Risk-Based Quality Management Approaches in Clinical Trials

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

" Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry"

Clinical trial sponsors in using risk-based site monitoring


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.

Areas Covered

•      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

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

David R. Dills

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

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