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2nd European Clinical Quality Oversight Forum (exl)

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Location

Radisson Blu Portman Hotel

22 Portman Square

Marylebone

London

UK W1H 7BG

United Kingdom

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Refund Policy

No Refunds

Event description

Description

2nd European Clinical Quality Oversight Forum

Our inaugural European CQOF in 2016 attracted 100 clinical quality experts, with over 70% representing more than 45 different pharmaceutical, biotechnology, and medical device companies from all over the world. We are pleased to announce our 2nd European Clinical Quality Oversight Forum, taking place 26–27 February 2018 again in London. This interactive event focuses on ensuring trial integrity by effectively assessing, optimising and managing the quality of clinical vendors and sites and attracts clinical quality, operations, management and audit professionals to engage and candidly share their experiences, struggles, obstacles, and achievements when working with varying clinical partners including CROs and investigator sites. Learn from this experienced group and take away proven, results-driven, risk-based strategies for optimising your company’s clinical vendor and site oversight approach.

Top Five Reasons to Attend

  1. Learn from the industry’s leading clinical operations and quality experts from around the globe, as they candidly share their experiences, strategies and guidance for selecting and managing your clinical partners to ensure compliance and maximise performance
  2. Benchmark your clinical quality oversight strategy against other similar-sized companies to ensure your approach is optimal and effective
  3. Stay current on the changing GCP global regulatory environment and the impact on clinical compliance, quality, and operations
  4. Integrate a risk-based, resource-optimizing approach for effective selection, monitoring and long-term management of your clinical vendors and sites
  5. Position your trial for success by ensuring your clinical vendors and sites are inspection ready with the latest tools, technologies, and audit strategies

Who Should Attend

This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Quality Management/Clinical Quality Management
    • Clinical Quality Assurance/QA/CQA
    • Clinical Quality Control/QC/CQC
  • Clinical Operations/Management/Research/Development
  • Compliance/Clinical Compliance/Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Outsourcing/Vendor Management/Third-Party Management
  • Good Clinical Practice/GCP
  • Auditing
  • Clinical Risk/Risk Assessment
  • Regulatory Affairs
  • Medical Affairs

The event is also of interest to:

  • Investigative Sites
  • Academic Research Organizations
  • Central, Imaging and ECG Labs
  • IVRS Companies
  • EDC Companies
  • Other Clinical Service Providers


Agenda

Day One

Monday, 26 February

7:45 – 8:30
Registration Opens and Continental Breakfast for Workshop Participants

8:30 – 10:00
PRE-CONFERENCE WORKSHOP: ALIGNING TO ICH E6 R2
Identifying Critical Variables, Assessing Risk and Defining Control Measures for Aligning With ICH E6 R2

Keith Dorricott, Ambassador, METRICS CHAMPION CONSORTIUM (MCC)

10:00 – 10:30
30-Minute Networking and Refreshment Break

10:30 – 12:00
Workshop Resumes

12:00 – 13:00
Lunch for Workshop Participants/Registration Opens for Main Conference

13:00 – 13:30
CHAIRPERSON’S OPENING REMARKS AND GLOBAL UPDATE

David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE

13:30 – 14:15
SERVICE PROVIDER PREQUALIFICATION
Centralising Clinical Service Provider Qualification Activities to Drive Consistency, Efficiency and Higher Quality

Dennis Salotti, M.S., MBA, CCRA, Vice President, Operations, THE AVOCA GROUP

14:15 – 15:15
PANEL: CROSS-AGENCY INSPECTION COLLABORATION
Understanding Experiences With Joint Inspections and the Comparison of Inspection Data Across Agencies

Panellists
Susan Callery-D’Amico, Vice President, R&D Quality Assurance, ABBVIE
Heike Reinstaedtler, Director, Clinical Operations Quality, GSK VACCINES
Additional Panellists TBD

15:15 – 15:45
Networking and Refreshment Break

15:45 – 16:30
MHRA PERSPECTIVE: EVOLVING TECHNOLOGIES
Examining Electronic Systems in GCP and How to Remain Compliant in This Changing Environment

