is being presented by Faiz Kermani, President, of Global Health Education Foundation and airs on Thursday, October 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Emerging markets, such as India, China, Mexico and Brazil have experienced a surge in popularity as locations for outsourced clinical research. A wider availability of patients, low operational costs, and positive patient attitudes towards clinical trials have driven this trend. This has further significance given that these emerging regions are also becoming important markets for new products.
However, in expanding clinical research to these regions, sponsors must be careful not to overlook linguistic and cultural differences among the various patient populations. Language and culture are also important factors in dealing with local regulatory authorities and governmental agencies. It is also imperative that sponsors understand that by extending their reach to emerging regions, there are difficult questions to answer in how best to involve subjects in clinical trials and yet not be seen to be exploiting them. This presentation will summarize key linguistic and cultural themes impacting global clinical research, and suggest best practices for leveraging the opportunities of emerging markets while avoiding the pitfalls.
Showing posts with label Clinical research. Show all posts
Showing posts with label Clinical research. Show all posts
Friday, September 30, 2011
Tuesday, March 8, 2011
The Continuing Evolution of Clinical Research in India
is being presented by Dr. Vijai Kumar & Dan McDonald, President/Chief Medical Officer & Vice President Business Strategy, with Excel Life Sciences and airs on Tuesday, April 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.
Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.
The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.
Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.
Wednesday, February 16, 2011
Drivers and Risks of Off-shoring Clinical Data Management
is being presented by Dr. Johann Proeve, Head of Global Data Management, with Bayer Healthcare and airs on Thursday, March 24th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Off-shoring of certain activities related to the management of clinical trials has become commonplace in the pharmaceutical and biotechnology industry, and one of the functions most affected has been clinical data management (CDM). The main contributors for off-shoring CDM are the fixed costs, lower salaries in low-cost countries and CDM being viewed as a non-core competency in the industry.
But is off-shoring really the easy solution it might appear to be when faced with the rising cost of conducting clinical research? Certainly, off-shoring of CDM is associated with certain risks, including high staff turnover, required overhead for the management of the processes, availability of knowledgeable staff for health authority inspections and the eventual erosion of the cost advantage compared to Western countries.
This audio conference addresses the main drivers and risks associated with the off-shoring of CDM, and looks at the various ways in which CDM can contribute and thereby justify its existence.
Off-shoring of certain activities related to the management of clinical trials has become commonplace in the pharmaceutical and biotechnology industry, and one of the functions most affected has been clinical data management (CDM). The main contributors for off-shoring CDM are the fixed costs, lower salaries in low-cost countries and CDM being viewed as a non-core competency in the industry.
But is off-shoring really the easy solution it might appear to be when faced with the rising cost of conducting clinical research? Certainly, off-shoring of CDM is associated with certain risks, including high staff turnover, required overhead for the management of the processes, availability of knowledgeable staff for health authority inspections and the eventual erosion of the cost advantage compared to Western countries.
This audio conference addresses the main drivers and risks associated with the off-shoring of CDM, and looks at the various ways in which CDM can contribute and thereby justify its existence.
Friday, February 4, 2011
Understanding Clinical Data Management Standards
is being presented by Jonathan Andrus & Jennifer Price, Vice President, Data Management and Quality & Director, Clinical Solutions, of BioClinica and airs on Tuesday, March 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
Monday, January 17, 2011
FDA Guidance on Clinical Investigator Roles and Responsibilities
is being presented by Dr. Anita S. Kablinger, Virginia Tech Carilion School of Medicine and airs on February 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Clinical researchers face a steep learning curve. The importance of research, as well as the practice of participation in research, remains a relatively minor component of medical school and graduate medical education. Clinical investigators often have limited knowledge of the FDA rules and regulations in drug development other aspects of clinical research.
This presentation reviews the FDA guidance concerning what the clinical investigator – as well as those seeking qualified investigators – needs to know and demonstrate to provide academic rigor, maintain the highest safety standards of participants and promote the development of novel compounds and devices.
