e-Consent: An Idea Whose Time Has Come

This presentation discusses the key elements to consider in implementing e-informed consent. Based on currently implemented online trial consents, crucial steps in the implementation process will be described.

Drawing from current national and international trial experience with electronic multimedia informed consent and the research literature on multimedia consent, presenters will discuss key lessons learned concerning subject and trial characteristics that impact on implementation of electronic consent and its’ success in a clinical trial. The session discusses a decision path for determining if e-consent can be effectively implemented for a trial.

e-Consent: An Idea Whose Time Has Come was presented by Dr. Susan Brink, ConsentSolutions, Inc. & Jovianna DiCarlo, Accugenex Technologies, Inc. and aired on 2008-12-03. For more details, or to download this event please visit our site at www.fxconferences.com

Electronic vs. Paper Data Capture: Which Option is Best for Your Trial?

There are many factors that come into play when deciding whether to employ electronic or paper data capture (EDC or PDC) for data management of a clinical trial. Most people focus on the perceived benefits of EDC, mainly relating to the ability to look at data on an ongoing basis. But there are other aspects that require consideration, such as set-up time, cost, and whether there are patient-generated data. These considerations are particularly important for small companies who run few trials, and therefore do not have in-house data management capabilities.

This presentation covers all aspects of EDC vs. PDC, describing the pros and cons of each for different situations. For example, what is the most cost-effective solution for a medical device company that runs one trial a year on average, has no in-house data management capability, and whose trials involve few patients, long follow-up periods, and patient-generated data? Conversely, what is the best solution for an in-vitro diagnostics company that performs large studies of several thousand patients with a very small case report form, almost no follow-up period, and the requirement to import large amounts of laboratory data?

Electronic vs. Paper Data Capture: Which Option is Best for Your Trial? is being presented by Helen Colquhoun, CEO, with Pleiad Inc. and airs on Wednesday, February 24, 2010. For more details or to register, please visit our site at www.fxconferences.com

Communicating Complex Technical Information to Non-Technical Audiences

If you are a scientist, researcher, QA/QC, or product development expert, you are dealing with complex concepts, specialized material, and information that may have taken years to master. But sooner or later, you need to communicate what you know to audiences who are not as technically experienced and knowledgeable as you: your company’s management, regulatory bodies and the general public.

This challenge is difficult. On the one hand, you need to ensure that what you communicate is technically correct and appropriately precise. On the other hand, you need to make complex ideas clear, easy to understand and memorable. How do you strike that balance, and tread that fine line between talking over the head of your audience and "dumbing down" your presentation to the extent that your core message is lost or distorted? This audio conference provides attendees with proven techniques for meeting the communication challenge.

Communicating Complex Technical Information to Non-Technical Audiences was presented by Karl Keller, Principal, with Communication Partners and aired on 2009-05-21. For more details or to download this event, please visit our site at www.fxconferences.com

The 2010 MDD Revisions and What They Mean for Translation

Companies are scrambling to meet the new requirements of the 2010 European Medical Device Directive (MDD). One of the most challenging components of the new directive is the increased focus on language translation for software and labeling. The updated MDD states that software that is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold. In the past, companies have been able to avoid software translation by stating that the great majority of professional device users can read English.

Software translation is no small feat. It can be expensive, time-consuming and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly. Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.

This presentation focuses on the implications of the 2010 MDD for translation. It also covers specific best practices and common pitfalls in software translation and labeling translation, and looks at some of the most common root causes of inaccurate labeling and how to avoid them.

The 2010 MDD Revisions and What They Mean for Translation is being presented by Jason Heaton, with ForeignExchange Translations and airs on Wednesday, February 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

Achieving Global Registration of Complex Biosimilars

Similar biological medicinal products (biosimilars) became a reality in Europe when the CHMP adopted positive opinions for the two human growth hormones Omnitrope and Valtropin. Since then, more than ten marketing authorization applications for biosimilar products have been approved. However, there have also been failures. Currently, there are biosimilar products being developed for the more complex biopharmaceuticals such as monoclonal antibodies, and soon those will be submitted for registration.

