Meeting the Requirements: Blending REMS Science & Operational Execution

We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.

In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.

Meeting the Requirements: Blending REMS Science & Operational Execution is being presented by Mark Nelson Tyrrell, Kathleen Kushner & Jerome Wilson, Director, Safety and Risk Management, Scientific Affairs Director & Senior Scientific Affairs Director, with PRA International and airs on Tuesday, June 16, 2009. For more details, please visit our site at www.fxconferences.com

Regulatory Considerations for R&D in Central & Eastern Europe

Central and Eastern Europe continues to be an attractive place for conducting clinical trials, with rapid patient recruitment and high quality of data. At the same time, the clinical trial industry's single greatest challenge continues to be the regulatory process, which has a key impact on the duration of the study start-up period and on timely patient recruitment.

Regulatory requirements in CEE countries went through dynamic changes within the last couple of years, mostly as a result of the accession of several countries to the European Union, as well as increasing demand for the adjustment of local regulations to international standards coming from the pharma industry. However, regulatory changes still seem to be an ongoing process, and the greatest challenge for sponsors and CROs.

This presentation focuses on major regulatory-related problems, with special attention to site contracting problems, and show practical ways of overcoming them in order to speed up the drug development process.

Regulatory Considerations for R&D in Central & Eastern Europe is being presented by Dr. Malgorzata Szerszeniewska, CEO, with Unimed and airs on Tuesday, July 7, 2009. For more details, please visit our site at www.fxconferences.com

Accelerating Your Innovation Pipeline

Innovation as a distinct management discipline is moving from an academic concept into real-world practice, as many companies progress from a project-by-project approach to a more holistic management system. For a company to grow and renew itself, it must move beyond incremental innovation and build a sustainable capability for innovation. But how do you get started?

In this audio conference, Dr. Gina O’Connor shares insights gained from 15 years of research on how to evolve from an ad hoc, hit-and-miss approach to innovation, to a portfolio of options tied to a company’s strategic intent. This presentation discusses ways to create a more strategic, systematic approach to innovation, and how to orchestrate innovation capacity in response to both favorable and constrained business conditions.

Accelerating Your Innovation Pipeline is being presented by Dr. Gina O'Connor, Academic Director, with Radical Innovation Research Project and airs on Wednesday, July 15, 2009. For more details, please visit our site at www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

Combination product manufacturers are faced with a major challenge to implement a quality system that complies with applicable FDA Good Manufacturing Practices (GMPs) and Quality System Requirements (QSRs). For 10 years, FDA has been progressively developing regulations for this complex area, yet has provided very few formal guidance documents to help manufacturers.

In this audio conference, you learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? was presented by Linda Alexander, CEO and Founder, with Alquest and aired on 2008-09-18. For more details or to download this conference, please visit our site at www.fxconferences.com

Bulletproofing Personnel Policies Against Litigation

Are you concerned that your HR policies and processes might be leaving you vulnerable to lawsuits? No one sets out to create policy risks and personnel litigation. Yet every year a new crop of employee lawsuits are spawned by claims of inattention, inconsistency or unfairness in applying organization policies.

Learn how to avoid the costly loopholes in personnel policy and you could potentially save your company. This informative seminar helps you learn the basis of good policy and the importance of enforcing it consistently. There are basic rules you must know about workplace grievances and disciplinary issues to limit or avoid negative action altogether, especially litigation.

Grandma was right, you know. An ounce of prevention is worth a pound of cure.

Bulletproofing Personnel Policies Against Litigation was presented by Jay R. Rush, Director of Contracts & Legal Compliance, with Policy Technologies International and aired on 2007-10-18. For more details or to download this conference, please visit our site at www.fxconferences.com

How to Write for a Global Audience

In today's world, technical documentation must be designed for multiple audiences - both the users who read the text in translation, and those for whom English is a second language. By using Controlled English and authoring with an eye to translation, companies can make the entire process of product globalization faster, cheaper and less prone to errors.

