Abstract 

The Need for a New Approach to Quality Systems in Global Clinical and Regulatory Affairs for an International Biomedical Organization

Successful clinical trials are the lifeblood of a biotechnology organization that are at risk stemming from demanding expectations, ever changing requirements, being compounded across expanding global operations and a broad range of regulations. Managers and staffs need to focus on implementing quality systems that make it possible for the effective planning, coordination, collaboration, and oversight of these business-critical activities to conduct clinical research. As companies continue to expand their clinical operations to locations across the globe, staffs, cultures, and languages, the completion of these studies have grown to become the longest and most costly phase in the product development process. A new approach for quality processes are presented that goes beyond the typical study/trial-centric design widely used today to a system design approach that prevents the costly and time consuming operational quality problems caused by a lack of effective, risk-based oversight and control.

About Our Speaker 

Bob Parson is Vice President of Global Clinical & Regulatory Affairs for Inverness Medical Innovations. He has 34+ years of professional experience in pharmaceutical, and biotechnology. He is the function leader for the Sites of Clinical Excellence (SCE's) where global staffs plan, execute, monitor, analyze and report results from clinical studies (research, pre-clinical, post market) for in vitro medical diagnostics devices.(IVD"s) used in cardiology, oncology, infectious disease, drugs of abuse and women's health. 

He leads a network of the global regulatory affairs professionals who are responsible for regulatory submissions (510k, PMA, deNovo FDA clearance), CE Mark, worldwide registrations. Regulatory oversights across the corporation to insure compliance to global regulations are followed. He was Sr. Director of Biostatistics and Clinical Data Management at Biosite, Inc. Bob was responsible for the statistical planning, analysis and reporting in over 300 successfully cleared 510k, PMA and global submissions during his 16 years tenure as Director of Biostatistics for Hybritech Incorporated and Senior Staff Biostatistician for Beckman Coulter, Inc. He was the biostatistician for the first IVD test (PSA) cleared by the FDA for the detection of cancer (prostate). 

Bob has co-authored over 50 publications on immunoassays and diagnostics. He holds a BS in Biochemistry from Purdue University, MS in Applied Math and Statistics from Rochester Institute of Technology and a Masters of Advanced Studies (MAS) in the Leadership and Management of Healthcare Organizations from the University of California, San Diego. He is a Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), and Certified Healthcare Executive (CHE). 

He is a member of the American Statistical Association, American Heart Association, and American Society for Quality, American Association for Chemical Chemistry, Drug Information Association, and International Society for Pharmacoeconomics and Outcomes Research, Society for Clinical Trials, Society for Medical Decision Making, and Regulatory Affairs Professional Society. 

Inverness Medical Innovations, Inc. (NYSE: IMA) is at the forefront of the convergence between medical diagnostic testing and health management. IMA is a major global developer, manufacturer and marketer of advanced, pioneering professional and consumer medical diagnostic products, as well as a leader in specialized health management services including wellness, disease management, oncology and women and children's health. In its role as a leading supplier of consumer pregnancy, fertility/ovulation tests and rapid point-of-care diagnostics, IMA is committed to advancing health through a continuing flow of innovative new products brought about by our strong investment in R&D and intellectual property. Our latest areas of focus in diagnostics are the application of patented technologies to our consumer and professional diagnostics products, principally to the fields of infectious disease, cardiology, oncology, drugs of abuse and women's health. Our health management programs provide interventions designed to cover the entire lifespan from pre-cradle (maternity programs) to end-of-life care (complex care programs). This continuum of services addresses the healthcare needs of health plan and employer populations, while at the same time enabling healthcare providers to improve clinical outcomes and lower costs. IMA also manufactures and markets a wide variety of vitamins and nutritional supplements. With major research & development and operational centers in the US, UK, Germany and Israel, and manufacturing sites in the UK, China, Japan and the US, IMA is truly global in scope. Inverness Medical Innovations brings together the most complete form of care with the convergence of advances in medical diagnostics and personal health support. 

