is being presented by Herb Cohen, Senior Managing Partner, with Performance Connections International, Inc. and airs on Wednesday, September 29th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Successful scientists, engineers and IT professionals realize the importance of developing ongoing and productive “win-win” relationships with others outside their own department. Especially when resources are stretched, influencing and negotiating with coworkers in different areas of the company to gain their time and commitment to meet your needs is critical to the success of your business.
When your goal is to influence coworkers, you often face unique challenges and issues. While you and your coworkers all support the greater needs of the company, understanding each other’s individual and departmental issues is important in getting results. This isn’t always simple to do, and, in fact, can become even more complicated when you must make your case to a group, rather than to an individual.
This audio conference discusses how the genetic wiring of most technical professionals is different than other occupational groups. Speaker Herb Cohen explains how to resolve issues in a positive way that maintains the internal customer relationship, and shares top strategies that are mutually beneficial to everyone and that will benefit you and your company in both the short and long term.
Tuesday, August 31, 2010
Friday, August 27, 2010
Comparative Effectiveness Research: Threat or Opportunity?
is being presented by Dr. Edward E. Berger, Principal and Founder, of Larchmont Strategic Advisors and airs on Wednesday, September 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.
This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.
Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.
This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.
Wednesday, August 25, 2010
Sustainability: The Business Case and Beyond
is being presented by Federico Fische, Renewable Energy Consultant and airs on Wednesday, November 17th, 2010. For more details or to register, please visit our site at www.fxconferences.com
We are constantly being bombarded by terms like green, sustainable, and social responsibility. Corporations, state and municipal officials and consumers are being urged to reduce their “carbon footprint” and to become more “green” and “sustainable.”
Both the public and private sector are engaged in parallel decision-making processes addressing the environment and the sustainability of the society as a whole. These decisions will affect the way corporations and government work, and the shape of the business environment. Changes in consumer behavior will affect how corporations and government will deliver their goods and services. The goal is to raise the level of debate on climate change and the environment, and promote an understanding of what government officials at the federal, state and municipal level are trying to say and do. This audio conference looks at the concepts behind the trendy buzzwords, and examines both the social and business case for 'going green'.
We are constantly being bombarded by terms like green, sustainable, and social responsibility. Corporations, state and municipal officials and consumers are being urged to reduce their “carbon footprint” and to become more “green” and “sustainable.”
Both the public and private sector are engaged in parallel decision-making processes addressing the environment and the sustainability of the society as a whole. These decisions will affect the way corporations and government work, and the shape of the business environment. Changes in consumer behavior will affect how corporations and government will deliver their goods and services. The goal is to raise the level of debate on climate change and the environment, and promote an understanding of what government officials at the federal, state and municipal level are trying to say and do. This audio conference looks at the concepts behind the trendy buzzwords, and examines both the social and business case for 'going green'.
Tuesday, August 24, 2010
Budgeting for Translations
is being presented by Jason Heaton, of ForeignExchange Translations and airs on Wednesday, September 29th, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
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.
Monday, August 23, 2010
CGMP Guidance for Phase 1 Clinical Supplies
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
Friday, August 20, 2010
Human Factors Requirements and Usability Testing for Medical Devices
is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, September 16th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation reviews several guidance documents issued by FDA regarding its human factors initiative. The speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Wednesday, August 18, 2010
The Virtual CRO: Future of Drug Development Partnerships?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Thursday, September 30th, 2010. For more details or to register, please visit our site at www.fxconferences.com
The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.
But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.
The virtual contract research organization, or vCRO, is a relatively new concept in the world of drug development. It is a business model based entirely on strategic outsourcing, and companies that boast little or nothing in the way of brick-and-mortar facilities. As a result, these companies also have minimal overhead where staffing and facilities are concerned, and can pass those savings on to sponsors. In a world where drug development costs are skyrocketing, and at a time when working with traditional CROs has become a chronic pain point for many sponsors, there are those who predict this model will change the face of the industry.
But is the virtual CRO all it appears to be? Is it the right choice for all sponsors and all aspects of clinical research? What about laboratory testing or seeing patients at the site? This audio conference takes a critical look at the vCRO model, and discusses where and when it might be an appropriate option for sponsors, and conversely, situations where the traditional model might be a better choice.
Tuesday, August 17, 2010
Strategic Portfolio Management for Medical Devices
is being presented by Bill Poston, Managing Partner, Kalypso and airs on Wednesday, September 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
In today’s challenging market, an effective portfolio management process is essential to help medical device companies select those product ideas with the greatest commercial potential, and thereby maximize the return on their investments even when resources are limited. However, there is a big difference between portfolio management theory and how it is typically practiced in leading corporations. Product Portfolio Management (PPM) best practices and software should facilitate and support real-time portfolio analysis, but are they really being leveraged to their greatest benefit?
This audio conference presentation explores a practical, real-world approach to simple product portfolio management that will enable your company to define priorities and deliver on strategic objectives. The speaker provides valuable insight on six pragmatic PPM practices that add the most value with the least amount of effort.
In today’s challenging market, an effective portfolio management process is essential to help medical device companies select those product ideas with the greatest commercial potential, and thereby maximize the return on their investments even when resources are limited. However, there is a big difference between portfolio management theory and how it is typically practiced in leading corporations. Product Portfolio Management (PPM) best practices and software should facilitate and support real-time portfolio analysis, but are they really being leveraged to their greatest benefit?
This audio conference presentation explores a practical, real-world approach to simple product portfolio management that will enable your company to define priorities and deliver on strategic objectives. The speaker provides valuable insight on six pragmatic PPM practices that add the most value with the least amount of effort.
