Online Webinar 2019 - Risk-Based Quality Management Approaches in Clinical Trials - Webinar

Session Highlights
Critical steps for a successful implementation of a risk-based quality management approach
ICH Guideline Q9 “Quality Risk Management”
FDA Guidance for Industry “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” and dealing with the risk-based monitoring approach
EMA’s “reflection paper on risk-based quality management in clinical trials”
Key risk-based process/tools and techniques
Review a risk-based approach to protocol design
Understand risk-based approach to monitoring/data handling
Review guidance and papers regarding FDA Guidance and EMA Reflection Paper for clinical trial risk management and monitoring
Risk management activities required for all trials & includes both system and trial related risks
Seven stages of risk management and trial conduct should be proportionate to the inherent risks and importance of the information collected
Evaluate industry think tank trends
Review best practices for risk management for trial oversight and monitoring
Who will benefit
This webinar will provide valuable assistance and guidance to CRO’s, pharmaceutical, biotech and medical device firms. The employees who will benefit include: All levels of management and departmental representatives including:
Regulatory Affairs
Clinical Development Managers and Personnel
Clinical Research
Clinical Research Archiving and Document Management Personnel
Clinical Investigators and Staff
Clinical Research Associates
Study and Clinical Research Associate Managers
Sponsors/CROs Clinical Operations
Auditors
Consultants
Regulatory Affairs Specialists
Pharmacovigilance /Drug Safety
Study Site Personnel
Consultants
Overview
The concept risk management has been discussed in the context of clinical research now for several years. We will explain the importance of using risk management techniques in clinical research to comply with the requirements and expectations and certainly to prepare for any GCP. We will provide examples reflecting how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in your clinical trials. In addition, FDA and EU regulatory authorities support clinical trial sponsors in using risk-based site monitoring. Even FDA has stated that GCP Quality Systems should focus on high risk activities that: underpin data quality and integrity; ensure the integrity of conclusions drawn in a marketing application; and ensure human subject protections. A clinical QMS enables consistent and efficient delivery of reliable data that may be used by an organization, its partners, health authorities, health care providers, and patients to make informed decisions concerning medicinal products. Moreover, in a research setting, a clinical-focused QMS will enable the consistent conduct and appropriate oversight of research that is sound and ethical. This and more will be addressed during our session.
Speaker
David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and com