Clinical researchers face a steep learning curve. The importance of research, as well as the practice of participation in research, remains a relatively minor component of medical school and graduate medical education. Clinical investigators often have limited knowledge of the FDA rules and regulations in drug development other aspects of clinical research.
This presentation reviews the FDA guidance concerning what the clinical investigator – as well as those seeking qualified investigators – needs to know and demonstrate to provide academic rigor, maintain the highest safety standards of participants and promote the development of novel compounds and devices.
Monday, December 6, 2010
Enhanced Monitoring Tools and Strategies to Optimize Productivity and Compliance
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Tuesday, January 11th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Wednesday, September 29, 2010
Improving Data Manager and CRA Collaboration in an eClinical Environment
is being presented by Jonathan Andrus, Vice President, Data and Study Operations, eClinical Division, with BioClinica and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Clinical research professionals from the data management and clinical monitoring arenas don't always collaborate to the extent they should, and as a result miss out on opportunities to reduce “toe stepping” and data quality issues and to forge a better, more productive working relationship. This presentation focuses on steps that can be taken together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked.
Bringing together the data management and clinical monitoring groups early on in the study design and development and user acceptance process are some examples of how these groups can help ensure that varied and divergent ideas can be aligned for a better developed study database. However, beyond initial study design, the presentation addresses topics related to collaborative data review and cleaning during the conduct phase of the study. During study closeout, the successful lock of the database hinges on the close working relationship of the clinical field staff and the in-house data management staff. This presentation looks at how to make the study closeout process more effective, less time consuming, less redundant and more meaningful.
Clinical research professionals from the data management and clinical monitoring arenas don't always collaborate to the extent they should, and as a result miss out on opportunities to reduce “toe stepping” and data quality issues and to forge a better, more productive working relationship. This presentation focuses on steps that can be taken together to improve data quality and increase the speed and quality by which study databases can be reviewed, cleaned and locked.
Bringing together the data management and clinical monitoring groups early on in the study design and development and user acceptance process are some examples of how these groups can help ensure that varied and divergent ideas can be aligned for a better developed study database. However, beyond initial study design, the presentation addresses topics related to collaborative data review and cleaning during the conduct phase of the study. During study closeout, the successful lock of the database hinges on the close working relationship of the clinical field staff and the in-house data management staff. This presentation looks at how to make the study closeout process more effective, less time consuming, less redundant and more meaningful.
Wednesday, February 17, 2010
Comparative Costs of Clinical Development in CEE and Other Regions
is being presented by Dr. Malgorzata Szerszeniewska, CEO, of Easthorn Clinical Services in CEE and airs on Wednesday, March 24, 2010. For more details or to register, please visit our site at www.fxconferences.com
It has recently been shown that the cost of clinical trials may play a crucial role in the drug development process. A lot of the most innovative biotech companies struggled financially last year and many programs have been put on hold or cancelled due to cash flow problems. A lot of companies have had difficulties in finding partners to help them financially to complete even very promising programs. That is why the cost of conducting clinical trials has become one of the major factors for pharma companies’ drug development strategies, their pipelines, and their CRO selection criteria. As market volume shrank CROs had to compete for fewer studies and price has become an important selection criterion.
This presentation provides a comparison of clinical trial costs in central and eastern europe and other representative regions. Our speaker addresses a variety of factors influencing the costs and discusses the dynamics and directions of recent changes. This information is of use in future budget planning, strategic country selection for specific clinical trials and minimizing financial surprises while running trials in CEE.
It has recently been shown that the cost of clinical trials may play a crucial role in the drug development process. A lot of the most innovative biotech companies struggled financially last year and many programs have been put on hold or cancelled due to cash flow problems. A lot of companies have had difficulties in finding partners to help them financially to complete even very promising programs. That is why the cost of conducting clinical trials has become one of the major factors for pharma companies’ drug development strategies, their pipelines, and their CRO selection criteria. As market volume shrank CROs had to compete for fewer studies and price has become an important selection criterion.