Monday, August 16, 2010
Renewable Energy: Industry Overview & Current Trends
is being presented by Federico Fische, Renewable Energy Consultant and airs on Wednesday, October 13th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Renewable energy is a mature sector and is constantly being tested for reliability as the alternative to fossil fuels. The government – both at federal and state level, politicians, entrepreneurs, academics and the media are bombarding the market with information, regulations, incentives, new ideas and technologies.
Most of the time, this information is about the promising future of renewable energy. However, this presentation focuses on the present and covers the basics: concepts and terminology, alternative technologies and their uses, and current trends and solutions. All US States have their own mandates on renewable energy and Congress is considering a federal bill too. In this environment, it is important that consumers, companies and other organizations understand what renewable energy is all about, to support their decision-making process.
Renewable energy is a mature sector and is constantly being tested for reliability as the alternative to fossil fuels. The government – both at federal and state level, politicians, entrepreneurs, academics and the media are bombarding the market with information, regulations, incentives, new ideas and technologies.
Most of the time, this information is about the promising future of renewable energy. However, this presentation focuses on the present and covers the basics: concepts and terminology, alternative technologies and their uses, and current trends and solutions. All US States have their own mandates on renewable energy and Congress is considering a federal bill too. In this environment, it is important that consumers, companies and other organizations understand what renewable energy is all about, to support their decision-making process.
Friday, August 13, 2010
Using Local Laboratory Data in Phase II and III Pivotal Studies
is being presented by Jaap H.M. Dijkman, CEO, of Medial NL and airs on Thursday, September 23rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.
Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.
Thursday, August 12, 2010
Optimizing Resource Allocation and Capacity Planning
is being presented by Vladimir Shnaydman, President, of ORBee Consulting and airs on Wednesday, September 15th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Under constant pressure to reduce the cost of drug development, many biopharmaceutical companies and CROs are looking for ways to improve their capacity planning and resource allocation. It is critical for clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for a portfolio of clinical trials. An optimal capacity planning solution includes proper resource utilization, allocation between ongoing and new trials, outsourcing strategy, hiring trend and budget allocation strategy for a variety of employee roles, and resource reallocation due to new or cancelled trials. It means identifying resource bottlenecks and optimal scheduling of new trials.
In this presentation, the speaker discusses a powerful decision-making methodology based on rigorous mathematical models for optimal capacity planning and resource allocation in clinical research, a technique which has been shown to reduce costs by up to 30% in some cases by uncovering better resource allocation solutions.
Under constant pressure to reduce the cost of drug development, many biopharmaceutical companies and CROs are looking for ways to improve their capacity planning and resource allocation. It is critical for clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for a portfolio of clinical trials. An optimal capacity planning solution includes proper resource utilization, allocation between ongoing and new trials, outsourcing strategy, hiring trend and budget allocation strategy for a variety of employee roles, and resource reallocation due to new or cancelled trials. It means identifying resource bottlenecks and optimal scheduling of new trials.
In this presentation, the speaker discusses a powerful decision-making methodology based on rigorous mathematical models for optimal capacity planning and resource allocation in clinical research, a technique which has been shown to reduce costs by up to 30% in some cases by uncovering better resource allocation solutions.
Wednesday, August 11, 2010
Conducting Laboratory Out-of-Specification Investigations
is being presented by Jerry Lanese, President, of The Lanese Group, Inc and airs on Tuesday, September 7th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Inadequate procedures for laboratory out-of-specification (OOS) investigations remains high on the list of FDA observations. Although the FDA's interest in how pharmaceutical firms handle OOS laboratory results began more than 15 years ago, and the Agency has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA investigator review and findings.
An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this audio conference we discuss the investigation that goes on within the laboratory. Although the focus is on the FDA guidance, the discussion includes suggestions for a process that will meet the FDA expectations.
Inadequate procedures for laboratory out-of-specification (OOS) investigations remains high on the list of FDA observations. Although the FDA's interest in how pharmaceutical firms handle OOS laboratory results began more than 15 years ago, and the Agency has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA investigator review and findings.
An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion. There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this audio conference we discuss the investigation that goes on within the laboratory. Although the focus is on the FDA guidance, the discussion includes suggestions for a process that will meet the FDA expectations.
Tuesday, August 10, 2010
Failure Modes & Effects Analysis (FMEA)
is being presented by Angelo Scangas, President, of Quality Support Group, Inc. and airs on Tuesday, August 31st. For more details or to register for this event, please visit our site at www.fxconferences.com
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Monday, August 9, 2010
Preventing Bacterial and Mold Spore Excursions
is being presented by Jim Polarine, Technical Service Specialist, with STERIS Corporation and airs on Thursday, August 26th. For more details or to register, please visit our site at www.fxconferences.com
The pharma and biotech industry has seen an increase in the number and species of bacterial endospores and mold spores found in facilities. This presentation focuses on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms, and limit other sources of spore contamination. The speaker discusses sporicidal products and their efficacy, and presents data which can be used to address bacterial spore issues, also reviewing current sporicide regulation in the US and Europe.
The presentation covers current issues in the industry and provides a better understanding of how to prevent outbreaks. Registrants hear about industry experiences, and troubleshooting methods for bacterial spore contamination issues. The presentation is designed to provide a better understanding of how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical to developing a successful contamination control program.
The pharma and biotech industry has seen an increase in the number and species of bacterial endospores and mold spores found in facilities. This presentation focuses on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms, and limit other sources of spore contamination. The speaker discusses sporicidal products and their efficacy, and presents data which can be used to address bacterial spore issues, also reviewing current sporicide regulation in the US and Europe.
The presentation covers current issues in the industry and provides a better understanding of how to prevent outbreaks. Registrants hear about industry experiences, and troubleshooting methods for bacterial spore contamination issues. The presentation is designed to provide a better understanding of how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical to developing a successful contamination control program.
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