Managing Global Regulatory Strategy & Compliance: Assessing Status, Gaps, and Needs - Webinar

Описание: Based on May 2024 medical devices regulatory survey data, four industry SMEs discuss medical device regulatory intelligence, current industry skill sets, and resource challenges. The data suggests a growing level of global regulatory complexity has led to industrywide compliance resource constraints and bandwidth pressure. Our panel discusses how technology such as AI, key areas of regulatory skills development, and outsourcing expertise can help bridge your compliance gaps and build your team's internal regulatory intelligence.

In today’s fast-evolving regulatory environment, maintaining a robust global regulatory strategy and ensuring compliance is more critical than ever. A recent regulatory audience survey, conducted in partnership with Medtech Intelligence (MTI), revealed significant gaps in regulatory expertise and compliance processes within the medical device industry. Only 6% of respondents reported comprehensive regulatory expertise and processes, while nearly one-third indicated adequate processes but insufficient comprehension of changing requirements.

This webinar will address these pressing challenges. Our panel of industry experts will explore the findings of recent research, explore the shifting regulatory landscapes, and identify critical gaps. They will also share valuable insights on how to enhance regulatory intelligence and mitigate compliance deficits through knowledge, technology, and resources.

Webinar Panelists
Dr. Pratibha Mishra, Senior Manager – Medical Device Services, Celegence
Erin Cosgrove, VP, Business Development – Medical Devices, Celegence
Ibim Tariah, Ph.D., Technical Director – Medical Devices, SGS North America Inc.
Gregory Jacobson, Sales Director – Medical Devices, SGS North America Inc.

Key Learning Objectives
1. Identify Regulatory Gaps: Understand why gaps in regulatory intelligence and compliance processes are overwhelming for teams and organizations.
2. Risk Mitigation: Learn strategies to mitigate risks associated with the growing complexities of global regulatory compliance.
3. Focus Areas: Discover where to prioritize MDR/IVDR efforts and investments.
4. Technology and Resources: Explore technologies and resources for cost-effective management of current bandwidth limitations in the industry.

Celegence – Regulatory Services and Solutions to Support the Medical Devices and Diagnostic Industry

Celegence offers regulatory solutions and services that are tailored to the needs of medical devices and In Vitro Diagnostics (IVD) manufacturers. The benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered costs, and ongoing regulatory compliance.

For further regulatory assistance or queries on how Celegence can support your organization, reach out to [email protected] today.