This audio conference details the relevant regulatory procedures, regulations, guidelines and regulatory experience to date with complex biosimilars. The speaker identifies and discusses the challenges (CMC, non-clinical and clinical) concerning the demonstration of biosimilarity for complex biosimilars, and proposes possible global development plans.

Achieving Global Registration of Complex Biosimilars is being presented by Robert Blakie, Director & General Manager, with ERA Consulting (UK) Ltd. and airs on Thursday, February 25, 2010. For more details or to register, please visit our site at www.fxconferences.com

Japanese Medical Device Submission Requirements & Structure

Boasting the second-largest medical device market in the world, it is no small wonder that Japan appeals to manufacturers. However, the Japanese market is also highly regulated, which can mean slow approval times and increased costs. When launching a medical device in Japan, it is key for managers to understand the structure, contents and various challenges associated with Japanese regulatory submissions in order to control these costs and manage regulatory timelines.

This audio conference provides a complete overview of the typical Japanese medical device submission, including labeling and linguisitc requirements. Our speaker outlines the different types of submissions and the structure of each, and provides details on the specific information that must be included in the final dossier.

Japanese Medical Device Submission Requirements & Structure is being presented by Michael Halper, President, of Small World Medical and airs on Thursday, February 18, 2010. For more details or to register, please visit our site at www.fxconferences.com

Complying with EU Antitrust Laws

A 60-million Euro fine for AstraZeneca. A 10-million Euro fine for Bayer. Dawn raids at Pfizer, SanofiAventis and GlaxoSmithKline. Pharma and medical device companies have been targeted in a number of major antitrust investigations in Europe in recent years. It is absolutely vital that any company doing business in Europe be aware of existing antitrust provisions, and perhaps especially important for those in the life sciences. This presentation gives a general overview of EU antitrust law, and highlights those areas of particular relevance to medical device and pharmaceutical companies. The presentation places added emphasis on identifying special areas of risk, such as agreements restricting competition, information sharing between competitors, distribution agreements and abuse of market-dominating positions. Our speakers also discuss when you should seek legal assistance, and how to behave in the event of dawn raids.

Complying with EU Antitrust Laws was presented by Marc Besen & Dr. Christian Mayer, Partner & Associate, with Clifford Chance and aired on 2009-03-10. For more details or to download this event, please visit our site at www.fxconferences.com

e-Consent: An Idea Whose Time Has Come

This presentation discusses the key elements to consider in implementing e-informed consent. Based on currently implemented online trial consents, crucial steps in the implementation process will be described.

Drawing from current national and international trial experience with electronic multimedia informed consent and the research literature on multimedia consent, presenters will discuss key lessons learned concerning subject and trial characteristics that impact on implementation of electronic consent and its’ success in a clinical trial. The session discusses a decision path for determining if e-consent can be effectively implemented for a trial.

e-Consent: An Idea Whose Time Has Come was presented by Dr. Susan Brink, ConsentSolutions, Inc. & Jovianna DiCarlo, Accugenex Technologies, Inc. and aired on 2008-12-03. For more details or to download this event, please visit our site at www.fxconferences.com

How to Measure Quality in Clinical Translations

The quality of translation lies in the eye of the beholder, making a "good" or "bad" judgment highly subjective. Miscommunication and stylistic preferences often mark these discussions and a surprising number of organizations and translation vendors have no quality system in place at all.

When there is no single, accepted definition of translation quality, how can clinical organizations measure it? This audio conference will help you better understand the proven methodologies for measuring translation quality and sort through the myriad options available to find a solution that is right for you.

How to Measure Quality in Clinical Translations was presented by Andres Heuberger, President & Jason Heaton, Marketing Manager, with ForeignExchange Translations and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

Patent Portfolio Strategies in the Post-KSR Environment

Essential information for legal counsel and product development teams!

The Supreme Court’s decision in KSR v. Teleflex profoundly changed the landscape for biopharma companies and medical device manufacturers when it comes to building patent portfolios and managing them. More recently, the Federal Circuit’s Bilski decision in October 2008 added yet another dimension of complexity.

