data is and isn’t, and how you can utilize it to improve your pharmacovigilance program
  • How the use of natural language can expedite the accurate reporting of adverse events
  • How you can train machines to report whether drugs were a determining factor in an adverse event
  • What the future might bring in terms of new techniques for inputting and analyzing safety data

Take advantage of this free, timely presentation to learn the nuances of big data and new analytical tactics to improve your patient safety program. Sign up now.

Meet Your Presenter

Angela Pitwood is responsible for the ongoing development and management of Vigilare International’s pharmacovigilance operations. With more than 25 years of experience in the pharmaceutical industry, Pitwood is a healthcare professional who offers her clients the assurance that their safety and pharmacovigilance programs are being managed by a seasoned pharmacovigilance executive with experience in developing, implementing and leading global safety operations.

Who Will Benefit

This session is appropriate for biopharma professionals who are responsible for pharmacovigilance programs, including individuals holding these job titles:

  • Biosafety professional
  • Safety manager
  • Risk manager
  • Regulatory specialist


March 20, 2018

A CenterWatch/FDAnews Webinar

Paying Clinical Trial Subjects Deconstructing the Most Important Ethical & Practical Considerations

11:00 AM - 12:30 PM Eastern

If you’re involved in conducting clinical trials in any way, you’re certain about one thing: There is tremendous uncertainty in regard to the appropriate parameters for paying clinical trial subjects. What are appropriate real-world ethical and regulatory considerations that impact payment offers? How are reasonable payment offers to clinical trial participants designed? The research community continues to debate these issues with seemingly no clear-cut answers in sight. You need clarity — not in the distant future — now.

This webinar will systematically review the thorny area of paying subjects in clinical trials — and the particular issues involved in pediatric and geriatric research — to enable you to determine if, when and how to compensate your research subjects. You’ll find out what the regulators think you should be doing — what’s ethical and what’s legal.

In just 90 minutes, from the comfort of your own office, you can take a deep dive into the murky waters of paying subjects in clinical trials and emerge with a fuller understanding of the ethical and practical considerations involved in this critical area of clinical research. Save the date, March 20, 2018, to hear one of the leading authorities on clinical trial subject payment and protection explain the ethical and practical issues.

Here’s what you’ll hear during this interactive session:
  • Reasons to pay research participants, in regard to fairness and the role that payment plays in facilitating recruitment.
  • Ethical and other concerns about offering payment, including the risk of undue influence and the possibility that payment might motivate deception about eligibility.
  • Current practices regarding payment of research participants, such as payment rates and frequency of payment in various types of clinical research.
  • Methods of calculating payment amounts, including distinguishing different reasons for offering payment (such as reimbursement, compensation for time, or recruitment incentive).
  • Understanding the legal, practical and ethical standards for clinical trial subjects.

Meet Your Presenter

Luke Gelinas, PhD., Senior Researcher with Petrie-Flom Center at Harvard Law School is the lead member of a working group dedicated to clarifying regulatory and ethical issues around paying subjects and facilitating investigator proposal and IRB review of payment offers. Gelinas joined the Petrie-Flom Center in 2015 as the first Petrie-Flom Fellow in Research Ethics.

Who Will Benefit

This session is appropriate for professionals who are involved in clinical trials, including individuals holding these job titles:
  • Patient and patient advocacy representative
  • IRB members
  • IRB administrators
  • Clinical project manager
  • Clinical research associate
  • Clinical research team member
  • Biosafety professional
  • Biometrics specialist
  • Data management specialist
  • Medical ethicist

March 27, 2018

A WCG/CenterWatch Webinar

Improving Your Site Feasibility

1:30 PM - 2:30 PM Eastern

In just 60 minutes, from the comfort of your own office, you can get practical insights into determining site feasibility. Don’t spend thousands more dollars on attorneys and consultants. In fact, don’t spend any money at all because this webinar is free. Simply save this date — March 27th, 2018 — to hear one of the leading authorities on site feasibility selection to explain how to:
  • Pre-identify the most likely high-performing sites based on available historical performance data;
  • Provide advice for tightening up feasibility questionnaires to reduce site burdens;
  • Give real-world examples of do’s and don’ts in questionnaire development and how to do it more effectively;
  • Offer insights into response data review and how to handle discrepancies;
  • And much more!

As the industry trends toward doing more with less, your site selection becomes even more imperative. As a sponsor or CRO, you can’t afford to waste time or money on underperforming sites or miss projected timelines in this competitive landscape.

Really, don’t you want to make the site feasibility selection process more predictable, less costly, and far, far more productive?

Take advantage of this free, practical presentation to learn the nuances of site feasibility selection. Sign up today.


April 10, 2018

A CenterWatch/FDAnews Webinar

Risk Evaluation and Mitigation Strategy (REMS)- Staying Ahead of the Regulatory and Enforcement Landscape

1:30 PM - 3:00 PM Eastern

Drugmakers’ latest Washington headache involves REMS. Changes are afoot inside the FDA and the halls of Congress, reaching all the way into the office of FDA Commissioner Gottlieb:

  • The CREATES Act legislation has momentum on Capitol Hill
  • FDA guidances on SSS REMS are on CDER’s 2018 guidance agenda but not yet issued
  • Forthcoming approval of Opioid Analgesic REMS to include immediate-release products

FDAnews has called on a Washington lawyer with a deep FDA regulatory background to show how these fast-moving changes could affect you. Katlin Backfield Esq., former Associate Chief Counsel for Drugs with the Office of Chief Counsel, walks you through:

  • A recap of the basic legal and regulatory framework, plus recent developments in the REMS space
  • Commissioner Gottlieb’s emphasis on drug pricing and how it will affect the development of single shared system REMS
  • Congress: Bills in the pipeline, odds on passage
  • What the FDA has done: A checklist from recent REMS-related enforcement
  • What the FDA could do: Enforcement trends, requiring new REMS, possible changes to the Opioid REMS
  • And much more!

Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.


April 23, 2018

A CenterWatch/FDAnews Webinar

Managing Cybersecurity Risks in the Medical Device and Healthcare Sectors

1:30 PM - 3:00 PM Eastern

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

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

Mark your calendar for Monday, April 23, when Ms. Krayem and Mr. Werner paints the picture over 90 fast-paced minutes. From Cybersecurity Executive Order 13800, to HIPAA, FDA activities, Homeland Security and more, you’ll explore:

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

Do you know what the FDA, HHS, DHS and global regulators are planning? The cost of ignorance could include regulatory sanctions and liability judgments and cybersecurity attacks are only growing. Don’t risk your organization’s well-being in the scary new cyber era.