Global Compliance
Clinical Research: Phase 1 - Phase 4
Achieving the Promise of Gene Therapy: New Pathways to Overcome Patient Enrollment and Safety Challenges, Upcoming Webinar
TORONTO (PRWEB) SEPTEMBER 15, 2020 Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine. This webinar will examine the evolving...
Consulting
Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA). The eCTD harmonizes the regulatory review process for global drug development, as its structure is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
Consulting
IEEE Spectrum: Cyber attacks on Medical Devices Are on the Rise—and Manufacturers Must Respond
Cyberattacks are increasingly common in the health care industry. As the number of networked medical devices increases, so does the urgency for makers of these devices to understand and mitigate threats to device security. In an increasingly interconnected and digital world, more and more medical devices contain embedded computer systems, which can be vulnerable to...
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...
Clinical Research: Phase 1 - Phase 4
Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research
Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of...
Consulting
Medical Design & Outsourcing – Medical device cybersecurity: It’s time to get real
Medical Design & Outsourcing – Medical device cybersecurity: It’s time to get realcontribution by John Pappan, Director of Regulatory Affairs, Medical Device & Business Strategy
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...