When a 510(k) or PMA Goes Off Track - FDA's Appeals Process

is being presented by Jeffrey K. Shapiro, JD, Director, with Hyman, Phelps & McNamara, PC and airs on Tuesday, June 21st, 2011. For more details, or to register please visit our site at www.fxconferences.com

It goes without saying that the ability to successfully obtain FDA approval is critical to the success of a medical device and, by extension, a medical device company. However, sometimes even the most dedicated of efforts fall flat when FDA says "No." What then? What can you do if FDA says it believes there is not an adequate predicate device for your product? Or if FDA is requiring an overly burdensome clinical study? Or imposing data requirements that were not applied to your competitor's similar 510(k) six months earlier?

This presentation covers the appeals processes that are available to medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. Our speaker draws upon years of experience to provide practical tips and advice on how to resolve a dispute with FDA so that your 510(k) or PMA can move forward to clearance or approval. The presentation looks at the best approach to take, and what to expect in terms of the length of the appeals process, and the likelihood of success.

Choosing and Managing Contract Medical Writers

is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Thursday, July 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Contract writers, whether freelancers or CRO personnel, can be an important extension of medical writing resources during planned workload peaks or when unexpected writing projects arise.

This audio conference presentation is designed to provide sponsors with information on how to get the best product from a contract writer, and to show contractors how to ensure they produce materials that meet sponsors’ expectations.

Our speaker provides attendees with practical recommendations and case studies of successful collaborations, and emphasizes the process of report writing – including preparation of a shell report prior to availability of final data displays, and other activities that can maximize sponsor input and minimize the timeline after database lock.

Understanding the New USP Chapter 1224 for Analytical Method Validation

is being presented by Dr. Ludwig Huber, Director, of LabCompliance and airs on Wednesday, June 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com

It is important to maintain the validated state when transferring validated methods between laboratories and sites, so that the receiving laboratory can produce the same reliable results. However, to date there has been no official guidance on what exactly is expected to maintain 'the validated state'. That is changing. The U.S. Pharmacopeia (USP) recently published a proposal for a general chapter <1224>, which will become official with USP 35. Also, the FDA has released an official guidance on how to conduct and document method transfer.

This audio conference presentation looks at FDA and international expectations for method transfer, and discusses how to properly conduct and document a transfer. It explores the various approaches and laboratory responsibilities, and looks at how to develop a transfer plan and pre-approval protocol. The speaker also provides attendees with an understanding of USP and FDA requirements, and provides recommendations and tools for effective implementation.

Reducing Your Risk Under the FCPA & Other Anti-Corruption Laws

is being presented by Jesse A. Witten, Partner, with Drinker Biddle & Reath LLP and airs on Tuesday, May 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The U.S. Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have made enforcement of the Foreign Corrupt Practices Act (FCPA) a top priority, especially as it relates to pharmaceutical and medical device manufacturers. No pharmaceutical and device manufacturer can expect to evade a government investigation indefinitely. Even smaller companies need to be able to demonstrate that they exercise due diligence, either in the event of an investigation or if they ever seek to partner or merge with a larger company.

This audio conference presentation provides guidance for companies with international operations on how best to develop and implement a set of internal controls to reduce enforcement risk under the FCPA and other international anti-corruption laws.

Re-examinations, Litigation, and Other Mechanisms for Addressing “Problem” Patents

is being presented by Kevin McCabe & Dr. Eldora Ellison, Directors, Biotechnology/Chemical and Litigation Groups Sterne, Kessler, Goldstein & Fox P.L.L.C. and airs on Tuesday, June 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Sooner or later, nearly all high technology companies encounter one or more patents that may present a roadblock to bringing a product to market or to conducting important research.

This audio conference presentation provides an overview of the legal tools available in the United States to help address such “problem” patents. In particular, our speakers provide a detailed discussion of patent re-examinations and the interplay between re-examinations and litigation. Additionally, the presentation looks at other mechanisms that may be used when one encounters a problematic patent, such as licensing, design-arounds, protests, interferences, and arbitration.

This presentation is informative both for companies that are concerned with patents held by others, as well as companies that may seek to enforce their own patents and thus subject such patents to validity challenges. The knowledge of these tools, and their various pros and cons, provided through this presentation give companies needed information to assist their strategic decision-making.

Navigating China's Medical Device Regulations

is being presented by Chang-Hong Whitney, MBA, RAC, President, Whitney Consulting Ltd. and airs on Thursday, June 16th, 2011. For more details, or to register please visit our site at www.fxconferences.com

China's medical device regulations have evolved greatly over the past twenty years. However, navigating the Chinese regulatory system is still a daunting task for many western companies. This audio conference provides essential information on the Chinese regulatory requirements for medical devices. Our speaker provides attendees with first-hand insight and guidance, drawing upon the experience and knowledge gleaned from daily dealings with SFDA officials and through managing numerous registration projects in China. Attendees learn the essential requirements for getting their medical products approved for the Chinese market, the time and costs involved, issues to watch for and obstacles down the road.

