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Clinical Trial Risk Management Seminar - Hyatt Regency San Francisco Airport

Clinical Trial Risk Management Seminar
May 21 - 22, 2019
Hyatt Regency San Francisco Airport
San Francisco, CA

Identify, Assess and Manage Clinical Risk to Ensure Compliance and Achieve Inspection-Readiness

Clinical Trial Risk Management Seminar – Clinical Trial Risk Management Seminar

ExL extends its well-known and established clinical quality series of events to the West Coast. Responding to the many requests by our loyal audience, we have developed a Clinical Trial Risk Management Seminar, featuring two days of interactive sessions and panels. This seminar provides a comprehensive education on clinical risk management and the tools to assess, maintain and mitigate risk to ensure compliance. Join us on May 21–22 in San Francisco for this exciting gathering of clinical quality, compliance and operations executives from the leading biopharma companies, service providers and sites.

THE IMPACT OF ICH E6 R2

Breakdown the Critical Elements of ICH E6 R2 and Their Impact on Clinical Operations

Pam Dellea-Giltner, B.S., MBA, CCRA,
President,
PDG CLINICAL CONSULTING, LLC
Julia Moore,
Associate Director, Clinical Operations,
SANGAMO THERAPEUTICS, INC.

CRO OVERSIGHT

Build an Effective CRO Oversight Plan That Is Compliant With ICH E6 R2


Liz Wool,
President,
WOOL CONSULTING GROUP, INC

MANAGE CLINICAL RISK

Develop an Achievable Clinical Risk Management Process With Limited Resources

Todd Johnson,
Principal Consultant, Organizational Solutions,
HALLORAN CONSULTING GROUP
Sheila Gwizdak,
Principal Consultant, Quality,
HALLORAN CONSULTING GROUP

CLINICAL INSPECTION READINESS

Create a Preparation Plan That Guides All Stakeholders to Achieve a Constant and Confident State of Inspection Readiness


Michele Weitz,
Senior Director, GCP Compliance Operations,
CLOVIS ONCOLOGY
Startdate:
End Date

Description:
Performer:
Address : Clinical Trial Risk Management Seminar


Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical trial service providers whose responsibilities involve the following:

  • Good Clinical Practice (GCP)
  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research
  • Quality Management/Global Quality Management
  • Audits/Inspections
  • Compliance/Global Compliance
  • Data Management/Systems Operations
  • Clinical Monitoring
  • Regulatory Affairs
  • Safety and Risk Management/Operations

This event is also relevant to clinical QA, compliance and operations professionals from:

  • Quality Service Providers and Consulting Companies
  • CROs
  • Central, Imaging and ECG Labs
  • Investigative Sites
  • IRBs
  • Data Management and Software Vendors
  • Safety Reporting Vendors
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