Food and Drug Administration (FDA), the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), Cardiovascular Angiography and measures (SCAI) and the national institutes of Health (NIH), with the support of the Society is announcing public Workshop on the development of Clinical pediatric heart devices.
Rarely is the equipment developed, evaluated and congenital heart disease, in particular, approved for the treatment of children. Small, heterogeneous population, long-term follow-up is needed because the market incentive and regulatory requirements and the cost-benefit analysis misperceptions are some problems that make trial of the standard control at random from the pediatric Cardiology difficult to implement. The workshop is intended to request information from the clinical, academia, professional associations, other government agencies and industry is one of the best ways to provide an efficient and practical presentation of clinical trial, which will contribute to the development of pediatric Cardiology equipment to overcoming patient population challenges.The data collected in This and future workshops help develop optimal aiheuttavalle pediatric Cardiology device testing instructions. Heart devices specially designed and/or pediatric patients, with the indication of the marketing approval would have a serious impact on public health.
Experts invited deals with a particular focus on models and statistical methods of analysis for the trial version of the clinical trials in the type (s) and clinical information that will help you in this population of patients, in particular, the challenges of alternative sources of supply. each section after the question and answer session is an audience and panel discussion will allow participants to interact with the workshop speakers and panelists. conclusions session allows other interactions.
This meeting will be held September 30 th, 2010, 8: 00 a.m., at the following location:
Romance Center, room 102
747 Howard Street
San Francisco, CA 94103,
The meeting is not videotaped or webcasted.
TimePresentation TitleSpeakerAffiliationChief Pediatrics medical officerCenter for devices and radiological (CDRH)
The u.s. Food & Drug Administration (FDA) Overview of pediatric device regulatory issuesBiomedical engineer, scientific reviewer
DIVISION of cardiovascular equipment (DCD)
CDRH
Funding support available through the NIH pediatric Cardiologist FDATypes developmentPediatric device
Funding/support through the FDA/for pediatric device OOPD developmentMedical officer NIH-NHLBI-Pediatric Heart NetworkTypes
Office orphan products Development (OOPD)
FDAChief,
Interventional Cardiology devices Branch (ICDB)
CDRH
Preclinical data planning, clinical trialsChief FDARole
Circulatory support and Prosthetics Branch (CSPB),
CDRH
FDAWhen is the appropriate vs. Control vs. performance goal at random from the clinical trial?medical officer,
DCD, ICDB
CDRH
FDAHow can can be done in pediatric Cardiology RCT?Pediatric Cardiology
Children's Hospital BostonWhat settings exist surgical difficulties to meet the randomizing controls?a member of staff
DCD
CDRH
FDAREPEL-CV-adhesion barrier trialConsider simultaneous randomized surgically controlsPediatric Cardiology
Cleveland ClinicEstablishing performance GoalsPediatric Cardiology
Rush University Medical CenterPediatric Cardiology
Johns HopkinsPanelists: Robert Beekman, m. (Administrator), Pamela Simons (AGA) and above, as well as various speakersBenefits and disadvantages of each Clinical Trial DesignsDivision and biometrics, Office of surveillance and biometrics (OSB),
CDRH,
FDABayesian and a small "n" trial designsDirector,
Biometrics, OSB, Division of
CDRH,
FDATips and tips to increase the size of a small "n" trialsPanelists information: Greg Campbell (Administrator) and Pediatric Heart network speakersLessons Learned single Ventricle reconstruction TrialLessons process Investigator-run TrialsJohns Hopkins children CenterDirector, HUD devices from
OOPD
FDAPanelists: Bram Zuckerman, m. (Administrator), Lynn Mahony, m. (UT West) and Epidemiology, above speakersDivision
OSB,
CDRH,
Impact of the Improved FDAThe register: Pediatric and adult congenital Cardiology, TreatmentsPediatric
Children's National Medical Center;
Chair, effects of steering CommitteeThe challenge records, historical and pediatric Cardiology Mayo ClinicPanelists trialPediatric device present: Charlie Berul, m. (Administrator), Thomas Jones, m. (Seattle Children); Pam Simons (AGA Medical), Fred Tobia (NMT Medical) Tim Rynn (W.L. Gore), and speakers
If you wish to participate in this Workshop, you must register at the close of business day, the 16th.September 2010.
There is no fee to register for the Workshop and registration is first come, first served basis. Early registration is recommended because seating is limited.
Public comments allowed and promoted at a meeting of the open comment during the discussion sessions.
If you need to be paid to the special Accommodations Enable disabilidád Lynn Colegrove, AAP, at 847-434-7820. If you need more information about registration, please contact Francesca Joseph, m., orphans Office Products Development, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32 Silver Spring, MD 20993, 301-796-6805, FAX: 301-847-8621, francesca.joseph@fda.hhs.gov.
Is in the hotel rooms block (Sept 29) on Wednesday and Thursday (Sept 30) can be called AAP housing 800 468-6322 (U.S./Canada); (415) 979-2290 (International) or call the Hotels directly (Hotels list: https://www.cmrhousing.com/aap_2n/hotellist.aspx)
.For more information about this meeting of the contact:
Francesca Joseph
Food and drug administration
Office orphan products Development
10903 New Hampshire Avenue, Bldg. 32 5277, Rm.
Silver Spring, MD 20993
Phone: 301-796-6805
Email: francesca.joseph@fda.hhs.gov