This audio conference provides some basic guidelines on how to write for a global audience, enabling attendees to reduce the cost and improve the quality of translations, improve training and customer support, and protect their companies from litigation under the "failure to warn" principle.

How to Write for a Global Audience was presented by John Smart, President, with SMART Communications. For more details, or to purchase a download of this event, please visit our site at www.fxconferences.com

How do Executives Evaluate Distance Training?

According to the American Society for Training and Development, over $30 billion was spent in 2006 on "technologically-mediated training." This is about 25% of all the funds spent on training in the United States that year. Is this large expenditure actually improving performance? How is distance training evaluated by executives who make these important budgeting decisions?

This conference presents the results of a two-year study of how executives evaluate distance training, which shows that executives use a wide variety of standards to evaluate distance training. Attendees learn how to use best practice to evaluate the success of their distance training programs.

How do Executives Evaluate Distance Training? is being presented by Dr. Paul Hardt, Core Faculty Trainer, with Capella University and airs on Thursday, July 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Saving Time and Money With Rapid eLearning

It used to be that elearning required specialized programming skills and a lot of time to develop. Today, that is no longer the case. With modern rapid elearning tools, building courses has gotten a lot easier and that is helping organizations deliver their training at the speed of business. But not all elearning tools are created equal, and views have changed on what makes for an effective elearning experience. In this audio conference, speaker Tom Kuhlmann, author of the Rapid Elearning Blog, discusses effective tools and strategies, and how rapid elearning tools can save you time and money.

Saving Time and Money With Rapid eLearning is being presented by Tom Kuhlmann, with Articulate and airs on Thursday, June 25, 2009. For more details, or to register to this event, please visit our site at www.fxconferences.com

SPL & Beyond: XML in the Life Sciences

As Structured Product Labeling (SPL) continues to evolve and become adopted throughout the FDA, organizations must ensure their original approach to SPL compliance is the best strategic fit for the enterprise. Initially, the goal for most organizations was focused solely on implementing systems and/or processes to achieve SPL compliance. Depending on your approach, SPL compliance can either result in additional time and cost to the overall submission process, or provide long-term value across the enterprise.

With additional XML-based standards under development, and the ability for structured content to drive efficiencies throughout an enterprise, it is prudent to review your overall approach to structured content authoring and publishing. This presentation looks at how XML can be used to manage content for SPL submissions to the FDA, Product Information Management (PIM) submissions to EMEA, as well as other uses such as standard response letters for customer contact centers.

SPL & Beyond: XML in the Life Sciences was presented by Don Bridges & Joe Jenkins, Commercial Technical Documents Manager, Data Conversion Laboratory (DCL) & Life Sciences Market Director, RWD Technologies and aired on 2006-04-06. For more details, or to download this conference, please visit our site at www.fxconferences.com

Controlling Schedule II Narcotics: Operational Challenges in Conducting Clinical Trials

Many drugs that have safe and effective medical uses in clinical trials can also carry a potential risk for abuse. The United States Drug Enforcement Administration (DEA) has grouped these drugs into schedules, ranking them by their potential for abuse, from highest to lowest. This conference explores the steps necessary to comply with DEA and state regulations. It also focuses on the regulations surrounding use, distribution and control of Schedule II narcotics in a clinical trial, as well as the roles and responsibilities of the sites, monitors, managers and sponsors.

Controlling Schedule II Narcotics: Operational Challenges in Conducting Clinical Trials is being presented by Michelle D'Ovidio & Vanesa Castillo, Product Manager and Project Director, with Covance Periapproval Services and airs on Wednesday, June 3, 2009. For more details, or to register for this event, please visit our site at www.fxconferences.com

3 Steps to Successful Translation Management

Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need a true partner that can help them effectively manage the translation process.

This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.

