Food and Drug Administration/Xavier University Global Medical Device Conference

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Federal Register: March 29, 2010 (Volume 75, Number 59)

Notices

Page 15439-15440

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr29mr10-68

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2010-N-0001

Food and Drug Administration/Xavier University Global Medical

Device Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device

Conference.'' This 3-day public conference includes presentations from key FDA officials, global regulators, and industry experts. The public conference has three separate tracks of interest for quality, regulatory affairs, and clinical research professionals, and is intended for companies of all sizes and employees at all levels.

Dates and Times: The public conference will be held on May 5, 2010, from 8 a.m. to 5 p.m.; May 6, 2010, from 8 a.m. to 5 p.m.; and May 7, 2010, from 8 a.m. to 1 p.m.

Location: The public conference will be held on the campus of

Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396.

Contact Persons:

For information regarding this notice: Gina Brackett, Food and Drug

Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, ext 167, FAX: 513-679-272, e-mail: gina.brackett@fda.hhs.gov.

For information regarding the conference and registration: Marla

Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: phillipsm4@xavier.edu.

Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, dinners, and dinner speakers for the 3 days of the conference. Early registration ends

April 5, 2010. Standard registration ends May 4, 2010. There will be onsite registration. The cost of registration is as follows:

Table 1.--Registration Fees\1\

Attendee

Fee by April 5th

Fee by May 4th

Industry

$995

$1,200

Small Business (Global compliance,

Global approval process,

Global harmonization,

Recalls and corrections and removals,

Common 483 observations,

What happens after an inspection,

Medical device reports,

Regulatory impact of design and process changes,

Integrating internal and external resources for clinical trials,

New ways of doing biostatistics,

Innovative clinical study design,

Challenges in conducting global clinical trials,

Comparison of design history file and dechnical dossier,

Integrating risk management in device/combination products,

Design controls: Human factors,

Labeling and promotion,

Corrective and preventive actions,

International filing requirements,

Promotion of device prior to approval,

Combination product filings--tips for successful application,

The role of information technology in clinical trials and post-approval process,

Bioresearch monitoring early intervention initiatives for electronic records, and

Handling images and other non-traditional electronic data.

FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the

Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) by providing outreach activities by Government agencies to small businesses.

Dated: March 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2010-6865 Filed 3-26-10; 8:45 am

BILLING CODE 4160-01-S

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