In this audio conference, we examine how this new environment changes the work of managers and professionals in product development teams, as well as patent professionals seeking to protect innovations. The presentation looks at how to identify and strengthen patents that might be vulnerable to obviousness attacks, and discusses ways to write and prosecute them to mitigate that risk.

Patent Portfolio Strategies in the Post-KSR Environment was presented by Bruce D. Sunstein, Co-Founder & Partner, Bromberg & Sunstein LLP and aired on 2009-02-12. For more details or to download this event, please visit our site at www.fxconferences.com

Labeling for Diagnostic Devices: Best Practices

Since Dec. 7, 2003 in-vitro diagnostic (IVD) products must feature the CE mark to be sold in the European Union. With an ever-growing list of languages to be supported, IVD industry faces a dilemma: How can companies provide the required information in multiple languages, while making the information readable on a variety of sizes of labels?

The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many diagnostics companies are struggling with the issues that surround multilingual label design and international symbology.

Labeling for Diagnostic Devices: Best Practices was presented by Andres Heuberger, President, ForeignExchange Translations and is previously recorded. For more details or to download this event, 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 was presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and aired on 2009-05-19. For more details or to download this event, please visit our site at www.fxconferences.com

Finding and Assessing Global Drug Development Partners

It takes, on average, somewhere around 15 years and a billion dollars to take a drug development project “from bench to bedside.” One factor contributing greatly to that protracted timeline is the significant difficulty in finding and then collaborating with qualified partners. The problem is exacerbated when development is taking place on a global scale. Asking colleagues and consultants might net you a recommendation for the largest CROs, but if you need a good regulatory consultant familiar with Chinese Investigator Document Review, for example, you could be out of luck. And even when a pharma company does identify a service provider, the interaction isn't straightforward: there is no simple way of searching for and comparing services, profiles and reputation.

There are myriad websites designed to help consumers find hotels and local businesses, and they have made these transactions much more transparent. However, the life sciences industry has lagged behind: companies still mainly generate leads on development partners largely by word of mouth and by attending industry trade shows and conferences. In this audio conference, our speaker explores new ways to connect, evaluate and engage drug development partners around the world.

Finding and Assessing Global Drug Development Partners is being presented by Jae Chung, Founder & CEO, of goBalto and airs on Tuesday, February 9, 2010. For more details or to register, please visit our site at www.fxconferences.com

Current FDA Thinking on Risk Evaluation and Mitigation Strategies

In September of 2009, the FDA issued a draft guidance for industry on the format and content of a proposed risk evaluation and mitigation strategy (REMS), which included REMS assessments and proposed REMS modifications. Many industry experts are working to manage the detailed requirements of this new pharmacovigilence standard to include more and tighter control over drug uses.

This session provides insight into medication guides, patient package inserts, communication plans, timelines and other elements to ensure safe use. Attendees receive helpful tips about the format and contents of REMS submissions, as well as some good practices for execution of REMS strategies.

Current FDA Thinking on Risk Evaluation and Mitigation Strategies is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Thursday, February 11, 2010. For more details or to register, please visit our site at www.fxconferences.com

WEEE and RoHS Revisions: Implications for Medical Device Manufacturers

The WEEE and RoHS Directives are currently undergoing a "recast" in the European Union, and both will have significant implications for the medical device industry. This is particularly true in the case of the RoHS Directive, where medical devices will almost certainly be included for the first time. As a result, there will be important new considerations for component procurement, design, manufacturing and support. Manufacturers need to understand that obtaining exemptions is likely to become more complex as well.

In this conference, our speaker explains how the changes to the WEEE Directive as proposed will introduce recovery and recycling targets, and may make trans-boundary shipments of articles/assemblies for repair, investigation or refurbishment more complicated.

WEEE and RoHS Revisions: Implications for Medical Device Manufacturers is being presented by Andrew Vaughan, Environmental Systems Specialist, with Donawa Lifescience Consulting and airs on Thursday, February 4, 2010. For more details or to register, please visit our site at www.fxconferences.com

Using IT to Drive Quality Healthcare

Technology has evolved to the critical point of capability and proven maturity to enable appropriate healthcare applicability. Health information technology has the ability to provide improved healthcare quality, more efficient delivery of care and earlier diagnosis of disease, while at the same time positively affecting your bottom line.

