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 ONE | MONDAY, NOVEMBER 13

7:00 REGISTRATION & MORNING COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS

LIVE POLL: ANONYMOUS TEXT RESPONSE
How many years of experience do you have in Clinical Quality?

 

8:00 KEYNOTE: REINVENTING CLINICAL QUALITY PRACTICES
Traditionally, quality assurance has been retrospective in its practices and procedures, but over time regulations have evolved to reflect a more holistic and cross-functional approach to quality. In turn, clinical quality teams have joined in the paradigm shift by implementing proactive steps to identify and mitigate quality risks throughout all phases of clinical studies. A seasoned clinical quality executive will kick off the conference with an inspiring keynote presentation, encouraging attendees to consider how clinical quality has evolved over the years and how CQA teams can continue to be at the forefront of innovation and change.

Andy Lee, SVP, Head, Global Clinical Trial Operations, MERCK

 

8:45 PANEL: EMBRACING THE CHANGES WITHIN THE REVISED ICH GCP GUIDELINES
The goal of the updated ICH E6 R2 guideline is to push pharmaceutical companies to have a more holistic approach to the clinical quality management system, with quality by design principles and risk-based monitoring serving as the foundation for the addendum. Many clinical quality teams have placed a major focus on the implementation of risk-based monitoring; however, the ICH addendum addresses much more than RBM practices, and it is vital that pharmaceutical companies adapt the entire quality management system in order to truly be aligned with the revised guideline. This panel will review each modification in the ICH E6 R2 addendum and walk attendees through an interactive discussion on the various evaluations that must be performed to comply.

  • Interpreting the updated ICH E6 R2 guideline
  • Performing a gap analysis to ensure alignment
  • Implementing quality by design principles
  • Objective: cross-functional & metrics-based clinical quality

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

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

Mary V. Fleres, Senior Manager, Global R&D Quality, ALLERGAN

Frances Gavigan, Associate Director, Clinical Quality Assurance, ADVAXIS

Dwayne Brazelton, Director, Clinical Quality Assurance, MACROGENICS

 

9:30 COFFEE & NETWORKING BREAK

 

LIVE POLL: ANONYMOUS TEXT RESPONSE
How confident do you feel in your team’s risk-based approach for clinical quality?

 

10:00 TRANSCELERATE’S CLINICAL QMS INITIATIVE: DEVELOPING THE FRAMEWORK FOR A CQMS TO PROMOTE A CULTURE OF QUALITY

  • Defining a clinical quality management system
  • Understanding the benefits in alignment with ICH E6 R2
  • Recognizing the flexibility of the TransCelerate Conceptual Framework
  • Evaluating available TransCelerate QMS publications & tools
  • Developing tools & publications for future industry consideration
  • Examples from the TransCelerate team of experiences in voluntary adoption of the CQMS Conceptual Framework

Mary V. Fleres. Senior Manager, Global R&D Quality, ALLERGAN

 

10:45 CASE STUDY: IMPLEMENTING A RISK-BASED MONITORING PROGRAM

  • Moving away from a 100% monitoring philosophy to risk-based
  • Development of a risk management process based on resources
  • Aligning cross-functional areas with a new risk-based approach

Frances Gavigan, Associate Director, Clinical Quality Assurance, ADVAXIS

 

11:15 INSPECTION READINESS: DEFENDING A RISK-BASED APPROACH

  • Addressing varied interpretations of a risk-based approach
  • Documentation of the risk management process in clinical quality
  • Metrics utilized to measure and address risks in clinical quality

Michael London, Director, Quality Assurance GCP/CSPV, DAIICHI SANKYO

 

11:45 RISK-BASED MONITORING SMALL GROUPS: FINDING BEST PRACTICES
During this segment, each small group discussion will address a specific challenge within the implementation and execution of a risk-based approach to clinical quality.

