'Substantial equivalence' presentation slideshows

Journal of Hypertension 2 0 09

Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document . Journal of Hypertension 2 0 09. Authors/Task Force Members:

815 views • 65 slides

Roy Baby, Investigator US Food & Drug Administration 4040 N Central Expressway, Dallas, TX

The 510(k) Program. Roy Baby, Investigator US Food & Drug Administration 4040 N Central Expressway, Dallas, TX. A Premarket Notification [510(k)] is one of the major pathways for bringing a device to market. Presentation Outline. Device Classification As It Relates to 510(k)s

543 views • 54 slides

Development of concepts WHO, Comparative assessment Unintended effects, SAFOTEST Allergenicity

Development of concepts WHO, Comparative assessment Unintended effects, SAFOTEST Allergenicity HGT, GMOBILITY Risks from the environment ? Conclusions Alexander Haslberger 7/04. Breeding: Irradiation.

543 views • 49 slides

Medical Device Clinical Studies and Protocol Design IVT Medical Device Conference San Francisco

665 views • 43 slides

Regulatory Science

575 views • 42 slides

The GMO Show!

The GMO Show!. The GMO Show!. Identify the false statement in each set of Facts. The first word of each FALSE statement will be used to spell out a topic of the day. The GMO Show!. Each of the following are GE products EXCEPT FlavrSavr Tomatoes Bt Corn for insect resistance

451 views • 34 slides

Scientific Panel on Genetically Modified Organisms (GMO Panel)

Scientific Panel on Genetically Modified Organisms (GMO Panel). Harry A. Kuiper Presentation to the EFSA Management Board 11 September 2007, Bucharest. Topics on the GMO Panel . Areas of work and Accomplishments

731 views • 31 slides

RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003

Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Food and Drug Administration. RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003. Outline. Who we are

480 views • 27 slides

359 views • 24 slides

Classification of HLA Devices FDA Introduction & Background

Classification of HLA Devices FDA Introduction & Background . Sheryl A. Kochman CBER/OBRR/DBA. Objectives. Provide an overview of the current regulatory status of HLA devices Provide background regarding medical device classification Provide an overview of the Third Party Review Program.

603 views • 23 slides

Testing Your Device: What the FDA Looks For

Testing Your Device: What the FDA Looks For. Bio. Vice President, Regulatory and Clinical Affairs Graduated Tulane University in Biomedical Engineering; MS in Bioengineering Clemson Develop comprehensive regulatory strategies for complex musculoskeletal devices and biologics

352 views • 13 slides

IQAB Mutual Recognition Agreements (MRAs ) Determining Substantial Equivalency

IQAB Mutual Recognition Agreements (MRAs ) Determining Substantial Equivalency. Presented to the IAAER Midyear Meeting American Accounting Association February 21, 2014. Ruben Davila, CPA, Esq. Former Member, U.S. International Qualifications Appraisal Board

258 views • 12 slides

IQAB Mutual Recognition Agreements (MRAs ) Determining Substantial Equivalency

IQAB Mutual Recognition Agreements (MRAs ) Determining Substantial Equivalency. Presented to the IAAER Midyear Meeting American Accounting Association February 21, 2014. Ruben Davila, CPA, Esq. Former Member, U.S. International Qualifications Appraisal Board

275 views • 12 slides