Tag: regulatory

Medical and Regulatory Affairs

The Role Of Notified Bodies Under The EU Medical Devices Regulation

The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical...

Medical and Regulatory Affairs

A Security Plan For All Stakeholders Involved In Digital Medicine: What Device Manufacturers Need To Know

Connected medical devices, like all other computer systems, are vulnerable to threats that may lead to compromise of data confidentiality, integrity, and availability. To address these challenges, the Healthcare and Public Health Sector Coordinating Council (HSCC) Joint Cybersecurity Working Group recently issued the Medical Device and Health Information Technology (IT) Joint Security Plan (JSP). [1] This new...

Global Compliance

Strategic Planning for Compliance With the EU Medical Device Regulation

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance. Establishing a leadership team Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanisms...

Consulting

FAQ: How the EU Medical Devices Regulation Affects Existing Products

With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance. Is it possible to avoid compliance with the EU MDR? The short answer...

Medical and Regulatory Affairs

The FDA’s New Guidance on Natural History Studies in Rare Diseases: What You Need to Know

In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases. The document, Rare Diseases: Natural History Studies for Drug Development,[1] addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lack...

Global Compliance

Data Protection Part 3: Key Considerations for Clinical Trial Recruitment

With the advent of the EU’s General Data Protection Regulation, individuals now have expanded rights to information regarding the use of their personal data. These changes impact several aspects of the clinical trial recruitment process and may require sponsors and CROs to update their data collection and protection protocols and processes for informed consent. Consent...

Consulting

Regulatory Oversight on Gene Therapy in the U.S. and EU

Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. The approvals of voretigene neparvovec-rzyl (Luxturna) for inherited vision loss, tisagenlecleucel (Kymriah) for lymphoblastic leukemia, and axicabtagene ciloleucel (Yescarta) for lymphoma have ushered in a new era of therapeutics. With the rapid evolution of the...

Medical and Regulatory Affairs

Premier Research Names New Medical Device Research And Regulatory Process Experts

DURHAM, N.C., March 8, 2019 — Premier Research has added key expertise to its global CRO operations by naming three new medical device and diagnostics specialists. Joining Premier Research are Vicki Gashwiler as executive director of clinical development services, medical device and diagnostics; and Sundeep Shrivastava as executive director of clinical development services, medical device...

Global Compliance

Data Protection Part 2: Ensuring Study Start-Up Compliance With GDPR

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blogpost, we focus on four GDPR articles that are relevant to study start-up. Article 131 As the data controller, the sponsor must provide a privacy notice...

Data Management & Biostatistics

3 Key Takeaways on Choosing the Right Committee for Medical Device Trials

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency...