miércoles, 28 de agosto de 2013

CDER Small Business Update: FDA Clinical Investigators Training Course and New Guidance for IRBs, Clinical Investigators and Sponsors

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

1. FDA Clinical Investigators Training Course
The Fifth Annual Clinical Investigator’s course, co-sponsored by the Food and Drug Administration’s office of Medical Policy and the Duke School of Medicine is now open for registration. The dates for the course are Nov 12-14, 2013. The venue is The Holiday Inn, College Park, MD 20740. The booking group code for your Clinical Investigation Training in November is “CTT”; individuals must call 301-345-6700 or email reservatioins@hicollegepark.com to book reservations.
This extensive three day course focuses on non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. The course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials.

For more information on the course, and to register for the course, click here.

You will need to create a profile prior to registering for this course. For instructions on how to set up a profile please see the instructions on the registration page.
The course fee is $400.00. Visa and Mastercard are accepted. CME credits are available.

2. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed

This guidance document is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators and adequacy of research sites, and determining whether an investigational new drug (IND) application or investigational device exemption (IDE) is required, to protect the rights and welfare of human subjects involved in biomedical research.

Federal Register Notice

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.