Gail Francis, Expert Inspector, Good Clinical Practice, MHRA

16:30 – 17:15
FDA INSPECTION READINESS
Understanding How the FDA Evaluates Practices and Procedures in Clinical Studies

Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC

17:15 – Close of Day One


Day Two

Tuesday, 27 February

7:45 – 8:45
Registration and Continental Breakfast for Conference Participants

8:45 – 9:00
CHAIRPERSON’S RECAP OF DAY ONE AND OPENING TO DAY TWO

David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE

9:00 – 9:45
TRIAL MASTER FILE (TMF)
Defining an Inspection-Ready Trial Master File and Knowing What to Expect During an Inspection

Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY

9:45 – 10:30
GSK CASE STUDY: QUALITY MANAGEMENT SYSTEM
Examining Oversight Expectations of the Quality Management System and Outlining Changes in Response to ICH E6 R2

Heike Reinstaedtler, Director, Clinical Operations Quality, GSK VACCINES

10:30 – 11:00
Networking and Refreshment Break

11:00 – 11:45
PFIZER CASE STUDY: QMS VENDOR ASSESSMENT
Leveraging a Quality Management System (QMS) to Qualify and Assess New Vendors for Study Engagement

Martin Thorley, Director, Vendor Quality Lead, PFIZER

11:45 – 12:45
PANEL: DATA QUALITY OPTIMISATION
Examining Effective Strategies for Ensuring Data Integrity When Executing Risk-Based Management and Oversight Approaches

Panellists
Keith Dorricott, Ambassador, METRICS CHAMPION CONSORTIUM (MCC)
Siobhan Hurley, Clinical QA Programme Manager R&D, Quality Assurance, ABBVIE
Additional Panellists TBD

12:45 – 13:45
Lunch

13:45 – 14:30
BAYER CASE STUDY: CLINICAL CAPAs
Establishing an Effective System to Initiate, Develop and Implement CAPAs, and Monitor and Track Their Status

Pearl Boakye, Ph.D., Head Compliance Management, BAYER

14:30 – 15:30
PANEL: ICH E6 R2 COMPLIANCE
Reflecting on the Actions and Process Adjustments Taken to Achieve ICH E6 R2 Compliance

Panellists
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC
Karen Hue, FRQA, Associate Director, Quality Assurance GCP, AIMMUNE THERAPEUTICS
Michele Weitz, Director, GCP Compliance Operations, CLOVIS ONCOLOGY

15:30 – 15:45
CHAIRPERSON’S CONCLUDING REMARKS

David Fryrear, Senior Director, Research and Development Quality Assurance, ABBVIE

15:45 – Conference Concludes




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Faculty

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Pearl Boakye, Ph.D.

Head, Compliance Management, BAYER

Pearl Boakye, Head, Compliance Management, BAYER HEALTHCARE


Susan Callery-D’Amico
Vice President, R&D Quality Assurance, ABBVIE



Keith Dorricott
Ambassador, METRICS CHAMPION CONSORTIUM (MCC)



Gail Francis
Expert Inspector, Good Clinical Practice, MHRA








David Fryrear
Senior Director, Research and Development Quality Assurance, ABBVIE

David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE








Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP
Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC








Karen Hue, FRQA
Quality Assurance Manager, GCP, EU, INTERCEPT PHARMACEUTICALS






Siobhan Hurley
Clinical QA Programme Manager R&D, Quality Assurance, ABBVIE









Heike Reinstaedtler
Director, Clinical Operations Quality, GSK VACCINES








Dennis Salotti, M.S., MBA, CCRA
Vice President, Operations, THE AVOCA GROUP









Martin Thorley
Director, Vendor Quality Lead, PFIZER







Michele Weitz
Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.









Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

Radisson Blu Portman Hotel

22 Portman Square

Marylebone

London

UK W1H 7BG

United Kingdom

View Map

Refund Policy

No Refunds

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