2018 Quality Congress Agenda

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Friday, April 27 | 8:30am-5:00pm

Key Topics

  1. Patient-Centered Clinical Trials: Progress, Gaps, and Opportunities
  2. Creating a Quality Culture and the Benefits of Implementing Holistic Quality Management Systems
  3. Operationalizing Risk-Based Approaches in Light of Regulatory Mandates and Inspection Preparedness
  4. The Growing Complexity of the Clinical Trial Ecosystem and Consequences of Effective Oversight
  5. Improving Quality Through Effective CRO/Sponsor/Site Partnerships

 


Schedule

8:30-9:00am
Registration and Continental Breakfast

9:00-9:45am
Session 1:  Welcome and Review of AQC and ACRP Initiatives and Partnership Goals

9:45-10:45am
Session 2: Clinical Trials, The Growing Complexity of the Clinical Trial Ecosystem

9:45-10:05am
This session will begin with a data-driven discussion of the disconnect within the key players of the clinical trial ecosystem. The disconnect between Sponsors, Providers and Sites as well as within departments of each of these organizations proves that there is a need to stabilize the industry understandings across the rapidly changing ecosystem. The role that is critically involved with all of these players is the Clinical Research Associate. ACRP has developed a set of core competencies that will help to address the variability of an important role within clinical research.  

10:05-10:45am
The session will progress through a panel of site, sponsor and CRO representatives that discuss how we bridge the learning gaps in a rapidly changing environment across multiple roles in clinical trial execution.  Questions for the panelists may be entered through the Conference I/O System.

10:45-11:15am
Networking Break

11:15am -12:30
Session 3: Operationalizing Risk-Based Approaches in Light of ICH E6 (R2) and a Focus on Inspection Preparedness Across the Entire Clinical Trial Ecosystem

11:15-11:35am
Overview of ICH E6 (R2) and how it impacts, Sponsors, CROs and Sites.

11:35am-12:00pm
This interactive session will breakout into table sessions to review ongoing efforts to expand and enhance the content and robustness of the AQC Inspection Readiness and Preparedness Knowledge Center to include site centric leading practices, tools and inspection site experiences. Each table will discuss the opportunities for improvement surrounding the topic they were provided.

Topics of Discussion:

  • Site Inspection Preparation Tools
  • Site Inspection Experiences
  • Differences between risk based approaches at Site vs Sponsor/CRO level

12:00-12:30pm
A panel of Sponsor, CRO and site executives who will respond to the highest ranked suggestions captured within Conference I/O from the interactive table sessions.

12:30-1:45pm
Networking Lunch & Presentations by Workforce Innovation Award Finalists

1:45 -2:30pm
Session 4:  Improving Quality Through Effective Partnerships

The Avoca Group has focused on increasing the quality and efficiency of clinical trials while decreasing the risk by focusing on Sponsor/CRO partnerships. This panel will discuss how quality is impacted through partnerships between sites and Sponsors/CROs and what we can do as an industry to improve these partnerships.

2:30-3:30pm
Session 5: Creating a Quality Culture and the Challenges of Implementing Holistic Quality Management Systems

2:30-2:50pm
This session will discuss the key components that the Avoca Quality Consortium has identified as necessary to having a holistic Quality Management System

2:50-3:30pm
This session will include an interactive activity at the tables where each table is assigned a component of the proposed holistic site quality management system.  The groups will then define the rationale behind that component as well as helpful concepts for guidelines, templates and tools that could be developed as part of the site holistic quality management system.  Towards the end of the exercise, moderators will share the insights of each of the tables to the larger group for discussion.

3:30-4:00pm
Networking Break

4:00-4:45pm
Session 6: Clinical Trials, The Patient Perspective
The session will progress through a panel, patient, Sponsor, CRO, site, which focuses on how patients and their support systems experiences in clinical trials have progressed, gaps that should be closed with consideration to the patient experience and lastly opportunities where the pharma and CRO players can take the investigative site experiences and advice to create a greater focus on the patient experience.

4:45-5:00pm
Close of Event

5:00-6:30pm
Please Join Us for the Expo Opening Celebration (Event Details)

6:45-8:30pm
Please Join Us for the ACRP/Avoca Awards & Recognition Ceremony (Event Details)


Extend Your Stay and Enjoy So Much More...

Keep the momentum going by extending your time at ACRP 2018. Full Conference and Weekend registration options enable you to take advantage of all ACRP 2018 has to offer.