viernes, 31 de agosto de 2012

Last Minute Registration Details: FDA REdi Fall 2012 Conference/ Agenda Highlights

The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER's Small Business Assistance

The Food and Drug Administration (FDA) Small Business 
Regulatory Education for Industry (REdI) 
What: The REdI Conference Fall 2012 
When: September 19-20, 2012  
Where: Washington, DC

FDA Small Business invites you to our collaborative Conference between the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). Take advantage of this 2-day conference to network, engage with FDA experts, and learn more about FDA’s regulatory requirements for drugs and medical devices.

Highlights of CDER topics on the Agenda:

- Keynote address by Dr. Janet Woodcock.
- Meetings with FDA 
- Overview of Non-Clinical Safety Assessment in Drug Development 
- Imports and Exports - IND Considerations 
- Submitting an IND - What you need to know 
- Drug Registration and Listing: An Overview
- GMPs for Biotechnology Products
- Generic Drug User Fee Amendment (GDUFA) - User Fee Structure
- Postmarket Drug Safety Reporting and Pharmacovigilance Practice

The Agenda also includes two plenary sessions on:

- Regulatory Considerations for Personalized Medicine and Companion Diagnostics 
- Combination Products: an FDA Discussion on Regulating Combination Drugs, Devices, and Biologics

Advance registration is required. Registration is FREE and includes training materials only. Please find details at REdI Fall 2012.
The meeting will NOT be webcast or taped, and slides will NOT be posted on the FDA website. Flash drives and presentation files will not be available for mailing or emailing. You must be present to receive the materials flash drive.  Materials will be provided via flash drive upon conference check-in.

The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff.  If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM.
Please take our CDER Small Business survey:

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