Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971.

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 aired on 2008-02-21 and is available for download at www.fxconferences.com

Complying with EU Antitrust Laws

It is 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 will also discuss when you should seek legal assistance, and how to behave in the event of dawn raids.

Complying with EU Antitrust Laws is being presented by Marc Besen & Dr. Christian Mayer, Partner & Associate, Clifford Chance and airs on Tuesday, March 10th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Dealing with Conflict of Interest in Troubled Economic Times

We need look no further than the morning paper to see charges or allegations of conflict of interest involving high-profile people and organizations. However, the fact of the matter is that in the business world, situations arise almost every day where there exists the potential for conflict. How best to handle them?

In this audio conference, our speakers will help the audience understand and adjust to changing standards regarding ethical business behavior and potential conflicts of interest. The presentation will discuss both the visible and less-than-visible types of conflicts of interest that business people confront in their roles as executives, directors, advocates and advisors. Using examples torn from recent headlines, the speakers will illustrate methods of coping with those conflicts, and explain the importance of developing a personal and professional code of ethics. They will also discuss some recent and ongoing academic research on governance and ethics, and explore both domestic and international efforts to cope with conflicts.

Dealing with Conflict of Interest in Troubled Economic Times is being presented by Michael Martorelli & Patricia Connolly, Director, Fairmount Partners & Managing Director, LeBow College of Business and airs on Thursday, March 5th, 2009. For more details or to register, please visit our site www.fxconferences.com

Managing Global Market Research for Consistency and Insight

Medical companies are increasingly sponsoring global research projects – but is this research effective? How can cultural and linguistic differences be managed to ensure the integrity of the result? Are differences between cultures just skin deep or do they extend to personality? How can we create research metrics that will have consistent meaning around the world? In this Webinar we will provide understanding of these issues and tools for managing global research projects.

Managing Global Market Research for Consistency and Insight was presented by Peter Simpson, President, with Segmedica and aired on 2008-11-12. For more details or to purchase the recording of this event, please visit our site www.fxconferences.com

The Pre-IND Program: 12 Steps to a Successful IND Filing

The Pre-IND phase of drug development is the foundation upon which all subsequent IND research depends, in order to obtain FDA market approval (NDA) after completion of required Phase 1-3 trials. Therefore, it is essential to give proper forethought and attention to these first, all-important steps. This audio conference looks at the 12 essential steps to complete during the Pre-IND phase of development leading to the filing of an original IND with the goal of obtaining FDA approval for initial Phase 1 clinical trials.

Our speaker, veteran industry expert Dr. Larry Hofmann, will give expert guidance on the optimum background and make-up of your pre-IND development team. He will also discuss strategic planning for and preparation of the FDA meeting information package -- provided to the FDA reviewing division 30 days prior to the pre-IND meeting -- which must include available pharmacology and toxicology summaries, as well as a summary of CMC data on the IND clinical formulation to support the proposed Phase 1 and Phase 2a study protocols.

The Pre-IND Program: 12 Steps to a Successful IND Filing is being presented by Dr. Larry Hofmann, President, with LMH Associates, Inc. and airs on Tuesday, March 31th, 2009. For more details or to register for this event, please visit our site at 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.

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 will discuss 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 is being presented by Janice Ma, Managing Director, with ChinaGate and airs on Thursday, February 19th, 2009. For more details or to register for this conference, 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.

Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition?

IEC 60601-1 is the cornerstone standard for medical electrical devices, yet development and adoption of the latest edition has been a long, complicated process. Three years after publication, there is still mass confusion over the ever-changing international and regulatory requirements impacted by the 3rd edition of IEC 60601-1. What is the best strategy for your company when it comes to designing your product to IEC 60601-1? Should you design to 2nd or 3rd edition, or both? The answer depends on where and when you will be selling your product!

In this audio conference, Leo Eisner provides a status update on IEC 60601-1 3rd edition, and discusses planned revisions, important regulatory dates related to the standard, and how the collateral and particular standards are aligned to 3rd edition. There are major changes from the 2nd edition, changes you need to know about in order to comply. Get the answers to your 60601-1 compliance questions from a leading expert!

Industry Update: Where Do We Stand With IEC 60601-1 3rd Edition? is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Tuesday, February 10th, 2009. For more details or to register for this conference, please visit our site at 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.

Global Patent Standards

Is your patent adequately protected in all of the markets where you do business? Are you sure about that?

In many industries, patent protection in both the United States and abroad is critical, but the requirements for each country are not necessarily the same. Thus, in developing a patent strategy, the different requirements of countries where protection is desired must be considered prior to filing.

In this audio conference, we review the various global patent standards in countries where patent protection is typically sought. Particular emphasis will be placed on written description requirements, obviousness and inventive step standards in the United States and in Europe.

