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Risk-Based Quality Management

Risk-Based Quality Management

Categories

Date of beginning

Wednesday, 02 December 2020

Duration

2 days

City

Virtual

Country

United States

Contact

Joanne Driscoll

E-Mail

This email address is being protected from spambots. You need JavaScript enabled to view it.

Memo

On December 2-3, 2020, leading clinical professionals will be coming together online for the 8th annual Risk-Based Quality Management (RBQM) conference to discuss the latest insights and solutions for improving data quality and streamlining the path to compliance. Join an expert speaker line-up for case study examples on how to extract higher quality data, discover new technologies and implementation strategies, and get to grips with the latest regulatory guidance for RBQM. Benefit from focused virtual discussion and live Q and As by putting your questions forward for tailored feedback, as well as the flexibility to re-watch content in your own time with 30-days of on-demand presentation access following the live event. Plus, schedule one-to-one video meetings with fellow attendees to connect with your RBQM community and have the conversations you need to progress. Highlights include: • Join a panel debate exploring the state of the industry with multiple stakeholder perspectives from CluePoints, Merck Research Laboratories, Risk-Based Approach Ltd. and more. • Put your questions to the panel: Success strategies for de-risk, data quality and audit and inspection. • Discuss innovative approaches to remote monitoring during and post-COVID-19.• Master the concept of quality in clinical trials with inside insights from Ann Meeker O'Connell, Vertex (formerly FDA). • ICH E8 and ICH E6v3 revisions: What do these updates mean for your clinical strategy?• COVID-19 pandemic response: Explore the challenges faced and what has been learned from multiple stakeholder perspectives. • Benchmark with new technologies including AI/machine learning and it's impact on RBM through deep-dive case studies. Register early to save and secure your place to gain the information and contacts you need to optimize your RBQM approach. Prices:Pharma or Biotech Manufacturer: USD 999.0,Supplier / Vendor / CRO / Technology Provider / Consultant: USD 1899.0 Speakers: Mary Arnould, Director at Astellas Pharma, Christopher Biddle, Associate Director, Risk Management and Central Monitoring at Janssen Research, John (Jay) Daly, Clinical Study Risk Manager, Clinical Data Operations, Technology and Standards at UCB Biopharma, Laureen Dorschel, Clinical Data Manager at UCB Biopharma, Esther Huffman O'Keefe, Associate Director, Monitoring, Global Clinical Operations at Regeneron, Andy Lawton, Director at Risk-Based Approach Ltd, Ann Meeker O'Connell, Vice President, Integrated QMS/OMS at Vertex Pharmaceuticals, Amy Neubauer, Director, Data Quality Oversight at Alkermes Inc., Rosanne Petros, PMP, Associate Director, Clinical Research at Merck Research Laboratories, Craig Reist, Ph.D., VP and Chief Scientific Officer at 2M Clinical, Michael Walega, Head of Centralized Monitoring at Bristol Myers Squibb, Steve Young, Chief Scientific Officer at CluePoints Time: 10:25 am - 2:55 pm