This presentation provides a comparison of clinical trial costs in central and eastern europe and other representative regions. Our speaker addresses a variety of factors influencing the costs and discusses the dynamics and directions of recent changes. This information is of use in future budget planning, strategic country selection for specific clinical trials and minimizing financial surprises while running trials in CEE.
Monday, February 8, 2010
Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting
While considered a relatively novel term in research, biomarkers and diagnostics have been extensively used in the pre-clinical and clinical research and diagnosis arena for many years. Their magnitude in positively influencing the medical community’s ability to accurately diagnose and treat human conditions, although still undefined, seems limitless. Currently, a renewed focus is being placed on healthcare outcomes, and the containment of medical cost, diagnostics, biomarkers and personalized medicine are fostering better outcomes and savings.
In this Webinar, our speakers discuss how the need for more clinical applications for diagnostic biomarker testing is expected to have an explosive growth among several disease categories in the five years. They also explain how the operational execution of biomarker and diagnostic research varies greatly from traditional clinical research, while looking at the unique requirements and challenges.
Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting is being presented by Dr. Jerome Wilson & Kathleen Kushner, Sr. Scientific Affairs Director & Scientific Affairs Director, Late Phase Services, with PRA International and airs on Tuesday, February 23, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
In this Webinar, our speakers discuss how the need for more clinical applications for diagnostic biomarker testing is expected to have an explosive growth among several disease categories in the five years. They also explain how the operational execution of biomarker and diagnostic research varies greatly from traditional clinical research, while looking at the unique requirements and challenges.
Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting is being presented by Dr. Jerome Wilson & Kathleen Kushner, Sr. Scientific Affairs Director & Scientific Affairs Director, Late Phase Services, with PRA International and airs on Tuesday, February 23, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Tuesday, November 24, 2009
Conducting Drug Trials in Central & Eastern Europe
Over the next several months, ForeignExchange will present a series of audio conferences featuring expert speakers from Covance discussing the key benefits and drawbacks of using non-traditional sites for conducting clinical research.
In this first first presentation, we focus on the opportunities present in Central and Eastern Europe. This presentation will highlight the current status of the health care system in this region, and how it creates a propitious environment for clinical research business development, boasting rapid recruitment and high quality data.
Conducting Drug Trials in Central & Eastern Europe was presented by Dr. Malgorzata Szerszeniewska, Director of Strategic Development, Central & Eastern Europe, with Covance and is previously recorded. To download this event, or for more details please visit our site at www.fxconferences.com
In this first first presentation, we focus on the opportunities present in Central and Eastern Europe. This presentation will highlight the current status of the health care system in this region, and how it creates a propitious environment for clinical research business development, boasting rapid recruitment and high quality data.
Conducting Drug Trials in Central & Eastern Europe was presented by Dr. Malgorzata Szerszeniewska, Director of Strategic Development, Central & Eastern Europe, with Covance and is previously recorded. To download this event, or for more details please visit our site at www.fxconferences.com
Tuesday, November 3, 2009
Clinical Trial Success in Latin America
Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.
This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.
Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, please visit our site at www.fxconferences.com
This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.
Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, please visit our site at www.fxconferences.com
Tuesday, September 29, 2009
Optimizing Country Selection for Clinical Research
A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.
In this presentation, Dr. Stansfield discusses these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She also highlights the pros and cons of different approaches.
Optimizing Country Selection for Clinical Research was presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, with PRA International and aired on 2008-02-14. For more details, or to download this conference please visit our site at www.fxconferences.com
In this presentation, Dr. Stansfield discusses these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She also highlights the pros and cons of different approaches.
