March 6-8, 2018



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

To see the full schedule and register, go to:

February 7-8, 2018

Investigator Initiated Sponsored Research (IISR) 2018
Boston, MA

CBI’s IISR 2018 — Investigator Initiated Sponsored Research is the only annual event dedicated exclusively to helping you and your organization improve your IISR Programs by providing innovative and forward-thinking approaches to support collaborative partnerships, promote proactive contracting, financial planning and integrate best practices in clinical operations for medical affairs excellence in the global expansion of clinical trials. Now in its 6th year, CBI’s IISR Summit charges forth into 2018 with new collaborative workshops, partner-driven panel discussions and SOP information deep-dive session for all your need-to-know best practices and technical solutions for managing your rapidly evolving IIT portfolio.

For details and registration, .

February 13-18th, 2018

SCOPE Summit for Clinical Ops Executives 2018
Orlando, FL

The 9th Annual SCOPE Summit, taking place February 13-15, 2018 in Orlando, FL, will offer three stimulating days of in-depth discussions in 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Resource Management and Capacity Planning, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Supply Chain, and Precision Medicine.

For details and registration, .

April 4-5, 2018

Let’s improve clinical trials today!
Gaylord National Resort and Conference Center, Maryland

Join industry leaders from pharma, biotech, clinical research organizations, health care organizations, and advocacy groups to advance patient and physician participation in clinical trials. The forum will discuss how we can bridge people and processes, technology and regulations. Become a sponsor!


Training Programs

More to come soon


January 9, 2018


Uniting Digital Technology with Your Quality Data

1:30 PM - 2:30 PM Eastern

The world has gone digital. Is your organization keeping up? If the answer is ‘no’ ... or even ‘yes, but’ ... why not spend an hour with someone who can help? Especially when it’s FREE.

Meet Chris Thornton, Director of Global Accounts at Sparta Systems, a leader in helping drug and device makers meet the challenges that stem from FDA scrutiny, mergers and acquisitions, patent expirations, cost cuts and supply-chain woes.

On the afternoon of Tuesday, Jan. 9, Mr. Thornton spends an hour showing you cutting-edge ways to use digital technology for streamlining quality processes, consolidating systems, achieving full compliance and taming unruly risk. You’ll discover:
  • The impact Industry 4.0 and Internet of Things (IoT) has in your quality ecosystem
  • The GXP-regulated environment: Benefits — and challenges — of cloud platforms and other digital innovations
  • Augment your quality strategy with cloud technology
  • And much more!

Digital transformation is here now. New manufacturing and business processes are being fueled by automation, communication and computing technologies. Spend an hour learning from Chris Thornton and Sparta Systems. The cost is free ... but the benefits are invaluable. Sign up now.

January 17, 2018


How to Get IVD Approval Through CFDA - Key Premarket Submission Tips

1:30 PM - 3:30 PM Eastern

Marketing into Asia just got more complicated for device and IVD makers. The China FDA (CFDA) has changed the rules significantly on IVDs, and further changes are expected. Plus, lest you forget, most IVDs require clinical trials in China. (They’re clinically exempt in the U.S. and the E.U.)

FDAnews has invited China FDA expert Grace Fu Palma to bring you up to speed. Her 90-minute presentation is a must for the medical device and IVD community wanting a piece of China’s booming IVD market (20% growth year after year!). Prepare to dig deep into these key topics:
  • CFDA IVD registration requirements and how they differ from FDA classifications
  • How to prepare samples to pass local IVD approval tests
  • Differences in motivation and criteria between U.S. and China IVD regulatory schemes
  • Changes in the clinical trial exemption catalog
  • Changes in CFDA #650 medical device supervision and monitoring in regard to registration of legal agents
  • And much more!
That’s a lot of ground to cover in just 90 minutes. China’s regulators have been busy:
  • Clinical trial exempt list catalog was released on Oct. 30, 2017
  • Clinical trial exempt IVD CER requirements if not clinical trial were promulgated Nov. 8, 2017
  • Medical device supervision and monitoring (#650) registration legal agent status is expected to be changed soon
  • Success in the booming China IVD market requires a thorough understanding of how that nation regulates IVDs and how those regulations are changing. This webinar can help protect your competitive edge.

