is being presented by Marcus Yoder, Senior Manager, with Kalypso and airs on Tuesday, May 25th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Many medical device companies today have multiple design and development sites performing globally but operating in separate quality management systems (QMS) for product-related processes such as design, manufacturing, distribution, and service. To improve efficiency, consistency, and ease of information transfer, companies should move to harmonizing these systems in one global QMS.
This audio conference discusses ways in which for medical device companies can establish and manage an effective global QMS. Drawing on the results of a research benchmark study involving leading medical device manufacturers, this session looks at how companies are optimizing QMS processes to deliver business benefits and measure quality performance globally.
Friday, April 30, 2010
Thursday, April 29, 2010
Best Practices for Managing In-Country Translation Reviews
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Thursday, May 27th, 2010. For more details or to register, please visit our site at www.fxconferences.com
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
Monday, April 26, 2010
Process Validation for Medical Devices
is being presented by Dan O'Leary, President, Ombu Enterprises and airs on Wednesday, May 19th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.
This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.
An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.
Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.
This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.
An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.
Tuesday, April 20, 2010
Optimizing Regulated Quality Systems with Design Thinking
is being presented by Michael Plishka, Principal, with ZenStorming Solutions, LLC and airs on Wednesday, June 2nd, 2010. For more detail or to register, please visit our site at www.fxconferences.com
Roger Martin, Dean of the Rotman School of Management, said, 'When it comes to innovation, business has much to learn from the world of design...business people need to be designers - to think and work like designers and embed design-shop characteristics in their organizations.'
You're in business to bring some product or service to market. Even with a common vision, various departments and their people have different needs. Add the constraints of regulatory requirements to the mix and sometimes it's a wonder anything gets done in an effective and timely manner. Design tinking is a process for understanding needs and embracing constraints, with the goal of synthesizing solutions that bring value. It goes beyond simple objective analysis of a system, to holistic understanding and empathy, arriving at better solutions through collaboration and experimentation. This audio conference will discuss the basics of design thinking and how it can be used to streamline your quality systems bring value to your business.
Roger Martin, Dean of the Rotman School of Management, said, 'When it comes to innovation, business has much to learn from the world of design...business people need to be designers - to think and work like designers and embed design-shop characteristics in their organizations.'
You're in business to bring some product or service to market. Even with a common vision, various departments and their people have different needs. Add the constraints of regulatory requirements to the mix and sometimes it's a wonder anything gets done in an effective and timely manner. Design tinking is a process for understanding needs and embracing constraints, with the goal of synthesizing solutions that bring value. It goes beyond simple objective analysis of a system, to holistic understanding and empathy, arriving at better solutions through collaboration and experimentation. This audio conference will discuss the basics of design thinking and how it can be used to streamline your quality systems bring value to your business.
Thursday, April 15, 2010
Recent Perspectives on Trial Design - Minimizing Patients for Oncology Trials
is being presented by Dr. John Constant, Vice President Scientific Affairs, with PRA International and airs on Wednesday, May 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.
Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.
Wednesday, April 14, 2010
Nanotechnology – Current Regulation and Future Prospects
is being presented by Dr. Tony Lockett, Medical Director, with Information Change Organisation Ltd and airs on Thursday, May 20, 2010. For more details or to register, please visit our site at www.fxconferences.com
Nanotechnology is an emotional subject for a public concerned about the perceived threat from so-called frankenfoods. The initial response from government has been to do nothing specific, and until recently drugs based on nanomaterials were treated as new chemical entities (NCE). This has led to a considerable delay in the development of nanomaterials – particularly those for medical uses, where full toxicological assessment was often required prior to using these materials in humans.
There are signs that this is changing. The realization that many nanoparticles are in fact natural, and that materials can self assemble in biological systems, has forced a change in the way we think about nanotechnology. However, there is widespread concern over development of national policies to control this technology, and many fear local regulation will lead to commercial interests being put before safety and efficacy. They believe transnational regulation is required – similar to that exercised by the International Conference on Harmonization with regard to pharmaceutical development – to counterbalance commercial interests.
This audio conference presentation will provide an overview of current regulations governing nanotechnology, and discuss future regulatory strategies.
Nanotechnology is an emotional subject for a public concerned about the perceived threat from so-called frankenfoods. The initial response from government has been to do nothing specific, and until recently drugs based on nanomaterials were treated as new chemical entities (NCE). This has led to a considerable delay in the development of nanomaterials – particularly those for medical uses, where full toxicological assessment was often required prior to using these materials in humans.
There are signs that this is changing. The realization that many nanoparticles are in fact natural, and that materials can self assemble in biological systems, has forced a change in the way we think about nanotechnology. However, there is widespread concern over development of national policies to control this technology, and many fear local regulation will lead to commercial interests being put before safety and efficacy. They believe transnational regulation is required – similar to that exercised by the International Conference on Harmonization with regard to pharmaceutical development – to counterbalance commercial interests.