3 Steps to Successful Translation Management was presented by Andres Heuberger, President, with ForeignExchange Translations and aired on 2009-01-30. For more details, or to purchase a download of this event, please visit our site at www.fxconferences.com

Clinical Research in Central & Eastern Europe: Developments and Challenges

In recent years the countries of Central and Eastern Europe have seen many political and economic changes which have affected the clinical research market. Changes in EU member status, economic standards, labor policy and political changes all effect the environment for clinical trials in this region. In some countries these changes are leading to a less competitive arena for clinical trials, as evidenced by more regulatory hurdles, saturation of sites, and highly unstable labor markets for clinical research personnel as the demand for experienced staff outweighs the supply.

At the same time, there are new countries on the horizon which are just getting started in clinical trials and could offer many opportunities but also come with their challenges. Central and Eastern Europe can still provide excellent recruitment with costs savings but the planning of studies needs to be done with more sophistication than was previously required to get good results.

This presentation focuses on the current and future challenges related to the clinical studies in the region, provide background on the forces that have created the current picture and suggest strategies for success in the future based on actual case studies and experience.

Clinical Research in Central & Eastern Europe: Developments and Challenges was presented by Dr. Malgorzata Szerszeniewska, President, with AbCRO and aired on 2008-07-10. For more details, or to download this conference please visit our site at www.fxconferences.com

How to Successfully Execute an FDA Product Recall

All industries regulated by FDA are expected to have robust product designs, well-controlled manufacturing processes, effective quality control measures, and a comprehensive quality system to identify potential problems, investigate them, and take appropriate actions. Product recalls are an unwelcome, but important, part of the spectrum of corrective and preventive actions that industry uses.

In this audio conference, the speaker reviews recall regulations, initiation and conduct of recalls, and provides tactical recommendations, focusing on medical devices, but with broader applicability. The presentation serves as an introduction for those new to the topic, and also as a refresher for those already familiar with recalls.

How to Successfully Execute an FDA Product Recall is being presented by Dr. Bruce MacFarlane, Principal Project Manager, with Alquest and airs on Tuesday, June 23, 2009. For more details or to register please visit our site at www.fxconferences.com

ASTM F 2575-06: A Practical Guide for Achieving Translation Quality - Updated

After many years lacking industry-specific standards, translation providers and users now have a few to choose from. The two that have created the most buzz are the European standard, EN 15038-2006, and the American standard, ASTM F 2575-06. Translation providers are clamoring to declare themselves compliant with both of these. While the EN standard is focused more on establishing a baseline for providers, the ASTM standard serves as a better real-world guide for providers and clients.

The overriding theme of ASTM F 2575-06 (Standard Guide for Quality Assurance in Translation) is one of cooperation between client and provider. The writers of the standard understand that quality in translation is a collaborative process. The document is filled with explanations and definitions of industry-specific terms and practices, as well as practical tips for working together with a vendor to build a foundation of quality.

This audio conference discusses ASTM F 2575-06, its history and development, key points of its sections, its applicability to certifications and testing, and ways in which companies can use the standard to work with vendors to achieve the highest level of quality.

ASTM F 2575-06: A Practical Guide for Achieving Translation Quality is being presented by Jason Heaton & Steve Lank, Marketing Manager & Chairman, with ForeignExchange Translations & ASTM Subcommittee F15-48 and airs on Thursday, May 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Optimizing Your Chemistry, Manufacturing & Control Program

Chemistry, Manufacturing, and Controls (CMC) programs are an integral part of the development process which brings a drug from the preclinical phase to the market. Without a CMC program that is properly integrated with the clinical, non-clinical, and marketing programs, the entire development cycle can be delayed, resulting in lost time, revenues and market life cycle. However, the extent of necessary activities in CMC programs can vary depending on the development phase of the drug.

In this audio conference we explore how the skillful combination of drug characterization, manufacturing and packaging processes, analytical test methodology, compliance with applicable regulations and adequate documentation all help to ensure that the CMC portions of an application meet the necessary requirements, as well as supporting the clinical and nonclinical studies being performed to establish the safety and efficacy of the drug.