January 18, 2018


Medical Device Calibration Program- A Step-by-Step Guide

1:30 PM - 3:30 PM Eastern

Devicemakers: The quality of your manufacturing is only as good as the quality of your measuring equipment. But you can spend a fortune on metering devices and still turn out shoddy products. It all depends on how well they’re calibrated.

Mark your calendar for a roll-up-your-sleeves learning session led by the guru of quality in device manufacturing, Dan O’Leary of Ombu Enterprises. You’ll pay close attention as he walks you through the intricacies of FDA’s requirements:
  • The role of monitoring and measuring in a medical device Quality Management System (QMS)
  • The requirements in FDA’s QSR for calibration
  • The requirements of ISO 13485:2003 and ISO 13485:2016
  • The distinction between “accuracy” and “precision”
  • The role of traceability in a calibration program
  • The audit tasks in both QSIT and MDSAP
  • And much more!

Drawing on actual warning letters, data from FDA’s Quality System Inspection Technique (QSIT) and the Medical Device Single Audit Program (MDSAP) Audit Model, Mr. O’Leary spells out FDA requirements for control of inspection, measuring and test equipment; IM&TE in the Quality System Regulation (QSR); ISO 13485:2003, and ISO 13485:2016.

Special Bonus Material: Participants receive a checklist with the requirements from FDA QSR, ISO 13485:2003, and ISO 13485:2016.

Device defects lead to warning letters, lawsuits, liability ... and, in the worst case, patient deaths. Why take such a risk when it’s so easy to get up to speed on this important area of manufacturing quality? Make the decision: Sign up now.

January 24, 2018


Medical Product Advertising & Promotion- Social Media Do's and Don'ts

1:30 PM - 3:30 PM Eastern

Social media is a two-edged sword — a boon for getting your message out, a magnet for warning letters should you run afoul of the FDA.

And other agencies are watching your social media behavior too — the FTC and the CPSC, to name two. Time to consult a lawyer? Or simply ...

Mark your calendar for a get-together with two of Washington’s top lawyers specializing in the intersection of social media and federal regulation. It’s an FDAnews webinar where you’ll discover:
  • Common social media mistakes that trigger warning letters
  • How to deal with misleading, untruthful and/or biased posts
  • FDA enforcement activities to date
  • Use of social media for adverse event reporting and product improvement
  • FDA moves that could affect your use of social media
  • And much more!

Your presenters, Naomi J.L. Halpern Esq. and Georgia C. Ravitz Esq., are experts at the Washington headquarters of Arent Fox LLP. Spend 90 minutes picking their brains — without paying one cent extra in billable hours.

FDA guidances set the social media rules, but also offer useful help — managing your social media presence, for public disclosures for sharing marketing and off-label information, and dealing with damaging information posted on social media.

Social media will only grow more central to your marketing and communications. But it’s a legal minefield too, best navigated with the help of expert lawyers. That’s reason enough to take part in this timely presentation. Sign up now.

January 26, 2018


Lean Management to Improve Quality & Compliance - Deliver Product Quicker, Safer, and Cheaper?

1:30 PM - 3:30 PM Eastern

“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up.

Mark your calendar for Friday, Jan. 26, when management guru Miguel Guerrero introduces you to:
  • “Input Control Templates,” a means to reduce or end rework on processes
  • The “Poke Yoke,” a way of slashing errors in development processes
  • How Lean Principles save money, boost productivity, and enhance quality in drug and device manufacturing
  • And much more!

You’ll discover systematic methods of excellence-seeking — identifying value, mapping the value stream, creating flow, establishing pull — and learn ways to work out which activities are worth doing, create systems that facilitate such goals, and develop methods to perform the activities themselves more efficiently and profitably.

For Baxter Diagnostics, Mr. Guerrero introduced dozens of profit-building innovations including the first Fluid Bed Granulation Process Diagnostic, up-flow air distribution for environmental control, test facilities for freeze-drying, humidity and particle control, a negative pressurization area for contagious-disease research, and more.