This audio conference presentation will provide an overview of current regulations governing nanotechnology, and discuss future regulatory strategies.
Tuesday, April 13, 2010
Intro to Writing Clinical Study Reports
is being presented by Michael Attella, Senior Regulatory Medical & Scientific Writer, Medical Composition Resources, LLC and airs on Tuesday, May 18th, 2010. For more details or to register, please visit our site at www.fxconferences.com
In an NDA, CTD or BLA, the Clinical Study Report (CSR) can be viewed as a building block for other more integrative and larger-scope regulatory-formatted documents (RFD) like the Integrated Summaries of Safety and Efficacy and even Investigator Brochures. It makes sense then, to train your quantitative writing skills (non-Protocol-oriented, and Results-based) on this most important process.
However, the majority of Regulatory Medical Writers (RMWs) will agree that this skill transcends the ability to write structurally correct grammatical sentences. Unfortunately, the available “how-to” sources for writing RFDs such as CSRs merely reiterate what the FDA sets out in very general descriptive paragraphs in such Guidances as the key E3 [1996] Structure and Content of Clinical Study Reports. There is a method to employ, which, until recently, has only come with experience. This audio conference will detail three of the several facets entailed when writing (and then routing for review) a Phase I, First-in-Humans safety report.
In an NDA, CTD or BLA, the Clinical Study Report (CSR) can be viewed as a building block for other more integrative and larger-scope regulatory-formatted documents (RFD) like the Integrated Summaries of Safety and Efficacy and even Investigator Brochures. It makes sense then, to train your quantitative writing skills (non-Protocol-oriented, and Results-based) on this most important process.
However, the majority of Regulatory Medical Writers (RMWs) will agree that this skill transcends the ability to write structurally correct grammatical sentences. Unfortunately, the available “how-to” sources for writing RFDs such as CSRs merely reiterate what the FDA sets out in very general descriptive paragraphs in such Guidances as the key E3 [1996] Structure and Content of Clinical Study Reports. There is a method to employ, which, until recently, has only come with experience. This audio conference will detail three of the several facets entailed when writing (and then routing for review) a Phase I, First-in-Humans safety report.
Friday, April 9, 2010
Navigating the EU Regulatory Pathway for Advanced Therapy Medicinal Products
is being presented by Damien Bové, Consultant, Medical Tech Development & Regulations and airs on Thursday, May 6th, 2010. For more details or to register, please visit our site at www.fxconferences.com
For many years the European regulatory situation for advanced technologies such as stem cells and gene therapy was unclear and confusing. This presented a considerable challenge to those developing these technologies and those raising finance, as Europe represented a large portion of the global market. To tackle this, European regulators instituted the Advanced Therapies Medicinal Products (ATMP) regulatory pathway to bring clarity to the situation and make Europe an attractive destination for these technologies.
It has been one year since these new regulations came into force, and they appear to be working as intended. They provide clarity, risk management and an open environment for development and fundraising. In this presentation, our speaker explains the frameworks and how developers can use them to fast forward the development process.
For many years the European regulatory situation for advanced technologies such as stem cells and gene therapy was unclear and confusing. This presented a considerable challenge to those developing these technologies and those raising finance, as Europe represented a large portion of the global market. To tackle this, European regulators instituted the Advanced Therapies Medicinal Products (ATMP) regulatory pathway to bring clarity to the situation and make Europe an attractive destination for these technologies.
It has been one year since these new regulations came into force, and they appear to be working as intended. They provide clarity, risk management and an open environment for development and fundraising. In this presentation, our speaker explains the frameworks and how developers can use them to fast forward the development process.
Tuesday, April 6, 2010
Strategies for the New Global MedTech Investment Landscape
is being presented by Guy Sohie, Managing Member, Valeo LLC and airs on Wednesday, May 12, 2010. For more details or to register, please visit our site at www.fxconferences.com
The investor landscape has changed, and medical device companies are scrambling to come up with new strategies to deal with the paradigm shift when commercializing new products. The ripple effect of the financial crisis has hit both venture capital and private equity funds, while regulatory changes continue to make new product development and introduction both longer and more expensive. This, in turn, is impacting innovation throughout the medical device industry.
In this audio conference, our speaker examines this new reality for medical device manufacturers, highlights ways in which leading companies have responded to the challenge, and provides tips and strategies on sourcing funding and attracting investors.
The investor landscape has changed, and medical device companies are scrambling to come up with new strategies to deal with the paradigm shift when commercializing new products. The ripple effect of the financial crisis has hit both venture capital and private equity funds, while regulatory changes continue to make new product development and introduction both longer and more expensive. This, in turn, is impacting innovation throughout the medical device industry.
In this audio conference, our speaker examines this new reality for medical device manufacturers, highlights ways in which leading companies have responded to the challenge, and provides tips and strategies on sourcing funding and attracting investors.
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