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 23rd, 2008. For more details please visit our site www.fxconferences.com

Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented on 2007-06-28 and is available for download at www.fxconferences.com

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Leveraging Technology for Conducting More Efficient Trials in India

Compelling fundamentals are driving the growth factor of the clinical development sector in India. There is potential for innovation and sector transformation if technologies, processes and workflow can be leveraged to select quality sites that have the subject populations to meet enrollment goals and efficiently manage your clinical trial projects while enhancing the quality, regulatory and ethics training of clinical site research personnel. Are your clinical trial management processes well-suited for this clinical trials landscape? Increasing efficiency with costing and timelines is crucial to a successful trial, and there are an array of technologies available to help you achieve your clinical trial goals.

This audio conference will provide insights on technology, process and procedures to effectively manage clinical trials in India. You will be armed with the most efficient technology-based solutions mapped with workflow processes for continued success in the Indian pharmaceutical marketplace.

Leveraging Technology for Conducting More Efficient Trials in India is being presented on Wednesday, March 18th, 2009. For more details, please visit our site www.fxconferences.com

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation focuses on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

Meeting the Challenges of Global Oncology Trials was presented by Dr. Ute Berger, Senior Director of Therapeutic Expertise Oncology & Hematology, with PRA International and is available for download at www.fxconferences.com

Regulation vs. Communication: Finding the Balance

It's no wonder pharmaceutical companies are hyper-focused on regulatory compliance. For the first time ever, a physician was indicted for off-label promotion (Xyrem, Gleason; case pending). Over the past two years, off-label promotion fines increased from $3 to $5 billion. Even company executives have been personally fined (Purdue Frederick, guilty plea, $38M).

At the same time, the need to reduce the morbidity and mortality associated with chronic disease has driven investment in consumer and patient education about illness and drug treatment. Spending on DTC advertising increased by 330% from 1996 to 2005 (NEJM). Spending on eMarketing/promotion will reach over $480m by 2011 (Visiongain).

It's a double-edged sword. Companies cannot afford to pay the price for noncompliance (e.g. legal fees, criminal prosecution, corporate integrity agreements, and negative media attention). Yet, to maximize health outcomes, marketing communications must ensure that the messages break through at a time and place where patients can hear them. Prime example: social networking, which has opened the door for more participation and spontaneous emotion. How does the industry stay compliant and be creative at the same time? In the end, we owe it to ourselves, our associates and our organizations to deliver on this goal within an ever more restricted regulatory environment.

Regulation vs. Communication: Finding the Balance was presented by Ilyssa Levins, President, with HCIL Consulting and aired on 2008-01-10. For more details or to purchase a download of this event, please visit our site www.fxconferences.com

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs

Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs is being presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Wednesday, February 25th, 2009. For more details or to register, please visit our site at www.fxconferences.com

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies

Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference will provide insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies is being presented by Yvonne Albright and Barbara Vargas, Project Managers, with Covance Periapproval Services and airs on Wednesday, March 11th, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

European Data Privacy: Are you compliant?

This audio conference will provide an overview of the importance of data privacy in Europe for companies operating internationally and using a global HRIS application. Are you compliant? Do you have the appropriate policies in place to secure personal and sensitive data about your employees, contractors, customers and suppliers? What do you need to pay attention to?

European Data Privacy: Are you compliant? is being presented by Pascale Viret, Director of Human Resources, EMEA, with Haemonetics Corporation and airs on Wednesday, March 4th, 2009. For more details, please visit our site www.fxconferences.com

Industry Update: EU Labeling for Medical Devices

Many companies believe that by simply having the CE mark on their products, they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this audio conference, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition the presentation covers proper language for the intended users in conjunction with risk management.

Industry Update: EU Labeling for Medical Devices is being presented by Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and airs on Thursday, March 12th, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

Risk-Based Software Validation for Medical Devices

It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent. Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development, medical device companies also need to be looking for new and improved ways to validate that software.

In this audio conference we examine the various approaches to software validation, and discuss how and why to consider risk as part of the validation process. The presentation also looks at ANSI/AAMI/IEC 62304:2006 Medical Device Software - Software Lifecycle Processes, and how it uses risk to drive software verification and validation.

