Device e-Labeling & Regulatory Compliance in the EU

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

Device e-Labeling & Regulatory Compliance in the EU is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, June 18, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Determining Feasibility in Global Clinical Trials

The single greatest challenge to drug development today is successful patient accrual. The sheer volume of actively recruiting trials advertised by the NIH -- nearly 16,000 in 2006 -- illustrates the extensive competition for patients to participate in clinical trials in the United States. In an effort to access more patient populations to address these issues, it has become necessary to include a global mix of countries.

The key to including sites outside the United States is understanding exactly where the selected patient populations are located. Detailed feasibility is a critical step to planning and conducting successful global clinical trials. Understanding the medical standards of care, local healthcare systems, national health insurance and reimbursement, drug importation and tax implications, local regulatory requirements and treatment paradigms are all essential to determining where globally to place a specific clinical trial.

This presentation focuses on how to perform global feasibility to aid in the planning and conduct of clinical trials to economize your development times and clinical trial costs and explores the benefits of including regions such as Eastern Europe, Latin America, Asia and India.

Determining Feasibility in Global Clinical Trials was presented by Kent Thoelke, Sr. Vice President, with PRA International and aired on 2007-08-02. This conference is available for download at www.fxconferences.com

eLearning Tune-Up: Small Changes for Big Results

No doubt about it, if you owned an expensive car, you would regularly take it in for a tune-up. Shouldn’t you do the same with your much more costly e-learning systems and programs? Companies everywhere are trying to do more with less. The way to put off major purchases is getting the extra mile out of what you’ve got, spending a little on preventive maintenance and increased performance, rather than a lot on a new vehicle or more options. But where do you start in trying to get more from your existing resources?

In this audio conference we explore the four components of your e-learning that you should look at today: business case and strategy, return on investment (ROI) and return on expectations (ROE), e-learning solution set components and mix of delivery methods, and successful implementation.

eLearning Tune-Up: Small Changes for Big Results is being presented by Lance Dublin, Chief Solutions Architect, with Dublin Consulting and airs on Wednesday, June 24, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Using International English for Better, More Cost-Effective Translations

Doing business on a global scale often means making websites, product materials and other content available to international audiences in their own language. Translation can be a slow and expensive process, especially when taking into account cultural differences that can distort the meaning behind your words. There also can be significant delays and added expense if content is changed during or after translation.

One way to streamline the translation process is through better authoring of source content.. While some have heralded Plain English as the solution, it is not sufficient for some readers, nor is it sufficient for machine translation. This audio conference discusses another option -- international English -- and how it improves clarity for all readers, particularly those who do not read English as a first language. The presentation also highlights how international English gives good results with machine translation, while reducing the costs associated with human translation.

Using International English for Better, More Cost-Effective Translations is being presented by Dr. Mike Unwalla, Principal, with TechScribe and airs on Tuesday, June 9, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

EMEA & Risk Management: What You Need to Know

It is vitally important that pharmaceutical and biotech companies marketing their products in Europe familiarize themselves with what the European Medicines Agency (EMEA) has to say on the subject of risk management. Do you need a risk management plan if you are using centralized procedure? How about decentralized procedure or mutual recognition? Where does risk management go in the dossier? And what sort of risk minimization will be expected?

In this audio conference, EU regulatory expert Dr. Stefan Blesse answers these and more questions about EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use, offering insight and examples as to why it should be considered a strategic opportunity, and not a threat to industry.

EMEA & Risk Management: What You Need to Know is being presented by Dr. Stefan Blesse, Principal Consultant, with Granzer Regulatory Consulting & Services and airs on Thursday, June 4, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Life After Merger: Integrating Teams and Retaining Top Talent

While mergers have a clear strategic value at the enterprise level, they can wreak havoc on the workforce. Employees often imagine the worst merger scenarios. The fear of job loss and reduced status, eroding cultural values and altering established ways of doing business can cause even the most dedicated of employees to become disengaged. This disengagement can turn into either the flight of your top talent, or even worse, quitting mentally but staying on the job.

In this audio conference, Bruce Fern, President and Chief Engagement Solutions Architect at Performance Connections, provides attendees with better ways of keeping the workforce engaged during and after the merger and integration of two potentially very different organizations.

