Clinical Trial Risk Management Seminar

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


San Francisco (Burlingame), CA, United States

We extend our 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.

Top Five Reasons To Attend

  1. Having successfully established a series of clinical quality events on the East Coast and in Europe, we bring our well-known conference series to San Francisco with a Clinical Trial Risk Management Seminar geared towards biotechnology and biopharmaceutical companies.
  2. Understand the implications of ICH E6 R2 and how your clinical risk management practices must evolve to be compliant.
  3. Ensure your clinical quality risk management plan covers all the critical elements to ensure GCP compliance.
  4. Develop an effective strategy to work with and oversee your CRO partners to ensure transparency, compliance, and productivity.
  5. Learn the tools to achieve a constant state of inspection readiness.

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

Speakers

  • Matthew Burtt, Director, Clinical QA, ABBVIE
  • Pam Dellea-Giltner, B.D., MBA, CCRA, President, PDG CLINICAL CONSULTING, LLC
  • Jason Donnelly, Director, Clinical Quality and Compliance, SCHOLAR ROCK, LLC
  • Sheila Gwizdak, Principal Consultant , HALLORAN CONSULTING GROUP
  • Todd Johnson, Principal Consultant, HALLORAN CONSULTING GROUP
  • Rhonda Pisk, M.S., ACRP-CP, ACRP-PM, Clinical Program Director, STANFORD UNIVERSITY SCHOOL OF MEDICINE
  • Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY, INC.
  • Liz Wool, President, WOOL CONSULTING GROUP, INC.

Venue

Hyatt Regency San Francisco Airport
1333 Bayshore Highway
Burlingame, CA 94010

The newly-renovated Hyatt Regency San Francisco Airport is conveniently located in Burlingame, situated between downtown San Francisco and near many Silicon Valley industries. Designed for the business and leisure traveler, our San Francisco Airport hotel is the perfect starting point for vacationers to explore the Bay Area or executives on the go.