2009 CBER Foreign Regulators Seminar

2009 CBER Foreign Regulators Seminar
October 5-9, 2009
Rockville, Maryland

Introduction

The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research presents its second annual CBER Foreign Regulators Seminar to foreign regulatory counterparts interested in learning about our biologics review process. This training is open only to staff from foreign pharmaceutical regulatory (government) authorities at the request of their organizations. This training is not intended for U.S. government employees.

CBER is privileged to offer a regulatory seminar in response to international requests for information and training.

The CBER Foreign Regulators Seminar will provide information about the U.S. biologics regulatory process, which includes vaccines, blood and blood products, cellular and gene therapies, human tissues, medical devices, biostatistics and epidemiology, compliance and biologics quality, reviewer training guidance and regulations, bioresearch monitoring, licensing and post-marketing activities.

There is no registration fee for this program; however, attendees are responsible for their own travel, lodging and food expenses. The program will be offered in Rockville, Maryland.

Agenda

Registration Information

If a pharmaceutical regulatory authority is interested in having its staff participate in the seminar, a senior official of the regulatory authority should send information listed below via email to CBERForReg@fda.hhs.gov for each potential participant. As a reminder, the CBER Seminar is intended for international pharmaceutical regulatory authorities and only registration from pharmaceutical regulatory authorities will be honored. Please include the following information about the proposed attendee:

Name
Position
Title
Country
Name of Regulatory Authority
Address
Phone
E-mail
An Invitation letter will be sent to applicable requesting participants. Registration is confirmed upon receipt of a “Confirmation” letter from the CBER Foreign Regulators Seminar.

A full Agenda will be posted prior to the seminar.

For Further Information, Contact:

Joan Wilmarth Blair, M.A.
International Affairs Advisor
Office of the Director
Center for Biologics Evaluation and Research
United States Food and Drug Administration
U.S. Department of Health and Human Services
CBERForReg@fda.hhs.gov

Also note the Center for Drug Evaluation and Research (CDER) will host the CDER Forum for International Drug Regulatory Authorities.

abrir aquí para acceder al documento FDA:
2009 CBER Foreign Regulators Seminar