Life After Merger: Integrating Teams and Retaining Top Talent is being presented by Bruce Fern, President and Founder, with Performance Connections International and airs on Tuesday, June 2, 2009. For more details or to register, please visit our site at www.fxconferences.com

Creating and Sustaining Successful Pharma & Biotech Alliance Teams

Alliances in the pharma and biotech industries are on the rise, growing over 80% over the last 10 years. The problem is that as many as 60% to 70% of these alliances underperform or even fail. Yet despite such past performance, most companies expect to continue to form strategic alliances. If alliances remain an inevitable part of corporate strategy, pharma and biotech companies must learn how to create and sustain successful alliances.

Drawing on experience working with such companies as Pfizer, Biogen Idec, Boehringer Ingelheim, and P&G Pharmaceuticals and their alliance teams, Lynda McDermott provides conference attendees with insight into the best practices and relevant tools for launching and developing successful alliance teams.

Creating and Sustaining Successful Pharma & Biotech Alliance Teams is being presented by Lynda McDermott, President, with EquiPro International and airs on Wednesday, May 27, 2009. For more details or to register, please visit our site at www.fxconferences.com

Content Convergence: Making Your Content Work Harder

Organizations invest tremendous amounts of resources on delivering the framework for a great user experience - fabulous website, robust content management infrastructure - yet when it comes to the content itself, there's often a gap. The end result is that the value proposition for customers can't be delivered because the content is insufficient, inadequate, inappropriate and hard to find.

If you're being asked to use your content in more than one way, you might be at the stage where the “more” part includes unfamiliar methods or technologies, syndication or collaborative creation, localization or social media, or communities and user-generated content. This session covers the strategies for delivering the content in ways that meets the user experience needs with sufficient quality to deliver on your brand.

Content Convergence: Making Your Content Work Harder is being presented by Rahel Anne Bailie, Principal, with Intentional Design Inc and airs on Tuesday, May 26, 2009. For more details or to register for this conference, 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 is being presented by Karl Keller, Principal, with Communication Partners and airs on Thursday, May 21, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

The Employee Free Choice Act: What it Means for Employers

If the Employee Free Choice Act passes, it may be the biggest shift in Federal Labor Law since the 1940s, and could severely affect your organization. Employers should understand and be prepared for the movement this Act will create toward a labor organization. This Act will amend the National Labor Relations Act and change the procedures in which employees choose to or not to join a union. Employers should be proactive in learning and creating a good offense to limit labor organizing.

Lisa Anne Friday, a leading expert in the Medical Human Resources field, will give a comprehensive overview of the act, and how it will impact the way you and your company do business. This presentation arms you with a greater understanding of the Employee Free Choice Act and better understand the new climate your organization may be working under, should the Act pass in the first quarter of 2009.

The Employee Free Choice Act: What it Means for Employers was presented by Lisa Anne Friday, Human Resource Division Director, with Community Health Systems. This conference aired on 2009-01-07 and is available for download at www.fxconferences.com

Untapped Clinical Development Opportunity in Latin America

Latin America is among the top emerging regions in the world for clinical research, and provides expanding opportunities for biopharmaceutical product development. The region offers rapid access to patients, lower costs of conducting clinical studies, and availability of highly trained professionals for clinical development. Latin America also offers attractive end markets for biopharmaceutical products.

Currently, more than 80% of the regional market share of pharmaceutical sales and growth is distributed among Argentina, Brazil, and Mexico. However, leading biopharmaceutical companies are starting to uncover new opportunities in other Latin American countries, including Costa Rica, the Dominican Republic, Ecuador, Guatemala, Panama, and Venezuela, that have not been traditionally tapped for clinical development. The speakers will review how to unlock this potential through proper planning and a risk-managed approach.

Drawing on extensive expertise, first-hand knowledge, and experience, these experts discuss how biopharmaceutical companies can achieve clinical trial success for both in-country and international marketing approvals. The speakers discuss the pros and cons of conducting clinical research in "non-traditional" Latin American countries, and provide key risk-based approaches.