In this presentation our speaker reviews the pressures on healthcare, the IT-related capabilities needed, and proof from real organizations of outcomes achieved through IT-enhanced healthcare. The presentation also provides illustrations of improved patient safety and practitioner efficacy through IT-enabled healthcare.

Using IT to Drive Quality Healthcare is being presented by Dr. Steven Shaha, Principal Outcomes Consultant, with Eclipsys Corporation and airs on Wednesday, February 3, 2010. For more details or to register, please visit our site at www.fxconferences.com

Clinical Trials: Why is India Irresistible?

In recent years, India has proven itself as a solid-performing region for conducting clinical trials. As it has evolved and emerged, it has caught the attention of global pharmaceutical and biotech companies. The reason for the growth in this region is simple: India, with a population of over 1.15 billion people, has one of the largest patient populations in the world. In addition to its large patient population, India has nearly 700,000 specialty hospital beds, 290-plus medical colleges, and skilled English-speaking medical professionals.

In this session we examine the factors that have made India one of the hottest places in the world to conduct clinical trials. Attendees come away with proven strategies to overcome challenges and maximize the “India advantage.”

Clinical Trials: Why is India Irresistible? is being presented by Dr. Pramod Kabra, Director of Clinical Operations, with PRA International and airs on Thursday, January 28, 2010. For more details or to register, please visit our site at www.fxconferences.com

Leading Virtual Teams in the Pharma & Biotech World

The majority of work that gets done in the pharma and biotech industry is done with teams. But what has changed in the last decade is that most of these teams are now “virtual,” with many team members geographically dispersed. Not only are these team members remotely located, but they often work in both different time zones and country cultures.

In this audio conference, our speaker, who has travelled the globe working with virtual teams, offers insights and tips for building relationships and trust, maximizing collaboration, and achieving world-class results without the benefit of face-to-face teamwork.

Leading Virtual Teams in the Pharma & Biotech World is being presented by Lynda McDermott, President, of EquiPro International and airs on Tuesday, January 26, 2010. For more details or to register, please visit our site at www.fxconferences.com

Points to Consider when Presenting Documents for an FDA Inspection

It used to be that all controlled documents were stored as hard copy in a document center where they would be signed out for presentation to inspectors. These days, records are stored in a variety of computerized systems. They are typically printed out in the last minute and with minimum review. When these records are then made available to inspectors, they are often incomplete and inaccurate.

In this audio conference, our speaker provides an understanding of offical records, explores different strategies, and explains how to prepare your records for an FDA inspection in a more complete and accurate manner.

Points to Consider when Presenting Documents for an FDA Inspection is being presented by Ronald Eisenwinter, Quality & Regulatory Consultant and airs on Tuesday, February 16, 2010. For more details or to register, please visit our site at www.fxconferences.com

Are You Ready for MDD Amendment Directive 2007/47/EC?

Time is running out – ease your MDD compliance strategy stress with detailed guidance from a leading expert!

The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.

In this audio conference, our speaker provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.

Are You Ready for MDD Amendment Directive 2007/47/EC? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, January 27, 2010. For more details or to register, please visit our site at www.fxconferences.com

Brand Development and Enforcement Strategies

In uncertain economic times, it is vital that companies develop strong, identifiable, unique and protectable trademarks and brands. In this presentation, the speaker covers the entire range of brand development, including brand selection, trademark searching and counseling, international brand registration and brand expansion.

Brand owners must also protect against encroachment. This includes developing strategies to safeguard against improper importation of counterfeit or infringing merchandise, and knowing the steps that can be taken at the border to prevent it. Other enforcement targets discussed include counterfeiters operating at the local level; distributors, exporters and manufacturers operating up the commercial line; and infringers who do not directly copy a brand, but use marks likely to cause confusion. The presentation also covers brand development and enforcement over the Internet.

Brand Development and Enforcement Strategies was presented by Anthony F. Lo Cicero, Intellectual Property Attorney, with Amster Rothstein & Ebenstein LLP and aired on 2008-11-25. For more details or to download this event, please visit our site at www.fxconferences.com