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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
September 20, 2011 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This course is intended for professionals within the pharmaceutical and biopharmaceutical industries. It will be especially beneficial for:
• Document Managers
• Regulatory Affairs Personnel
• Managers and Directors of Regulatory Submissions
• Those Involved in Clinical Trials Description
Orphan Drugs, designed to treat or prevent diseases affecting fewer than 200,000 persons, have a special FDA status. Fees are waived; exclusivity protection is provided and there is some additional flexibility in experimentation and approval. Orphan Drug Status is awarded after agency review of a submitted Orphan Drug Application.
This 90-minute accredited online training provides guidance on the FDA evaluation criteria and a submissions checklists. Discussions will include the current FDA Orphan Drug Program; steps involved in the application process and key issues to be considered. This training includes a means for assessment.
Recommended Reading: The Course Director recommends, as optional reading, the text Handbook of Drug Regulatory Submissions– (Wiley).
Review of Learning Objectives
Module 1: The FDA Orphan Drug Program:
• Rationale for orphan program
• Successes and failures
• Orphan Drug Grants
Module 2: The Orphan Drug Application:
• Components and Requirements
• The Application Process
• Key Issues: Disease Frequency, Drug Efficacy
Module 3: The Orphan Drug Submission:
• Components and Requirements
• The Application Process
• Key Issues-Frequency Data
• Outlook of the Program
Question and Answer Session
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Dr. Sandy Weinberg, Associate Professor of Healthcare Management, Clayton State University
Dr. Sandy Weinberg, with 25+ years of FDA regulatory experience, is a professor of Health Care Management at the School for Professional Studies of Clayton State University, part of the Georgia State University System. He is teaching and researching Regulation and Biodefense. He has been a leader in the field of system validation for more than twenty years and a practitioner in regulatory submissions, auditing, international liaison, and biodefense vaccine development. He has consulted to the FDA, most other regulatory agencies worldwide, and the industry. Dr. Weinberg is the author of numerous books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, Good Laboratory Practice Regulations, and The Handbook of Drug Regulatory Submissions. His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.
Dr. Weinberg is a member of the Board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands. Recently retired, Dr. Weinberg was Senior Director for Biodefense at GE Healthcare and Vice President of Tikvah Therapeutics; as well as an investor in and Board member of several international biomedical companies.
Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas. Recent projects include the auditing and certification of a chromatography control system; a business development and fund raising project for a biodefense vaccine company; an Orphan Drug submission; and the validation of a Laboratory Information Management System. Much of Dr. Weinberg's practice is centered in the US, Western Europe and Israel.
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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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sberg@cfpa.com
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