Untapped Clinical Development Opportunity in Latin America was presented by Dr. Alberto Grignolo, Diego Glancszpigel & Graciela Racaro, Vice President, General Manager, Vice President, Latin America Operations, Senior Director, Latin America Operations, with PAREXEL. This conference aired on 2008-06-05 and is available for download at www.fxconferences.com

Budgeting for Translations

Do you struggle with budgeting for translations? You’re not alone. Translation used to be an afterthought, a line item tacked onto the bottom of a budget. My, how things have changed... With the flattening world comes an increased need for localized, translated product documentation. In a tough global economy, companies’ upper management are sharpening pencils and paying more attention to translation costs. This means more pressure to find ways to accurately forecast, and budget for, translations.

The trouble is, translation work has many variables that conspire to make budgeting seem like something akin to fortune telling. Project schedules, different language needs and rates, document types and translation memory leveraging are only some of these variables. The key to increasing accuracy in translation budgeting lies in the ability to minimize or lock down the variability to a predictable level.

This audio conference provides an overview of the variables that impact translation budgeting. It offers an insider’s view of how projects are priced at a translation agency and how you can maximize efficiency and work with your providers to keep costs lower and more predictable. Finally, the discussion covers concrete tips on how to create ballpark budgets for your translation projects and extrapolate for quarterly and annual numbers.

Budgeting for Translations was presented by Jason Heaton, with ForeignExchange Translations, and aired on 2009-01-14. To purchase a download of this event, please visit our site at www.fxconferences.com

Medical Device Research and Regulations in Israel

Israel represents the largest single medical device market in the Middle East, valued at roughly 885 million dollars and growing at an annual rate of almost 5%. There is an extensive medical network and high doctor-to-patient ratio, both reflected in a low infant mortality rate and high life expectancy. Distribution of medical conditions and trauma is comparable to the EU and USA.

Israeli schools provide medical professionals with Western-level training, and as a result the country operates on the frontier of medical technology development. With its experienced doctors and high-tech medical facilities, Israel offers medical device companies a regulated, accepting environment in which to conduct clinical studies of the highest quality. Study enrolment is high, as is data quality.

This audio conference provides attendees with information on the regulations governing Israeli clinical studies, and the requirements for placing your medical device on the market in Israel.

Medical Device Research and Regulations in Israel was presented by Efraim Roe Kozorovitsky, Executive Director, Medical Devices, with Premier Research Group. This conference aired on 2009-02-05 and is available at www.fxconferences.com

Predicting and Preventing Protocol Violations

Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.

This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.

Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com

Securing Regulatory Approval for IVDs in China

With a population of 1.2 billion people and growing, China has emerged as a major consumer of healthcare products and one of the most lucrative markets for medical devices and IVD products. Following several years of double-digit growth, recent estimates put the value of the Chinese IVD market in the range of 1.5 billion dollars. However, entering the Chinese market requires no small amount of forethought and planning.

This audio conference discusses the latest organizational chart for the key departments in the SFDA, as announced September 2008, and give insight into hot topics and trends affecting the Chinese healthcare system.

Securing Regulatory Approval for IVDs in China was presented by Janice Ma, Managing Director, ChinaGate and aired on 2009-02-19. This conference is available for download at www.fxconferences.com

Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World

One of the provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) is that the FDA requires manufacturers to submit a Risk Evaluation and Mitigation Strategy (REMS) when a drug or biologic first comes on the market, or later if they become aware of new safety data about the drug. What risk signals should be looked for early in the development process?

In this audio conference we present case studies of various levels of REMS requirements and focus on how to use post-market surveillance requirements to support your product safety profile. Meeting the challenges raised by FDAAA through optimal risk management and utilizing integrated actvities that begin with early clinical testing are key, and must continue throughout the product lifecycle.

Benefits & Risks Throughout the Product Lifecycle: How to Strike a Balance in a Post-FDAAA World is being presented by Dr. Edgar Adams & Robin Carter, Executive Director, Epidemiology & Senior Director, Risk Management Operations, with Covance, and airs on Tuesday, May 5, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Good Reprint Practices: What the FDA Says Now

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker discusses the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

Good Reprint Practices: What the FDA Says Now was presented by Robert J. Klepinski, with Fredrikson & Byron and aired on 2008-09-04, and is available at www.fxconferences.com

Pre-IDE Submissions and Meetings: Best Practices

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this opportunity.

