Implementing Risk-Based Quality Management (RBQM) – Lessons Learned and Key Pathways to Compliance

Clinical Trials, Life Sciences, Pharmaceutical Regulation,
  • Thursday, June 06, 2019

Two years ago the European Medicines Agency adopted the E6R2 guidelines for good clinical practice, reflecting a changing culture of risk-based quality management in the pharmaceutical industry. Both new and established pharma companies face challenges in implementing these guidelines into their existing clinical trial portfolios. Cloud-based technology offers several advantages to ensuring companies are compliant with those guidelines:

  • Capacity to share Quality Tolerance Limits data with sponsors and vendors to ensure risks are regularly updated, prioritized and reported
  • Engages clinical study teams, vendors and governance in maintaining and reviewing risks throughout the duration of the study
  • Capacity to couple with Change and Project Management techniques

In this free webinar, participants will hear about the journeys of two pharma companies in implementing risk-based quality management. In particular, the speakers will discuss the challenges faced, lessons learned and how technology can be leveraged for compliance. In this webinar we will will discuss how to structure a risk-based approach with study teams and the challenges in changing an industry which is expert in resolving issues rather than preventing them.

Speakers

http://Chris%20Panteli,Chaucer

Chris Panteli, Managing Consultant, Chaucer

Chris Panteli has 28 years of experience working internationally with Blue Chip and Subject Matter Expert (SME) organizations. Working as a consultant for the last 10 years, he has experience working in several different industries including pharmaceuticals, energy and aerospace. Having spent most of his career in pharmaceuticals, Chris has worked in most functions across the research and development process and has a unique understanding of the challenges facing the industry today. Most recently, he worked on risk-based quality assignments and created a technology-based solution for delivering E6R2 compliance. The solutions he provides are based on solid experience in delivering projects and change by effectively converting theory into practice to execute strategic objectives.

Chris is an accredited Change Agent and has worked closely with executive teams in portfolio and project management, developing and managing balanced scorecards, organizational alignment and risk management. He holds an MBA and a Bachelor of Science (Hons) in Engineering Product Design.

Message Presenter

Sarah Gunston, Senior Consultant, Chaucer

Sarah Gunston is an experienced Project and Change Manager who has helped companies embed new processes and ways of working. Currently, she is the Project & Change Management Lead working to embed a risk management process and framework to ensure compliance with ICH E6 (R2).

Sarah has worked on a variety of projects, engaging with leaders at all levels, giving her hands-on experience with a range of change initiatives, cultures, leadership styles and project management approaches. She is able to leverage this experience along with knowledge of industry best practice to work with organizations to develop a change approach that will deliver results and ensure that the new ways of working are sustained in the future.

Her qualifications include APMG Change Management Foundation & Practitioner, PRINCE2 Foundation & Practitioner and Lean Six Sigma Yellow Belt.

 

Message Presenter

Who Should Attend?

This webinar will appeal to individuals working in the following areas or with the following job titles:

  • Risk Management – Clinical, Regulatory, Quality
  • Quality Assurance and Management
  • Clinical Operations
  • Compliance
  • Audit & Inspection
  • Data Management
  • Vendor Quality Management

What You Will Learn

Participants will learn about:

  • Managing the change in culture required for risk-based quality management
  • Real life lessons learned from implementation of E6R2 (Case Studies)
  • Clarification of definitions around risk-based quality management
  • How technology can be used to improve engagement and effective reporting

Xtalks Partner

Chaucer

Chaucer is home to experts in creating value from digital transformation and data to improve lives.

We’ve been supporting the life sciences sector as specialists for 30 years. Our consultants have first-hand experience with everything from R&D through to Commercial – we understand the challenges that our clients face, as well as the opportunities for driving high impact change.

We specialize in Data and Technology, Data Enabled Operations, and Data Driven Transformation.

Chaucer is recognised by the Financial Times as a leading digital consulting company. Our entrepreneurial and innovative approach to our clients’ projects and programmes sets us apart. We serve as our clients’ trusted partner to ensure that even the most complex initiatives are delivered successfully.

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