expert insights webinars
Award-winning experts share their detailed and actionable insights to inform the future of pharma, biotech, and medical devices
Expert Insights webinars, presented by MMS
The Expert Insights webinar series offers free learning opportunities on current trends, high-value topics, and complex initiatives in the evolving pharmaceutical, biotechnology, and medical device industries. Current and archived webinars are available as follows:
Effective anonymization at the intersection of process and technology (January 27)
The propagation of advanced data analytics has made information sharing more important than ever. Anonymization of clinical artifacts – whether data, documents, images, or other – is a critical component allowing researchers to share meaningful data without needlessly jeopardizing patient privacy or exposing company confidential information (CCI).
In this webinar, attendees will:
- Learn how cutting-edge technology and data-driven processes combine to expedite this effort
- Explore how machine learning techniques can be applied to accurately identify subject-identifying text in PDF documents
- Evaluate risk assessment techniques, both qualitative and quantitative, and how they apply to each artifact
Kelly Vaillant, Director, Global Transparency Strategy & Compliance
Zach Weingarden, Senior Manager, Product Solutions
Quality Control of Regulatory Documents: Best Practices to ensure a First-Time Quality Approach (February 18)
The concept of regulatory document quality in the pharmaceutical industry derives, in part, from the idea of “scientific data integrity” set out in good clinical practice (GCP) guidance. In practice, the concept of document quality in this regulatory context is structured around key elements that include writing that is clear, precise, concise, consistent, and sound scientifically. Achieving these key elements requires the development and adherence to strict working practices by individuals with the highest levels of expertise.
In this Expert Insights webinar, MMS will explore the challenges and pitfalls of ensuring documents for regulatory audiences are high quality, without error and fit for purpose. Attendees will understand:
- The parameters that define document quality
- How to create processes that foster an environment of “first-time quality”
- Who should be the gatekeepers of quality?
- Balancing idealism and pragmatism in quality control
- Changes to the way QC teams are working including emerging QC innovations
- Methods in use to measure document quality
Jim Newman, Senior Manager, Regulatory & Medical Writing (UK)
Ravi Kishore Kandula, Team Lead – Quality Control (Bangalore, India)