Optimizing Your Chemistry, Manufacturing & Control Program is being presented by Dr. Miguel de Soto-Perera, Vice President of Pharmaceutical Sciences, with Beckloff Associates, Inc. and airs on Wednesday, June 10, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Dealing With the Media and Getting Your Message Out

Do you cringe at the thought of being asked tough questions by reporters? Do you find yourself perspiring and getting tongue-tied under rapid-fire questioning? You’re not alone. But whether you are dealing with a corporate crisis or simply promoting a new product, being able to work effectively with the media is a valuable skill to acquire.

In this dynamic and information-packed presentation, top consultant and political communications commentator and critic Ruth Sherman highlights the skills necessary to make the most of your media contact. Participants learn what and what not to do, as well as how to promote a positive, professional image whether on-camera, microphone or during a live press conference.

Drawing on 18 years of experience as a consultant to corporate, political and celebrity clients, the speaker shares stories from the front lines and provides attendees with the tools to feel confident and prepared for that next encounter with the media.

Dealing With the Media and Getting Your Message Out is being presented by Ruth Sherman, President, with Ruth Sherman Associates, LLC and airs on Wednesday, June 17, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Conducting Drug Trials in Asia Pacific

With constant pressure to reduce the cost of drug development and to find eligible subjects for clinical trials, developing areas of the world are of increasing interest to trial sponsors. But how does the quality of data compare with traditional sites? And what about the rate of recruitment? Do these alternative sites really offer a substantial benefit in terms of time and cost savings?

This presentation, the second in a series featuring speakers from Covance addressing alternative site selection, focuses on the opportunities and the reality of performing clinical trials in the Asia Pacific market.

Conducting Drug Trials in Asia Pacific was presented by Dr. Helen Ormandy, Director, Centres of Excellence, with Covance Asia Pacific and aired on 2006-05-04. For more details or to download this conference, please visit our site at www.fxconferences.com

To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com

Executing Phase IV Studies: What Works, What Doesn't

Successful execution of any Phase IV study requires that study processes be streamlined enough to meet the often rapid and commercially-dependent timelines, but rigorous enough to produce data that is rooted in good science and able to stand up to peer review. This balance is often difficult to maintain in the face of changing regulatory and commercial environments.

In this audio conference presentation, the speaker utilizes case studies from recent Phase IV studies to explore what operational strategies worked, what was lacking, and how the CRO/Sponsor relationship was managed.

Executing Phase IV Studies: What Works, What Doesn't was presented by Peggy Schrammel, Vice President Clinical Research, with PharmaNet and aired on 2008-05-29. This conference is available for download at www.fxconferences.com

On-Site Clinics: Next Big Opportunity or Next Big Threat for Pharma?

More than 1200 of the largest companies in the US have already established more than 1800 on-site clinics to serve the needs of their employees and their families. These clinics have the potential to reshape pharmaceutical sales for years to come. On-site clinics are poised for double-digit growth, and by some estimates could account for over 10% of all pharmaceutical prescriptions written for those under 65 by the year 2015. They will cover both branded and OTC products, and many will have their own pharmacies for immediate dispensing. Most are likely to be linked into sophisticated health management programs, which will be designed to act as high-value compliance programs paid for by the employers. But is this an opportunity or a threat to industry?

Certainly there is the possibility that many of the companies will launch their own formularies, limiting the types of remedies covered. In this audio conference our speakers discuss this new frontier, including who is leading the charge with on-site clinics and what it means for the pharmaceutical industry. As an added bonus, attendees will receive a copy of Fuld’s On-Site Clinics white paper.

On-Site Clinics: Next Big Opportunity or Next Big Threat for Pharma? is being presented by Leonard Fuld & Mike Ratcliffe, Founder & President and Director of Research, with Fuld & Company, Inc. and airs on Thursday, June 11, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Adaptive/Novel Designs in Oncology: Overview & Issues

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

Adaptive/Novel Designs in Oncology: Overview & Issues is being presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and airs on Tuesday, May 19, 2009. For more details please visit our site at www.fxconferences.com