“Continuous improvement” and “creating value” aren’t mere management-speak. They have specific meaning and real application that can improve quality, ensure compliance and boost your bottom line more than 25 per cent. Jump on the lean-management train now. Competitors will never know what hit them. Sign up today.

January 30, 2018


Bringing Innovative Consumer Products to Market - FDA’s Evolving Regulation of Software and Other Consumer Products

1:30 PM - 3:30 PM Eastern

Deep within the still-new 21st Century Cures Act lies a clause that could alter FDA medical device regulation in ways no one can yet know ... and have implications far beyond companies now subject to FDA regulation.

That clause, Sec. 3060, redefines “medical device” to exclude significant software functions. In doing so, it may limit FDA regulation of consumer products when they are associated with health and wellness claims — products such as smartwatches that can measure bodily functions.

How will your products — not to mention products you may develop in the future, from “smart” monitors to wearables to ??? — be affected?

The FDA plans to issue guidances, possibly in the coming quarter, clarifying how it sees its authority changing under Sec. 3060. Will your profits suffer ... or benefit? You need answers now.

Mark your calendar for an hour and a half with a legal expert who’s given such questions deep thought. Michael M. Gaba Esq. starts with the FDA’s risk-based classification system that has been in place for decades, then invites you to look into his crystal ball:
  • How the 21st Century Cures Act may set new limits on the FDA’s authority by redefining “medical device” to exclude significant software functions
  • What the agency must do to harmonize its guidance with current law and how this could affect your regulatory decision-making in the interim
  • The urgent need to re-evaluate existing and planned products for which you make health and wellness claims
  • And much more!

Sec. 3060 has the potential to remake medical device regulation, as well as bringing many companies under FDA regulation for the first time. Whether you face FDA regulation now or envision it down the road, the time to get up to speed is right now. Sign up now.

January 31, 2018


How to Build A World-Class Audit Team - The Key to Avoiding FDA Enforcement

1:30 PM - 3:30 PM Eastern

Meet Susan Schniepp. She’ll show you how to avoid warning letters ... maybe forever.

The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud.

Not following SOPs. Data integrity and good documentation practices. Incomplete investigations. Ms. Schniepp, a QA expert and award-winning author with 35 years’ experience, walks you through the steps that counter such errors and teaches you:
  • Elements of an effective audit program, including naming members who not only know SOPs, but know whether you’re really following them
  • Better utilizing internal audit observations to drive continual improvement and remediate shortcomings before it’s too late
  • Qualities of effective auditors and team leaders — and how to spot them
  • Good documentation practices — the best prevention against warning letters and other regulatory headaches
  • And much more!

Isn’t the prospect of avoiding warning letters and Forms 483 — possibly forever — worth 90 minutes of your time? Of course it is.

February 8, 2018


Regenerative Medicine - Understanding FDA’s New Approach to the Regulation of Stem Cells and HCT/Ps

1:30 PM - 3:30 PM Eastern

The FDA has thrown out 25 years worth of regenerative-medicine regulation. In November the agency issued new rules aimed at clearing a path to market for new therapies.

But the ink is barely dry, and pitfalls exist. Right now, wouldn’t it be great to have a knowledgeable lawyer guiding your way?

Mark your calendar for 90 minutes in the company of such a lawyer. Andrew Ittleman Esq. represents physicians, hospitals and manufacturers in this booming area. He has litigated extensively against the FDA regarding scope and reach of the Part 1271 regulations.

Mr. Ittleman’s focus will be FDA’s new regulatory approach: Best practices for you to follow for compliance with laws, regulations and policies. You’ll discover:
  • How the FDA is interpreting “homologous use,” “minimal manipulation” and “same surgical procedure”
  • Parameters of the FDA’s 36-month enforcement discretion
  • About the FDA’s NEW RMAT pathway
  • About regulation of devices commonly used in regenerative medicine
  • And much more!

The FDA’s RMAT regulations offer both promise and peril, and these rules still are so new you need help sorting them out. This is the moment to get the help you need — without paying exorbitant legal fees. Sign up today.