505(b)(2) Submissions: Eligibility, Strategies & Preparation

is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, November 16th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.

In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.

How to Avoid GCP Non-Compliance Issues in Your Clinical Trials

is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, June 22nd, 2010. For more details or to register please visit our site at www.fxconferences.com

Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.

In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.

505(b)(2) Submissions: Eligibility, Strategies & Preparation

There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.

In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.

505(b)(2) Submissions: Eligibility, Strategies & Preparation is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, October 27, 2009. For more details, or to register please visit our site at www.fxconferences.com