Alliance Management - Bridging the Gap Between Drugs and Diagnostics

is being presented by David Kern, RAC MBA, Senior Director, Myraqa and airs on Tuesday, July 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Alliance management has long been a core competency in many drug companies, as a way of helping to ensure that compounds discovered by biotech partners make their way to the market. Yet the relationship between drug and diagnostics companies has been a challenge for both sides. Understanding how to manage these strategic relationships is critical to the successful development of a companion diagnostic test, and there can be consequences for a drug company not taking an active role in these alliances.

In this audio conference presentation, our speaker examines the issue, and discusses when and how to start looking for a diagnostics partner, how to structure the relationship, and how best to work together for mutual benefit.

Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites

is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Wednesday, June 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com

GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.

In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

FDA on the Edge: What's Next for 510(k)?

is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, June 2nd, 2011. For more details, or to register please visit our site at www.fxconferences.com

Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.

For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.

Conducting Vendor Audits from an IT Perspective

is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, May 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com

In the past, vendor audits were standard practice prior to the purchase of, or as part of validating, an IT system. As resources have gotten tighter and life sciences companies perhaps perceived less of a threat from the FDA on computer validation, many companies have moved away from performing vendor audits.

These days, FDA is scrutinizing IT systems, and has not overlooked the tendency with many companies to try and justify their way out of conducting vendor audits. This is true for both the outsourcing of processes to CROs and the implementation of IT systems on-site. With FDA’s focus on computer systems as part of PAIs and other inspections, ignoring vendor audits is a risk you can’t afford to take.

This audio conference presentation takes attendees through the elements of a vendor audit for both the purchase of software for a validated system, and for outsourcing of services that include IT systems such as clinical trial management.

Regulatory Requirements for Medical Device Calibration Programs

is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, June 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72, while the ISO 13485 requirements are in Clause 7.6.

Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to aid in understanding accuracy and precision.

This audio conference explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The audio conference describes the concepts of accuracy and precision that define the measuring equipment’s requirements, and explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.

The 2011 ISO 14155 Revision: Keeping SOPs Up-to-Date

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Thursday, June 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com

The ISO 14155 standard for the conduct of clinical trials -- published in 2003 and updated in 2009 -- was revised again in 2011. However, some companies still haven't updated their standard operating procedures (SOPs) to reflect the 2009 revision, and lack the internal processes to ensure that SOPs are always updated in concert with new or revised regulations and guidance.

This audio conference presentation outlines a process by which companies can keep up-to-date with changes in regulations and guidance, and make sure their SOPs and working practice documents (WPDs) are in compliance with the latest regulatory requirements and guidance.

Our speaker uses the latest ISO 14155 guidance update as an example, to show how a robust process for regulatory intelligence gathering and SOP review can keep you on top of the latest standards. The presentation reviews the important changes in this latest version of the ISO 14155 guidance, and draws upon recent real-life client experience to look at how these can be incorporated into revisions to SOPs and WPDs.

Record-keeping and Recall Requirements Under the New FSMA

is being presented by Mitchell S. Fuerst, Esq., Managing Partner, with Fuerst & Ittleman, P.L. and airs on Thursday, June 9th, 2011. For more details, or to register please visit our site at www.fxconferences.com

With the passage of the FDA Food Safety Modernization Act (FSMA), a lot of attention has been devoted to the new recall authority granted to the FDA. While the FDA now has the authority to issue mandatory recalls when it deems it is necessary to protect against serious adverse health consequences, this is not the only consequence of mandatory recall authority. With recall authority comes a variety of new record-keeping requirements that food growers and manufacturers must abide by under the FSMA.

Although the FSMA limits this recall authority to situations where the food producer has not voluntarily recalled its own goods, the record-keeping requirements are broader in scope and allow the FDA to request business records before a recall is ever contemplated. Where the FSMA gives authority to FDA to require food producers to turn over records before a recall has been ordered, these record-keeping requirements are a central feature of the mandatory recall scheme.

Knowledge of these record-keeping requirements is critical to understanding the entire recall scheme. This audio conference presents an in-depth look at the new record-keeping requirements in the FSMA. Beginning with an overview of the requirements and FDA recall authority in general, the speaker explores specific obligations imposed by the FSMA, and examines the record-keeping requirements within the overall recall scheme to provide an understanding of how the provisions all work together in practice.

EU Medical Device Classification - Overview and Update

is being presented by Mika Reinikainen, Managing Director, with Abnovo Ltd. and airs on Tuesday, May 10th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.

This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.