Regulatory Posts

Simplifying Today’s Regulatory and Compliance Complexities

Simplifying Today’s Regulatory and Compliance Complexities

Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA

The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.

In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey). (more…)

EU GDPR: Are You Ready? Is Your Quality Management System, Too?

EU GDPR: Are You Ready? Is Your Quality Management System, Too?

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

EU GDPR — The Week is Here!

The General Data Protection Regulation (GDPR), approved by the European Parliament and Council in April 2016, replaces the Data Protection Directive 95/46/ec at the end of this week, on May 25, 2018. It will become the primary regulation protecting all European Union (EU) data subjects from privacy and data breaches in a world driven by data — a world very different from the time in which the 1995 directive was established. (more…)

Florida Medical Manufacturers Consortium: 2018 Symposium Update

Florida Medical Manufacturers Consortium: 2018 Symposium Update

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Established in 2003, the Florida Medical Manufacturers Consortium (FMMC) strives to unite, promote, and grow Florida’s Medical Device Industry and enhance the business success of its member companies. To that end, every year the Consortium hosts a Symposium to allow for industry networking, the expansion and sharing of industry knowledge and expertise, and to update its members on advocacy activities.

FMMC’s current advocacy activities occurring at the state and national level include:

  • Supporting Florida legislation fully exempting the purchase of manufacturing equipment (MME) from sales tax
  • Backing proposed legislation to reduce Florida’s sales tax on commercial rent
  • Working with national, regional, and industry advocacy groups in the fight to repeal the medical device excise tax

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Be Aware! Security Training and Employee Engagement

Be Aware! Security Training and Employee Engagement

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions, an IQVIA company

As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of employee security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
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Strategic Planning for the In Vitro Diagnostic Regulation (IVDR). Have You Spoken to Your CEO Yet?

Strategic Planning for the In Vitro Diagnostic Regulation (IVDR). Have You Spoken to Your CEO Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

Despite having a longer transition of five years compared to the three years for the EU Medical Devices Regulation (EU MDR), the In Vitro Diagnostics Regulation (IVDR) provides IVD manufacturers with a much higher hurdle to jump over than the EU MDR1 for “general” IVD manufacturers. Due to this higher hurdle, IVD manufacturers must not sit back and wait for the commotion of the MDR to die down before implementing their transition.

Adding to the pressure of the May 2022 IVDR transition deadline, other, even shorter deadlines should force IVD manufacturers into action sooner. These include Health Canada’s mandate for adherence to the Medical Devices Single Audit Program (MDSAP), and the end of transition of EN ISO 13485:2016. (more…)

Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Strategic Planning for the EU Medical Devices Regulation: Have You Spoken to Your Notified Body Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

We are now almost one-third of the way into the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR).

The MDR has significant economic impact on manufacturers — not just the cost of implementing the new regulations for new products, but ensuring legacy products meet the new requirements, as there is no grandfathering from the current EU Medical Devices Directive (MDD). The MDR has a big impact on distributors and importers, as well as manufacturers. This means that some distributors/importers (Economic Operators) of CE-marked products may cease their involvement under the MDR. The medical device supply chain is quite complex, often with involvement of multiple distributors, from manufacturers to patients. It is a global issue, as it affects all manufacturers/distributors that sell in to the EU.
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The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions, an IQVIA company

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?
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Validated Cloud Solution… absolutely!

Validated Cloud Solution… absolutely!

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

Life Sciences organizations are progressively searching and shifting to cloud-hosted environments to increase efficiency and reduce costs. But to do so, those organizations must be able to select a cloud service provider that helps to assure the confidentiality, integrity, and availability of data stored in the cloud.

Cloud-hosted environments help Life Sciences organizations with validation challenges and ease the process of qualifying cloud infrastructure with emerging capabilities and tools. In addition to the methods and controls to support the achievement of continuous quality and regulatory compliance, these organizations are seeking ways to maintain their Quality Management Systems (QMS) in a secured and validated state.
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Real World Data and Evidence: Promise of Improved Patient Outcomes

Real World Data and Evidence: Promise of Improved Patient Outcomes

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

During the 12th Annual Conference for the Business of Biotech, held at the Moffitt Cancer Center in Tampa, Florida on March 2, 2018, it was no surprise that the theme of the conference was Discovering Tomorrow’s Cancer Cures. With the keynote on Immunotherapy and the impact it’s having on the treatment of cancer, as well as discussions on Adaptive Therapies, and breakthroughs made possible by the 21st Century Cures Act, one could feel the promise of recent and near-future advancements in the fight against cancer.

With all the science-based presentations at the conference, the session titled Real World Data: Mining Gold from a Mountain of Straw drew my attention. The session focused on Real World Data (RWD) and Real World Evidence (RWE), and how to draw insights from both to improve patient outcomes.
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eMDR and UDI AS2 Gateway Messaging: Be Aware of Unintended Consequences

eMDR and UDI AS2 Gateway Messaging: Be Aware of Unintended Consequences

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Keeping on top of regulatory updates is an ongoing challenge. Regulatory bodies are constantly making updates and Life Sciences organizations are expected to interpret these guidelines and fold them into their existing quality and compliance systems. We’re all aware that the cost of misinterpreting or ignoring these updates is high. That’s why it’s important not only to monitor these updates, but also to closely examine them for unintended consequences to the rest of your quality and regulatory processes. In this post, we’ll examine a recent update to FDA electronic submissions and shine a light on some unintended consequences and potential missed communication from this update.
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