Risk-Based Software Validation for Medical Devices is being presented by Bob Barrett, Systems Engineering Lead, with Intertech Engineering Associates, Inc. and airs on Wednesday, April 22nd, 2009. To register, or for more details please visit our site www.fxconferences.com

Improving the Readability of Your Patient Information

Life sciences companies go to great lengths to provide patients and users with all the information they need to use products safely and effectively. But how do you ensure those patients understand what you are telling them? According to the Institute of Medicine, nearly half of the adult population in the United States may lack the skills needed to function within the healthcare system. The FDA says patient materials should be written at a 6th to 8th grade reading level, while recently revised European Commission guidelines call for "well designed and clearly worded" package inserts.

In this presentation, the speaker provides attendees with the tools to overcome some of the challenges encountered when communicating written health care information. The presentation includes a brief overview of health literacy in the U.S., and discusses how plain language, organization and format can all be used to create PPIs, medication guides, marketing collateral and patient education materials that conform to current regulatory guidelines.

Improving the Readability of Your Patient Information is being presented by Jennifer Hicks, President, with WordsWork Consulting, Inc. and airs on Thursday, March 26th, 2009. For more details, please visit our site at www.fxconferences.com

Essential Leadership Skills to Turbocharge R&D Teams

Pharmaceutical/biotechnology R&D is a complex, multi-functional and highly integrated discipline. Sound leadership practices are central to developing highly committed teams that will efficiently produce quality information in a timely fashion. Teams committed to exceptional service and performance result in faster application submission and approval, enhanced creativity that generates new product concepts, increased profitability by producing efficiencies that reduce cost, and enhanced investor confidence.

In this audio conference we explore the basis of achieving exceptional performance; how commitment is obtained; a review of essential leadership and communication skills; personal leadership practices; consideration of team structure; the development of a service culture and how it can be leveraged to produce efficiencies, reduce cost and enhance creativity; and understanding the customer, both internal and external.

Essential Leadership Skills to Turbocharge R&D Teams is being presented by Dr. Arthur Kamm, Founder, with Pharmaceutical Growth Services and airs on Wednesday, April 15th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

A Practical Guide to Hazard Analysis for Medical Devices

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

A Practical Guide to Hazard Analysis for Medical Devices is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.

Registering Device Trials on ClinicalTrials.gov

It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov. Along with mandating the inclusion of medical device trials, additional requirements included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.

One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.

In this audio conference, you learn the latest information on registration of medical device trials and what you must do for compliance.

Registering Device Trials on ClinicalTrials.gov was presented on 2008-11-13 and is available for download at www.fxconferences.com

Industry Update: Vigilance for Medical Devices

After a few quiet years, several important European regulatory changes have occurred that will affect most medical device manufacturers. Most notably, Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared.

In this presentation, Dr. Loh discusses important new revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, published in April 2007. The guidelines entered into force on January 1st, 2008.

Industry Update: Vigilance for Medical Devices was presented on 2007-06-21 and is available to download to www.fxconferences.com

Leveraging the Benefits of eMDR (Electronic Medical Device Reporting)

Inefficient medical device reporting presents a clear and present danger: It can damage your company’s reputation and even threaten your ability to operate. After sending some mixed signals in the second half of 2007, FDA eMDR experts have said they’ll mandate eMDR within two years. The only debate now is how quickly it will happen, and what kind of timeline mandate will be imposed.

It’s therefore not surprising to learn the agency is pushing harder for electronic medical device reporting than anyone else. By attending this audio conference, you'll learn more about the future of eMDR, the options available to you now, and why it makes good business sense to implement an electronic medical device reporting system today.

Leveraging the Benefits of eMDR (Electronic Medical Device Reporting) was presented on 2008-12-10 and is available to download at www.fxconferences.com

Getting Along Famously: Creating Harmony in Project Teams

Cutbacks! Layoffs! Budget reductions! Like many industries, it feels like the life sciences are under seige these days. In this workplace environment, managing teams is not good enough, muddling through is not an option. Today’s teams are being asked to do more with less, overcome functional and cultural differences and devise domestic and global solutions. With these weighty agendas, R&D teams have no time for less than the highest level of performance at every team meeting, making quality decisions, meeting deadlines and sticking to a tight budget.

In this audio conference, our speaker shares expert advice on how R&D teams can get along famously, moving from discordant, wasteful, dysfunctional teams to harmonious, functioning teams through a set of “people science” solutions.

Getting Along Famously: Creating Harmony in Project Teams is being presented by Susan Morris, President, Morris Consulting Group, LLC and airs on Tuesday, March 3rd, 2009. For more details or to register for this conference, please visit our site 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 on 2008-12-03 and is available for download at www.fxconferences.com