Global Patent Standards is being presented by Christopher Rhodes, PhD, Intellectual Property Attorney, with Lowrie Lando & Anastasi LLP and airs Tuesday, March 24, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

FCPA Compliance Strategies for Medical Device & Pharma Companies

The Foreign Corrupt Practices Act (FCPA) has had a major impact on the way companies conduct business abroad. A U.S. anti-corruption law jointly enforced by the Department of Justice and the Securities and Exchange Commission, its main provisions deal with improper payments to foreign officials and questionable accounting practices used to hide them. Violating the FCPA can result in both criminal and civil penalties, and the requirements are complex, applying to both companies in the U.S. and foreign-based companies subject to U.S. securities laws. Past enforcement actions have crossed industry boundaries and included the pharmaceutical industry. Lately, there has been an increase in FCPA enforcement activity in the medical device industry as well.

In this audio conference, our speakers combine their experience with real-world case studies to provide a clear background on the FCPA requirements and enforcement trends, along with practical compliance strategies to keep device and pharma companies from running afoul of the law.

FCPA Compliance Strategies for Medical Device & Pharma Companies is being presented by Bethany Hills & Michelle Merola, with Hodgson Russ LLP and airs Wednesday, April 1, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision. This audio conference will focus on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation will review the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants will also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker will also provide attendees with an essential clinical investigation document checklist.

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 is being presented by Carol Houts, Director of Regulatory, Quality & Safety, with Pleiad, Inc. and airs on Thursday, February 26th, 2009. For more details or to register 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.

Proteomics Role in Biomarker Discovery and Validation

Regulatory agencies continue to support the use of biomarkers and encourage biotech and pharmaceutical companies to have a biomarker strategy for all compounds. Biomarkers can play a significant role in identifying signal in early compound candidates as well as clinical targeting and stratification of efficacious populations.

We’ll examine proteomics role in the identification of novel protein biomarkers and subsequent high-throughput assay development and validation that can significantly reduce risk and enhance clinical development productivity and decision making in Pharmaceutical research.

Proteomics Role in Biomarker Discovery and Validation is being presented by Dr. Daniel Chelsky, Chief Scientific Officer with Caprion Proteomics and airs on Wednesday, February 11th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - part 1 and 2) is currently under revision. This audio conference will focus on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. The presentation will review the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants will also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Part 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker will also provide attendees with an essential clinical investigation document checklist.

GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 is being presented by Carol Houts, Director of Regulatory, Quality & Safety, with Pleiad, Inc. and airs on Thursday, February 26th, 2009. For more details or to register please visit our site www.fxconferences.com

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

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference will discuss the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study is being presented by Michael Rosenberg, M.D., Ph.D, CEO, with Health Decisions and airs on Wednesday, February 18th, 2009. For more details, or to register please visit our site www.fxconferences.com

Medical Translation Blog

To kick off the new year, we have launched the Medical Translation Blog. As we have done with our newsletters and published articles, the content will revolve around issues impacting medical translation professionals: Regulatory news such as the pending Asian Medical Device Directive, technology news (from machine translation to personal efficiency tools) and language developments like the current Brazilian Portuguese spelling reform.

Medical translation buyers and service providers of all types will like the daily updates. You can stay up-to-date by subscribing to email updates or read our feed with your favorite RSS reader. And you are invited to participate in discussions or by providing tips to developing news.

Whether you participate actively or just read the posts, we hope that you will subscribe to the new Medical Translation Blog!

Successful Medical Device Approvals in China

With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving. In this audio conference, our speaker discusses the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation also provides examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.

Successful Medical Device Approvals in China was presented by Janice Ma, Managing Director, with ChinaGate and aired June 19th, 2008. For more details, or to listen to a sample clip, please visit our site 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 aired on 2007-08-02 and was presented by Kent Thoelke, Sr. Vice President, with PRA International. For more details please visit our site 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 is being presented by Bruce D. Sunstein, Co-founder and Partner, with Bromberg & Sunstein LLP and airs on Thursday, February 12, 2009. For more details on this conference or to register, please visit our site www.fxconferences.com

Global Regulatory Teamwork Strategies

Are you in the process of putting together a team to take your products or services global? Unsure where to begin? Global teams have become the norm in the life sciences industries. When they work well, these teams can bring new products to markets all around the world in record time. But when they don't work well, global teams can end up operating as a collection of national sub-teams that ignore or even compete with one another.

How do you build effective, cohesive global teams in the device, diagnostics or pharmaceutical industries, while avoiding the costly mistakes that can lead to dysfunction -- or worse! Join us and get the answers you need!

Global Regulatory Teamwork Strategies was presented by Dr. Lionel Laroche, Executive Vice President, with CPI Hazell & Associates and is available for download at www.fxconferences.com

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message was presented by Nancy Hoft, of Nancy Hoft Consulting and aired 2008-07-16. For more information or to purchase a download of this event, please visit our site 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 purchase a download, please visit our site www.fxconferences.com