Pre-Clinic (30 minutes = 0.15 RU's)

This month for our pre-clinic, Kim Niles (ASQ Officer & Fellow, MSQA, CSQE, CQE) will cover part 3 of his pre-clinic series on "How to Succeed in Quality".  Nominal group techniques (NGT) will be used in related group exercises during this pre-clinic.  This month we will review the results of our June NGT brainstorm session and then discuss another related model and brainstorm another question using NGT.  So, what does it take to be successful in Quality?  Kim suggests we need to:

1. Have a Justified Position

   • Related Model = The Job Justification Triad:   You may be the most qualified person for the job and still lose it or fail to get hired for it due to any one of these three major justification types.  Every position has a different mix of these three justification types and that mix is continuously changing.

2. Be the Right Fit for That Position 

   • Related Model = The Candidate Selection Pugh Matrix Pentagon:  Five metrics commonly used to facilitate judging your fit in the organization.  

3. Meet Everyone's General Expectations.  We covered model #1 during our May meeting and brainstormed "What does it take to be successful in Quality?"

   • Related Model #1 = The XEAM Model:  Ways of looking at the various types of needs others have of you at work or home.  Those above you, below you, and beside you all have different expectations of you.

   • Related Model #2 = The Company Needs Model:  Ways of determining specific tasks that should be performed in order to meet performance expectations

4. Break Barriers in the Way of Progress.  We covered model #1 during our June meeting then brainstormed "What Barriers Do We Face as Quality Professionals?"

   • Related Model #1 = The AAMO Barrier Breaking Model:  Ways of determining the root cause of human situation related barriers in order to break through them.

   • Related Model #2 = Conflict Types and Resolutions Model:  Ways of identifying and resolving human, physical, and technical conflict 

5. Continuously Improve in order to Stay Competitive

   • Related Model #1 = The Quality Professional Roles & Strengths Model:  While various psychological tests exist for how we all think (4 - 34 different types of thinking depending upon the test), some ways of thinking have shown to benefit quality professionals better than others due to the types of roles we play.  This model attempts to model those connections

   • Related Model#2 = ASQ's new QBOK Model:  Methods for personal improvement

6. Become Recognized or "Branded" for Our Accomplishments

   • Related Model #1 = The Hierarchy of Needs and Motivations Model:  A derivation of Maslow's Model meant to promote discussion around personal needs and motivations.

   • Related Model #2 = E&E Communication Model:  Methods for selecting the most Efficient and Effective types of communication, to promote understanding, motivation, and recognition.

   • Related Model #3 = Recognition Types Model:  An overview of recognition types and importance.

Meeting details are as follows:

Meeting Details
RSVP	Please use the RSVP form below.
Meeting Date	Tuesday August 11, 2009 (normally the 2nd Tuesday of the month)
Agenda	5:15 pm             Registration & Happy Hour Begins 5:40 pm             Pre-meeting-clinic 6:10 pm             Dinner  6:35 pm             Announcements  6:45 pm             Main program   7:45 pm             Raffle and Speaker Prizes 7:55 pm             Adjourn
Menu	Buffet ... to be determined
Price RSVP Form Here
	NEW sponsor subsidized prices	No Food Arrive Late	Early RSVP	Dinner With RSVP	Dinner Without RSVP
	ASQ Student Members	Free	$5	$10	$12
	Regular Members	Free	$15	$20	$22
	Non-Members	Free	$20	$24	$26
Door Prizes	Door prizes issued at the end of every meeting
Dress	Nice Casual
Location	This month we're at: Country Inn & Suites By Carlson (formerly Prime Hotel, formerly Wyndham San Diego North) 5975 Lusk Boulevard, San Diego CA 92121 Their Phone: (858) 558-1818 see map here
Parking	Ample free parking
RU Points	0.15 pre-clinic meeting (30min) + 0.3 meeting (60min) = 0.45
Other Meeting Support	Announcing the Speakers: You ...or an officer at large Master of Ceremony:  Brett Carter Manning the Sign-in Table:  Officer Joel Davey Announcing the Prizes:  Officer Arta Motadel Ordering the Food:  Manijeh Farrokhi Coordinating the Speakers:  Abe Wong