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2008
RISK MANAGEMENT SYMPOSIUM
May 29-30, Irvine, CA

About | Draft Agenda | Presenters | Registration Info | Hotel Info

Link to registration page: www.md-review.net/westcoastRM/registration.aspx

About:

In August 2002, the United States Food and Drug Administration (US FDA) announced a significant new initiative; a framework for the regulatory oversight of manufacturing processes based on quality systems and risk management approaches. Updated regulatory guidance and standards on risk management have been issued worldwide since then.

In March 2005, US FDA released the Premarketing Risk Assessment, Development and Use of Risk Minimization Action Plans, and the Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance. These documents aim to guide medical product companies to implement a comprehensive risk management system to fulfill the expectations of the new initiative.

Currently, Risk Management practices have been gaining momentum globally, spurred on by the final release of many ICH and EU Guidelines. Drug approvals now commonly require the implementation of Risk Management. Risk Management is demanding a higher level of proficiency. Competent authorities and notifying bodies are conducting Risk Management audits, some companies are implementing Risk Management systems, and a few universities are launching Risk Management education programs. More opportunities are available to individuals wishing to learn and use Risk Management.

The Risk Management Symposium, hosted by Virginia Tech’s Center for Applied Health Sciences, is intended to provide regulatory and industry perspectives on risk evaluation and management for health products, with a focus on drugs, devices, and combination products. Participants will work on group projects. We will cover the total life cycle approach to risk management, review available tools/approaches for risk assessment, modification/control and communication. We will discuss the design of a course in the area of Risk Management being offered to professionals in regulatory agencies and across the healthcare industries.

Symposium Objectives:

  1. To communicate the basics of a total lifecycle approach to risk management.

  2. To discuss the different types of risk related to manufacturing and clinical use of health products.

  3. To understand how to select the appropriate tools to assess various types of risks.

  4. To understand approaches for risk modification, mitigation, and control.

  5. To review continuing education options available for formal education in risk management

 Risk Management Symposium

Symposium co-sponsors:

  • Orange County Regulatory Affairs

  • American Society for Quality, Section 0713

  • Medical HACCP Alliance

    •

Sponsored by:
Virginia Tech

 CENTER FOR APPLIED
HEALTH SCIENCES
 www.cahs.vt.edu


DRAFT AGENDA

Thursday, May 29th

Key Note

  • FDA’s Approach/Experience in Risk Management Training
    (Alonza Cruse)

  • Applications of Risk Management for Health Products
    (George Flick)

Systems Approach

  • Total Life Cycle Risk Management
    (Tony Chan)

  • Major Elements of Total Life Cycle Risk Management
    (Mark Frankcom)

Risk Context

  • Hazard/Risk Identification
    (Tony Chan)
  • Case Study I: Hazard/Risk Identification
    (Anshu Vashishtha, Peter Simons)

Risk Assessment

  • Tool Illustration I with a Case Study (Mark Frankcom)

  • Design Space: Pharmaceuticals
    (    Anshu Vashishtha)

Risk Modification/Control

  • Tool Illustration II: Critical Limits
    (Joseph Salyer)

  • Case Study II: Orthopedic Implant (George Shen)

Group Project:

  • Hazard Identification & Tools to be Used
    (Tony Chan)

Panel Discussion

  • Q & A

Friday, May 30th

Risk Acceptance

  • How Safe is Safe Enough: Use of Standards (Mike Schmidt)

  • Risk/Benefit Analysis
    (Helene Spencer)

Risk Communication

  • Pharmacovigilance
    (Anshu Vashishtha)

  • Outsourcing
    (Andros Chan)

Group Project:

  • Risk Acceptance Policy
    (Mark Frankcom)

Risk Review, Effectiveness, and Efficiency

  • Case Study III: Corrective Action and Preventive Action
    (Jim Niederecker)

  • Case Study IV: Usability
    (Edmond Israelski)

  • Case Study V: Economics of Risk Management
    (TBA)

  • Case Study VI: Liability Protection
    (Brian Donato)

Group Project:

  • Review Effectiveness & Efficiency
    (Anshu Vashishtha)

Panel Discussion

  • Q & A / Wrap Up


*The Symposium sessions run from 8:00 am to 5:00 pm on both days.

PRESENTERS

Andros Chan
Managing Director
Pharos Med. Dev.

Tony Chan
Program Development Director Virginia Tech

Alonza Cruse
L.A. District Director
U.S. Food & Drug Administrator

Brian Donato
Partner
Hyman Phelps & McNamara

George Flick
University Distinguished Professor Virginia Tech

Mark Frankcom
Adjunct Professor Virginia Tech

Edmond Israelski
 Human Factors Program Manager
Abbott Laboratories

Jim Niederecker
Advisor
Abbott Vascular

Joseph Salyer
Compliance Office
CDRH, U.S. FDA

Mike Schmidt
 Instructor  
 Virginia Tech

George Shen
L.A. Region Sales
Stryker Orthopedic

Peter A Simons Ph.D.
Clinical Research Scientist
Consumer Eye Care R&D
Allergan LLC

Helene Spencer
V.P. of RA
Glumetrics

Anshu Vashishtha
Adjunct Professor
Virginia Tech


REGISTRATION

2008 Risk Management Symposium 
May 29-30, 2008 
FDA L.A. District Office 
19701 Fairchild Avenue 
Irvine, CA 92612 
Registration will include lunch on both days, refreshment breaks, and all conference materials. 
Space is limited -- please register early. 
$795 - Individual registration received after May 3rd. 
$695 - Members of OCRA or ASQ0713 
$650 - Groups of five or more, registered with a single payment by May 3rd. 
$295 - Government & Academia 

The deadline to register is May 23, 2008.
Visit the Registration Page. 



Hotel Information
Attendees can reserve lodging at either of these nearby hotels:
Marriot Suites - Newport Beach
500 Bay View Circle
Irvine, CA 92660
(949) 854-4500
Map & Directions
 Hyatt Hotel - Newport Beach
1107 Jamboree Blvd
Irvine, CA 92660
(949) 729-1234
Map & Directions


Contacts

For more information on the Symposium or to register by fax or mail, please contact:

Angela Correa
Virginia Tech
540.231.2075
acorrea@vt.edu

For travel and lodging questions, please contact:

Linda Hartley
FDA L.A. District Office
949.608.4413
Linda.Hartley@fda.hhs.gov


Copyright ©2008 Center for Applied Health Sciences, Virginia Tech.

Virginia Tech