With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision to the ICH Guideline for Good Clinical Practice (E6 R2) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. With the pending adoption of these revised guidelines, it’s time to evaluate how your organizational structure and processes will be affected.
Key discussion points:
- The changes to the guideline, particularly regarding how they affect quality management and risk-based monitoring
- Suggestions for interpreting the guidelines and how they specifically affect your organization
- Considerations when implementing the guidelines
Kristin Mauri, MBA, Senior Director, Global Consulting, eHealth Solutions, Bioclinica
Kristin Mauri heads Bioclinica’s global Risk-Based Monitoring (RBM) practice and Compass solution. Ms. Mauri brings more than 20 years of clinical project management experience and eClinical technology implementation for pharma, biotech and CRO organizations. Prior to joining Bioclinica, Ms. Mauri was the Director, Product Strategy at Oracle Health Sciences where she was responsible for growing both the technology partnership program, as well as leading the risk-based monitoring strategy. A recognized thought leader and industry speaker, Ms. Mauri has presented extensively on clinical trial forecasting and budgeting within the realm of emerging eClinical technology. Ms. Mauri’s educational credentials include an MBA from Lake Forrest Graduate School of Management, MGH Boston master’s program coursework in Clinical Investigations and a bachelor’s degree from Pennsylvania State University.
Who Should Attend?
Senior professionals from phama and biotech companies interested in learning more about the ICH e6 R2 revisions and the impact it will have on their organizations –
- Directors of Data Management
- Directors of Clinical Operations
- Study Managers
- Project Managers
- Central Monitors
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with financial lifecycle, safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.
Bioclinica’s Post-Approval Research division, a niche specialty clinical service provider, is dedicated exclusively to post-approval research. Our focus is in designing and conducting post-approval research for observational studies, post-marketing commitments, and large, simple trials. We also provide unparalleled expertise in post-approval safety studies. We offer comprehensive, innovative, technology-driven, cost-effective solutions with full-service capabilities for Pharmaceutical, biotech, and medical device companies.