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Maria E. Donawa - M.D.--Regulations
Dr. Donawa is a former FDA official, now based in Rome, Italy. She is
President of Donawa & Associates Ltd. and is an expert in both European
and US regulations. Dr. Donawa may be reached at
donawa@srd.it.
Danielle Giroud - European CRO
Danielle Giroud started her career in the Medical Device Industry in
1987 as a Product Manager for vascular stents for Schneider, Europe. She
subsequently worked for Serono and Collagen Inc. Ms. Giroud is an active
member of the ISO 14155 'Clinical investigations for medical devices'
and 'clinical investigation plan' working group. In 1997, she founded
d-TARGET, a clinical research organization specializing in medical
device clinical trials in Europe. Her website is
www.d-target.com.
Paul W. Goebel - Consultant
Mr. Goebel is President and Founder of Paul W Goebel Consulting, Inc.,
an independent consulting firm in Monrovia, Maryland. Paul W Goebel
Consulting provides consulting, training and auditing services for IRBs,
clinical investigators and sponsors. The services are concentrated in
the areas of informed consent and protection of human subjects of
research. He can be reached at
paul@pwgconsult.com.
Erica Heath - Institutional Review Boards
Erica Heath is President and Founder of IRC - Independent Review
Consulting, Inc. at www.irb-irc.net .IRC was formed in 1984 to operate
an independent, central IRB. Prior to founding IRC, Ms. Heath worked for
14 years as IRB Administrator at the University of California, San
Francisco. She has a BA from San Jose State University and an MBA from
Golden Gate University. She is CIP certified and has been on several
editorial boards and councils and has lectured and taught at many
courses. She is married and has two teenagers.
Steve Schurr - Attorney at Law
Mr. Schurr is a health care attorney practicing in Chicago. He
previously worked in clinical research and regulatory affairs for
medical device companies. He may be reached at
SchurrHC@aol.com or at
www.steveschurr.com.
Michelle Secic - Statistician
Michelle Secic is president of Secic Statistical Consulting, Inc. Her
more than ten years' experience at the Cleveland Clinic Foundation gave
her opportunity to work on many types of clinical studies. Her focus on
good planning and data integrity facilitate the conduct of quality
clinical research. Ms. Secic may be reached at
www.secicstats.com.
Nancy J Stark - Forum Administrator
Nancy J Stark has worked in medical device clinical research since 1980.
In 1990, she founded Clinical Device Group, a consulting and contracting
firm for medical device pre-approval issues. In 2002, she established
the Clinical Device Discussion Forum, recognizing a need for a global
platform for discussing medical device issues. She can be reached at
www.clinicaldevice.com or
njstark@clinicaldevice.com.
Patsy J.Trisler, J.D., RAC - US Regulatory
Ms. Trisler, formerly with the FDA in the Center for Devices, has been
consulting with medical device companies since 1991. She provides FDA
submission assistance and advises on pre-clinical and clinical study
requirements, as well as labeling and post-approval compliance. Ms.
Trisler may be reached at
patsy.trisler@verizon.net.
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