PHARMACEUTICAL CLINICAL QUALITY COMPLIANCE AND RISK MANAGEMENT CONFERENCE

NOVEMBER 13-14, 2017 | ALEXANDRIA, VA

COURTYARD BY MARRIOTT ALEXANDRIA PENTAGON SOUTH

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DAY TWO | TUESDAY, NOVEMBER 14

7:30 REGISTRATION & MORNING COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS

LIVE POLL: ANONYMOUS TEXT RESPONSE
What was your biggest takeaway from yesterday’s sessions?

 

8:00 PROPERLY MEASURING SERVICE QUALITY AS A RISK MANAGEMENT TOOL
Clinical trial quality is directly related to the service quality delivered by sponsors, CROs, investigative sites, and to patients. The risk associated with these interactions manifests itself across the entire trial, driving the lagging time and quantity data reported by key performance indicators. The good news is that clinical trial service quality can be rigorously and efficiently measured. This presentation reviews the primary components of service quality-based risk management, discusses how they help address the updated ICH guideline along with FDA’s continued scrutiny of clinical research operations, and provides data from a recent ACRP initiative as an example of the technique.

Peter Malamis, Collaborator, ACRP

 

8:45 MAINTAINING AN INSPECTION-READY TRIAL MASTER FILE
Although managing a trial master file may seem like a straight-forward process, clinical quality teams find that maintaining a trial master file in a constant state of inspection readiness proves to be a challenging endeavor. Regulatory observations and warning letters oftentimes cite insufficient documentation within a trial master file, further motivating pharmaceutical companies to evaluate current practices for keeping a TMF up-to-date. Whether it is a paper-based or electronic system, implementing a robust SOP for managing a trial master file is crucial to ensure proper ongoing documentation of clinical trial data and procedures.

  • Compliance with regulatory guidelines for trial master files
  • Developing SOP for updating a trial master file
  • Training clinical site teams on documentation practices

Charlene S. Atkinson, Associate Director, Clinical Quality Assurance, AMICUS THERAPEUTICS

 

9:30 COFFEE & NETWORKING BREAK

 

LIVE POLL: ANONYMOUS TEXT RESPONSE
What is your biggest regulatory concern as it pertains to clinical quality?

 

10:00 CONDUCTING ROOT CAUSE INVESTIGATIONS & IMPLEMENTING CAPA FOR CLINICAL QUALITY
Oftentimes, training on CAPAs and root cause investigations are centered on GMP, and clinical quality teams find the need for training specifically tailored to the clinical setting. From proper documentation within the trial master file to adequate training of clinical site teams, variances in a CAPA process exist from the GMP to GCP environment. This presentation will offer attendees an opportunity to hear best practices for what is truly necessary to manage a thorough root cause analysis and implement an appropriate CAPA within the clinical realm.

  • Proper identification of root cause
  • Deploying effectives CAPAs in clinical studies
  • Mitigating risk after CAPA implementation
  • Systems utilized to track CAPAs in a clinical setting

Pattie Skeens, Associate Director GCP/GLP/GVP QA, TESARO

 

10:45 ADDRESSING THE INCREASED FDA SCRUTINY OF DATA INTEGRITY
In April 2016, FDA published a guidance outlining expectations for data integrity in drug manufacturing, prompting pharmaceutical companies to review and align quality practices with the regulation. Although the name of the guidance clearly states CGMP as its focus, FDA has issued warning letters citing poor data integrity within clinical trials, specifically related to insufficient or incomplete documentation. As such, clinical quality teams must understand and comply with FDA expectations for ensuring reliable and accurate clinical data.

  • Regulatory agency focus on data integrity within clinical trials
  • Oversight of electronic systems to ensure data integrity
  • Insufficient documentation contributing to poor data management

Mahnu Davar, Esq., Partner, ARNOLD & PORTER KAYE SCHOLER LLP

 

11:30 THE EVOLVING AREA OF CENTRAL MONITORING: DATA REVIEW & RESPONSIBILITIES
As pharmaceutical and biotech organizations embrace the concept of using risk-based approaches to monitoring, many are exploring the central monitoring strategies to collect, analyze and review key risk indicators, data and performance metrics to monitor site performance and identify outlier sites that monitors and auditors need to explore further. This presentation will provide an overview of Central Monitoring industry survey results and discussions taking place in an industry consortium group comprised of representatives from sponsors, CROs, central labs and other core labs and IT Solution providers.

  • Understanding the concept of central monitoring
  • Implementing a central monitoring plan
  • Key risk indicators, data and performance metrics to review
  • Analytic approaches utilized by pharmaceutical companies
  • Roles and responsibilities in overseeing central monitoring

Linda B. Sullivan, President & Co-Founder, METRICS CHAMPION CONSORTIUM LLC

 

12:15 LUNCHEON FOR ALL ATTENDEES

 

LIVE POLL: ANONYMOUS TEXT RESPONSE
As we wrap up the conference, what is one new thing you plan to implement when you get back to your office?

 

1:45 AVOIDING TRIGGERS FOR FDA BIMO AUDITS
Robert S. Walsh, MD, MBA, FAHA, FCCP, Consultant
WALSH MEDICAL CONSULTANTS

 

2:30 SPOTLIGHT SESSION: QUALITY OF CLINICAL RESEARCH IN ACADEMIA

  • Managing quality in a university setting
  • Facilitating adherence to regulatory expectations
  • Improving QA and QC processes to achieve quality outcome in research
  • Developing constructive collaboration between academia and industry

Johanna Stamates, Executive Director, RCQA, UNIVERSITY OF MIAMI

 

3:15 PANEL: DEVELOPING CLINICAL QUALITY TEAMS THROUGH CONTINUED EDUCATION & LEADERSHIP OPPORTUNITIES

  • Certificates available to enhance clinical quality expertise
  • Influencing curriculum for advanced degrees to benefit the industry
  • Opportunities for continued education and leadership development

William Pickard, RPH, MS, Chairman, Department of Clinical Research, CAMPBELL UNIVERSITY

Andy Lee, Senior Vice President, Head,, Global Clinical Trial Operations, MERCK

Denise Ruby, MBA, RQAP-GCP, Senior Director, Clinical Quality Assurance, TAKEDA

 

4:00 END OF DAY ONE CONFERENCE ACTIVITIES

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