Optimizing Country Selection for Clinical Research was presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, with PRA International and aired on 2008-02-14. For more details, or to download this conference please visit our site at www.fxconferences.com
Monday, August 10, 2009
From Emerging to Emerged: Clinical Development in Asia Pacific
Although in the past Asia Pacific was deemed an emerging region for clinical research, it has now evolved and emerged, catching the interest of global pharmaceutical and biotech companies. Good Clinical Practice (GCP) was adopted as a local regulatory requirement in most of these counties in the late 1990s. Since then, industry-funded clinical research has grown rapidly in the eleven countries that are routinely considered for global IND studies.
The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.
This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.
From Emerging to Emerged: Clinical Development in Asia Pacific is being presented by Edward C. Ian, Senior Director of Clinical Operations, Asia Pacific, with PRA International and airs on Wednesday, September 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com
The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.
This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.
From Emerging to Emerged: Clinical Development in Asia Pacific is being presented by Edward C. Ian, Senior Director of Clinical Operations, Asia Pacific, with PRA International and airs on Wednesday, September 2, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com
Wednesday, August 5, 2009
Alternative Site Selection: China
This is one of two Covance audio conferences dealing with alternative site selection (the other event covers Latin America), and focuses on opportunities for the conduct of clinical research in China. This presentation provides an overview of the current clinical research environment in China and explores reasons why China should be considered as part of global drug development strategies.
Alternative Site Selection: China was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and is previously recorded. For more details or to download this conference, please visit our site at www.fxconferences.com
Alternative Site Selection: China was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and is previously recorded. For more details or to download this conference, please visit our site at www.fxconferences.com
Thursday, February 26, 2009
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
To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com
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
To learn more about Korean translations, please visit ForeignExchange Translations website at www.fxtrans.com
Wednesday, February 25, 2009
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
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
Monday, January 19, 2009
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.
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.
Friday, September 5, 2008
Adaptive Trial Design: Streamlining the Clinical Supply Process
Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.
From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).
Adaptive Trial Design: Streamlining the Clinical Supply Process is presented by Geert Langendries, Covance IVRS Project Management Group. This audio conference was recorded on 2007-12-05 and is now available for download at www.fxconferences.com
From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).
Adaptive Trial Design: Streamlining the Clinical Supply Process is presented by Geert Langendries, Covance IVRS Project Management Group. This audio conference was recorded on 2007-12-05 and is now available for download at www.fxconferences.com
Tuesday, August 26, 2008
Adapting Patient Recruitment to Global Cultures
Patient recruitment is often mistakenly equated with advertising, when in actuality it is a considered collection of practices in response to a problem or a set of risks. The discipline is still new to many world regions outside of North America, presenting challenges both in acceptance and in practice among study professionals globally.
This audio conference will focus on overcoming those challenges in order to successfully conduct patient recruitment globally using the most appropriate, effective, and ethically acceptable tactics. In addition, it will also illustrate methods for culturally adapting patient recruitment practices - particularly creating patient communications (including advertising) - to resonate with target populations in each country.
Adapting Patient Recruitment to Global Cultures is presented by Rob Laurens, Leader, Creative Services & Matt Stumm, Senior Art Director, of BBK Healthcare. This audio conference was previously recorded on 2008-01-23 and is now available for download at www.fxconferences.com.
This audio conference will focus on overcoming those challenges in order to successfully conduct patient recruitment globally using the most appropriate, effective, and ethically acceptable tactics. In addition, it will also illustrate methods for culturally adapting patient recruitment practices - particularly creating patient communications (including advertising) - to resonate with target populations in each country.
Adapting Patient Recruitment to Global Cultures is presented by Rob Laurens, Leader, Creative Services & Matt Stumm, Senior Art Director, of BBK Healthcare. This audio conference was previously recorded on 2008-01-23 and is now available for download at www.fxconferences.com.
Wednesday, August 20, 2008
Medical Device Clinical Evaluations: EU vs. US
In this presentation, Dr. Colquhoun explains the circumstances in which medical device manufacturers need to generate de novo clinical data. The audio conference also looks at the different types of clinical evaluations and the importance of conducting them in the EU (and USA).
The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.
The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.
This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.
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