This presentation describes how to optimize the pre-IDE submission of information to FDA, as well as the meeting that follows this submission, in order to maximize the information derived and facilitate your device development plan.

Pre-IDE Submissions and Meetings: Best Practices is being presented by Dr. Elisa Harvey, Senior Regulatory Consultant, with CardioMed Device Consultants and airs on Wednesday, May 20, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Partnering with the New e-Patient for Recruitment Success

The Internet has changed the way people approach their own health care, creating a new breed of engaged, empowered consumer known as the ‘e-patient’. They are taking charge of finding information about their diagnoses and treatment options, and they aren’t shy about interacting online with other patients to exchange experiences and learn more. The most active searchers, according to a groundbreaking white paper by Dr. Tom Ferguson and the e-Patients Scholars Working Group, are acute (newly diagnosed) and chronic patients – arguably, the optimal candidates for clinical trial participation.

This conference profiles the new e-patient, offers strategies for getting his/her attention, and assesses the benefits and challenges of partnering with this population to optimize clinical trial participation.

Partnering with the New e-Patient for Recruitment Success is being presented by Rob Laurens & Matt Stumm, with BBK Worldwide and airs on Thursday, April 23, 2009. For more details, or to signup for this event, please visit our site at www.fxconferences.com

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside

New Chemical Entities (NCEs) that increase the percentage of sustained viral response with current standard treatment for hepatitis C have great marketing potential. Protease inhibitors, polymerase inhibitors, interferons, enzyme inhibitors, viral entry blockers, TLR agonists and oligonucleotides all seek to be included in the future armamentarium. Whether these different classes of compounds can fit together and lead to a successful combination treatment is still unknown. Registration of these NCEs is a long and arduous path, with no guarantee of success.

Drawing on his expertise and 19 years of experience, in this audio conference Dr. van Vliet provides an inside look at opportunities and obstacles when developing a hepatitis C compound, and discusses the critical steps necessary to optimize the chances of the NCE -- condensed Phase I development programs, subsequent proof of concept studies to verify efficacy, and competition for patients versus Phase III trials.

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside is being presented by Dr. Andre van Vliet, Vice President of Medical Affairs, Early Development Services, with PRA International and airs on Tuesday, April 14, 2009. For more details or to register, please visit our site at www.fxconferences.com

Lifecycle Management of the eCTD and NeeS in Europe

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a sponsor file individual submissions or combined submissions for the Reference Member State (RMS) and the Concerned Member States (CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions (NeeS)? What is the time line for all Reference Member States to accept eCTD submissions? In addition to the challenges of choosing the appropriate filing procedure, Sponsor organizations must also understand the concept of life cycle management for the eCTD and NeeS submissions. Unlike FDA, EU has specific requirements for tracking the submission life cycle management approach in Module 1, and the approach for lifecycle management is dependent upon which filing procedure has been selected.

Understanding what information needs to be provided to the RMS and CMS also represents unique challenges for the eCTD life cycle management. For sponsor organizations considering global submissions, the significance of understanding eCTD life cycle management is critical to ensuring a successful and smooth submission process.

Lifecycle Management of the eCTD and NeeS in Europe is being presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs on Tuesday, April 21, 2009. For more details or to register, please visit our site at www.fxconferences.com

Overcoming Challenges in Clinical Cold Chain Transport

Global transport of temperature-sensitive investigational drugs and clinical materials presents a tremendous challenge for pharmaceutical and biotech companies. There are many factors to consider in order to ensure that product integrity remains intact. Successful delivery of investigational drugs from origin to patient is becoming more complicated, especially with increased scrutiny placed on in-transit temperature control and monitoring. As cold chain shipment excursions face increased scrutiny from regulators around the world, it is more important than ever to get it right the first time.

In this audio conference, the speakers review the areas that need to be considered by the clinical development community in order to maximize the performance of their cold chain R&D investments.

Overcoming Challenges in Clinical Cold Chain Transport is being presented by Anthony Leone & Les Sparrow, International Customer Service Manager, Quality Assurance & Technical Support Manager, with World Courier, Inc. and airs on Tuesday, May 12, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com