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The Center for Professional Advancement, 90 Minute Accredited Online Training
March 10, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is designed for professionals within the pharmaceutical and biologics industries who are interested in the planning and submissions of INDs. The training will be especially valuable to
• Regulatory personnel
• QA Managers
• Directors, and VPs
• Representatives of Contract Research Organizations
(CROs)
Description
The FDA procedures for the clinical testing of drugs, potentially leading to the filing of an NDA or ANDA, are evolving rapidly. This 90-minute accredited program examines the steps involved in dealing with the FDA Pre-IND meeting and the procedures for electronic IND filing. Quality issues within the clinical arena will be addressed. Attention will be directed toward developing a plan for the pre-IND meeting and industry and FDA guidelines for electronic INDs.
Dealing with the FDA Pre-IND Meeting and Details of Electronic Filings
Module 1: Quality Issues in Clinical
• Clinical Team pre-IND meeting with FDA
• Focusing on the important issues and meta-issues
• Evaluating research facilities and strategies
• Ethical issues
• Protection of the safety, rights of persons participating
Module 2: Prep for the Pre-IND Meeting
• Early interactions with FDA staff to help to prevent clinical
issues from arising
• Selection of appropriate CROs and Investigators
• The Mock-Meeting: managing expectations
• Efficient use of FDA resources
Module 3: Electronic INDs
• Evolving process
• Industry guidance and FDA guidelines
• e-Forms
• Alternatives: paper, paper with electronic index, paper with
hyperlinks
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Carl A. Rockburne, Regulatory Consultant
Carl Rockburne is a regulatory consultant with extensive experience in the electronic IND (and other filings) systems. He has been involved in the field of system validation. Additionally, he was a full time consultant to GE Healthcare Fast Trak BioDefense program. A program designed to be a free standing entrepreneurial program within GE Healthcare.
Mr. Rockburne has also worked with small/ medium research & development companies in their search for vaccines for, including, small pox, avian influenza, Ebola, rift valley, botulinum. Mr. Rockburne is a Certified Regulatory Compliance Auditor to the biomedical industries. (Part 11; GMP; GLP; GCP etc. He is an expert on international clinical testing requirements, and has authored the international filings chapter for the Guidebook to Drug Regulatory Submissions,summarizing the requirements of Canada, Australia, Japan and the EMEA.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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