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ComplianceOnline, OnlineEvent
2012-08-28
You will learn techniques for drafting and filing successful petitions including the required elements of such petitions and the types of substantiation needed to support them. Why Should You Attend: The webinar is intended to provide participants with strategies for drafting targeted and effective Citizen Petitions and Suitability Petitions for submission to FDA. Recommendations for strengthening petitions and increasing the chances of ultimate success will also be provided.
Attendees will learn techniques for drafting and filing successful petitions. The presenter will share info on where to find relevant FDA regulations and guidance documents; the required parts of a petition; the scientific evidence and data needed to support a request; and how to file such a petition. The types of requests generally and examples of specific requests will be covered. The instructor will also provide a legal analysis of recent approval trends to help participants identify the types of issues and petitions that are finding success at FDA.
The session will also highlight amendments to the Federal Food, Drug, and Cosmetic Act in 2007 intended to curb branded drug manufacturers from abusing the petition process for the purpose of delaying generic approvals. Because of those changes, FDA is no longer allowed to delay the approval of a pending ANDA unless a delay is necessary to protect the public health. Learning Objectives: Upon completion of the course you will: - Gain an understanding of FDA's regulation of Citizen Petitions and Suitability Petitions.
- Learn what is needed to file a petition including the required components and format; what can be requested of the Agency; and the types of scientific substantiation recommended for supporting a petition.
- Provide Regulatory and In-House Attorneys with an introduction to the FDA petition process to help them draft and file their own petitions.
- Learn strategies for drafting and filing successful Citizen Petitions and Suitability Petitions.
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Organized by:
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Complianceonline |
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Invited Speakers:
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Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He frequently assists clients with the development and execution of regulatory strategies for supporting the product life cycle and expediting the approval process via the use of Citizen Petitions and Suitability Petitions.
Professionally, as a member of Squire Sanders, Karl provides regulatory advice and counseling to domestic and international drug, biologic, medical device and biotech companies including manufacturers, specification setters, contract manufacturers, labelers, packagers and distributors. He advises these companies on issues related to the U.S. Food and Drug Administration’s regulation of the development, approval and promotion of drugs, biologics, medical devices and veterinary products. He frequently presents and has published on such topics.
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Deadline for Abstracts:
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2012-08-27
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Registration:
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| $349.00 | One Dial-in One Attendee |
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E-mail:
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referral@complianceonline.com
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