  • GROUP 1:
    Implementing a clinical phase-based approach for risk management
  • GROUP 2:
    Resource allocation to adequately execute risk-based monitoring
  • GROUP 3:
    Sufficient documentation to overcome regulatory scrutiny of RBM
  • GROUP 4:
    Novel approaches for applying a risk-based management in clinical QA

Reb Tayyabkhan, Vice President, Head, Global Data Strategies & Solutions, BRISTOL-MYERS SQUIBB

Dwayne Brazelton, Director, Clinical Quality Assurance, MACROGENICS

 

12:15 LUNCHEON FOR ALL ATTENDEES

 

LIVE POLL: ANONYMOUS TEXT RESPONSE
How much time does your team spend in preparing clinical sites for GCP inspections?

 

1:45 CLINICAL QUALITY TRENDS: EVALUATING RECENT FDA BIMO OBSERVATIONS & WARNING LETTERS
Pharmaceutical companies can find incredibly valuable information from published 483s and warning letters, as they provide clinical quality teams with insight into common pitfalls that other manufacturers have encountered during an FDA BioResearch Monitoring (BIMO) audit. These findings can guide a risk-based monitoring program by pinpointing FDA focus areas within a GCP inspection. Through the review of recent FDA-issued observations, this presentation will offer attendees a roadmap for a risk-based clinical quality strategy to avoid FDA audit triggers.

  • Reviewing 483s and warning letters issued by the FDA
  • Identifying and addressing common clinical quality citations
  • Incorporating FDA BIMO “hot button” audit findings into monitoring

Bev H. Lorell, MD, Consultant, KING & SPALDING

 

2:30 EFFECTIVE PREPARATION FOR GCP INSPECTIONS
At any moment, FDA or other regulatory agencies can decide to con¬duct a GCP inspection, and it is absolutely crucial that clinical teams are always ready for an inspection. Observations found by a health authority can impact a clinical trial, whether it be an observation that occurred at the sponsor or one that occurred at a clinical site monitored by a CRO or the sponsor. With her previous experience as an FDA inspector but also with Pfizer and Merck on the pharmaceutical industry side, Christina DeLuca will be able to provide attendees with a unique perspective on how to best train and prepare clinical teams for a clinical quality inspection.

  • Inspection readiness vs inspection preparation
  • Similarities & differences in expectations from health authorities
  • Outlining preparation activities to ensure optimal outcomes

Christina N. DeLuca, Associate Director, GCP Inspections Lead, MERCK

 

3:15 COFFEE & NETWORKING BREAK

 

LIVE POLL: ANONYMOUS TEXT RESPONSE
What is most important in developing an effective partnership with a CRO?

 

3:45 CASE STUDY: HIGHLIGHTING AN EFFECTIVE PARTNERSHIP BETWEEN A PHARMACEUTICAL COMPANY & CRO

  • Clearly communicating expectations for a partnership
  • Identifying areas of improvement to ensure clinical quality
  • Collaborating with a CRO to progress clinical quality procedures
  • Results: good communication, data integrity & trust in partnership

Katherine Tygum Goldstein, Senior Director, Quality Operations (GCP) R&D Quality & Compliance
ALEXION PHARMACEUTICALS

 

4:30 PANEL: CREATING A COLLABORATIVE ENVIRONMENT FOR PHARMA & CRO PARTNERSHIPS

  • CRO perspective on managing clinical studies
  • Handling CAPA investigations and alerting sponsors
  • Common pitfalls and trends in clinical quality
  • Ensuring high quality data in clinical research
  • Keys to a productive & reliable CRO/pharma relationship

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

PANELISTS:
Billy Dirkes, Senior Director, Internal Audits, Quality Risk Management, PPD

Neil McCullough, EVP, Quality & Compliance, ICON PLC

 

5:00 COCKTAIL HOUR SPONSORED BY: Q1 PRODUCTIONS

6:00 END OF DAY 1 CONFERENCE ACTIVITIES

FACILITATED GROUP DINNERS:
Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on Monday, November 13.

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