is being presented by Donald Palmer, Associate Director, Regulatory Systems, with MedImmune and airs on Tuesday, November 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
As more companies work closely with partners, outsource partners, or CROs, the need to standardize processes and requirements for electronic submissions is becoming more pronounced. In addition, there is a need for these interactions to be efficient, from publishing processes and systems to document management, to the authoring process.
This audio conference presentation looks at the current types of processes and technology needed for electronic regulatory submissions, for companies both small and large. It also considers possible changes to these processes and technology, as a company grows and/or seeks to gain greater efficiencies. The speaker also looks at where tools might be developed and/or integrated for further efficiencies.
Thursday, October 7, 2010
Wednesday, October 6, 2010
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.
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.
Tuesday, October 5, 2010
Understanding QSR Acceptance Activities for Medical Devices
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, November 10th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA’s Quality System Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. This is one of the top five sections cited in FDA Warning Letters.
This audio conference explains the regulations and provides guidance on implementation. We analyze the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We also explain the guidance offered in FDA’s QSR Manual. This guidance helps manufacturers implement the regulations by clarifying the expectations and providing sample procedures and forms. This document is valuable, and even appears in an FDA Warning Letter as a recommendation to help a manufacturer come into full compliance.
The presentation includes an examination of some Warning Letters, reviews some mistakes that manufacturers have made, and looks at ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
The FDA’s Quality System Regulation (QSR) sets requirements for acceptance activities related to medical device manufacture. The requirements cover three acceptance areas: receiving, in process, and final. In addition, QSR has specific requirements for procedures and minimum requirements for record keeping. This is one of the top five sections cited in FDA Warning Letters.
This audio conference explains the regulations and provides guidance on implementation. We analyze the regulations and discuss the FDA’s intent as provided in the preamble to the regulations. We also explain the guidance offered in FDA’s QSR Manual. This guidance helps manufacturers implement the regulations by clarifying the expectations and providing sample procedures and forms. This document is valuable, and even appears in an FDA Warning Letter as a recommendation to help a manufacturer come into full compliance.
The presentation includes an examination of some Warning Letters, reviews some mistakes that manufacturers have made, and looks at ways to avoid them. We also see a few instances where a Warning Letter does not align with the guidance in the QSR Manual or the QSR preamble.
Monday, October 4, 2010
Effective Translation Process for Japan Regulatory Submissions
is being presented by Jason Heaton, Compliance Specialist, with ForeignExchange Translations, and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Many companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.
The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.
This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.
Many companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.
The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.
This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.
Friday, October 1, 2010
Putting an End to Workplace Bullying – Before It Becomes Law
is being presented by Jodie-Beth Galos, Esq., SPHR, Employment Law Attorney and airs on Tuesday, November 9th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Have you ever encountered a workplace bully – a manager, co-worker or someone you supervise? Most of us have -- and have the scars to prove it. Why do we allow this bad behavior to persist when we know it causes turnover, stress and dysfunctional teams, not to mention consuming hour upon hour of management time?
There are more than humanistic and management issues to consider. A number of states are entertaining legislation that would make workplace bullying unlawful – resulting in legal claims that could cost your organization huge amounts of money and untold amounts of bad press and public embarrassment. Plaintiffs’ lawyers rejoice when there’s a new reason to sue employers, forcing large settlements or winning enormous jury verdicts. In this timely audio conference, we consider the "No Jerks Rule" and how to bullet-proof your organization against workplace bullies and the associated fallout.
Have you ever encountered a workplace bully – a manager, co-worker or someone you supervise? Most of us have -- and have the scars to prove it. Why do we allow this bad behavior to persist when we know it causes turnover, stress and dysfunctional teams, not to mention consuming hour upon hour of management time?
There are more than humanistic and management issues to consider. A number of states are entertaining legislation that would make workplace bullying unlawful – resulting in legal claims that could cost your organization huge amounts of money and untold amounts of bad press and public embarrassment. Plaintiffs’ lawyers rejoice when there’s a new reason to sue employers, forcing large settlements or winning enormous jury verdicts. In this timely audio conference, we consider the "No Jerks Rule" and how to bullet-proof your organization against workplace bullies and the associated fallout.
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