is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, August 3rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.
In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.
This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.
Wednesday, June 29, 2011
Tuesday, June 28, 2011
Off-label Promotion – What FDA Looks For & What You Need to Know
is being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Tuesday, July 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Off-label promotion is a perennial focus for FDA enforcement actions, and an area of chronic concern for pharmaceutical and medical device companies. The dividing line between legitimate scientific exchange of information and off-label promotion can, at times, be somewhat blurry. It is vitally important for everyone on your team to know what can and cannot be said in the name of product promotion, and for your company to have in place a strategy to stay compliant.
In this audio conference, our speaker reviews the regulations concerning product promotion in the life sciences, sharing experience and insight on some of the red-flag areas likely to attract unwanted attention from FDA. The presentation looks at the Good Reprint Practices guidance, and what it does and does not say about sharing off-label information. It also discusses the role of medical affairs and the medical science liaison, and reviews factors to consider when determining what is and is not acceptable promotional activity.
Off-label promotion is a perennial focus for FDA enforcement actions, and an area of chronic concern for pharmaceutical and medical device companies. The dividing line between legitimate scientific exchange of information and off-label promotion can, at times, be somewhat blurry. It is vitally important for everyone on your team to know what can and cannot be said in the name of product promotion, and for your company to have in place a strategy to stay compliant.
In this audio conference, our speaker reviews the regulations concerning product promotion in the life sciences, sharing experience and insight on some of the red-flag areas likely to attract unwanted attention from FDA. The presentation looks at the Good Reprint Practices guidance, and what it does and does not say about sharing off-label information. It also discusses the role of medical affairs and the medical science liaison, and reviews factors to consider when determining what is and is not acceptable promotional activity.
Friday, June 24, 2011
Using FDA’s Regulatory Harmonization to Better Manage a Global Supply Chain
is being presented by John Avellanet, President, of Cerulean Associates LLC and airs on Wednesday, July 27th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The FDA’s Office of Compliance is reorganizing this year to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Mr. Avellanet also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
The FDA’s Office of Compliance is reorganizing this year to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Mr. Avellanet also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
Tuesday, June 21, 2011
Negotiating Clinical Study Agreements With Academic Medical Institutions
is being presented by Karen A. Mullin, JD, LLM and airs on Wednesday, July 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.
The process of negotiating a clinical study agreement between a bio/pharmaceutical company and an academic medical institution can be difficult, in part due to the sometimes divergent goals of the two parties. This audio conference presentation reviews the expectations of both the bio/pharmaceutical company and the academic medical institution when negotiating clinical study agreements. Our speaker addresses in depth the key issues of confidentiality, publication, intellectual property rights and indemnification. The presentation also includes discussion of appropriate language to enable the parties to fulfill their different objectives and legal obligations. Finally, our speaker shares tips and insight on ways to speed up the negotiating process.
Wednesday, June 15, 2011
GFSI Certification – Pitfalls and Best Practices
is being presented by Peter Stein, Corporate Director of Quality Assurance and Food Safety, with Piller's Corporation and airs on Thursday, July 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The Global Food Safety Initiative (GFSI) standard was developed with the stated goal of encouraging continuous improvement in food safety management systems. However, for those companies seeking certification to the standard, the exact methodology isn't always clear. There are numerous aspects of the process and the audit that are not evident in the manual, and the specific requirements that must be met to achieve a passing grade can be somewhat dependent on the auditor.
This presentation provides an overview of the GFSI standard and, specifically, the SQF certification process. Our speaker, the corporate director of food safety and quality assurance with Piller's Corporation, discusses why Piller's chose SQF, and shares audit experiences at four further-processed RTE meat plants over the past two years. The presentation provides insight on what you need to know and where to start, as well as tips to help you pass the first time. The speaker also covers the interaction and cooperation needed from other departments, and the emphasis on in-plant auditing and questions asked to on-line workers in the plant. Finally, the presentation also reviews the scoring process and the audit summary itself.
The Global Food Safety Initiative (GFSI) standard was developed with the stated goal of encouraging continuous improvement in food safety management systems. However, for those companies seeking certification to the standard, the exact methodology isn't always clear. There are numerous aspects of the process and the audit that are not evident in the manual, and the specific requirements that must be met to achieve a passing grade can be somewhat dependent on the auditor.
This presentation provides an overview of the GFSI standard and, specifically, the SQF certification process. Our speaker, the corporate director of food safety and quality assurance with Piller's Corporation, discusses why Piller's chose SQF, and shares audit experiences at four further-processed RTE meat plants over the past two years. The presentation provides insight on what you need to know and where to start, as well as tips to help you pass the first time. The speaker also covers the interaction and cooperation needed from other departments, and the emphasis on in-plant auditing and questions asked to on-line workers in the plant. Finally, the presentation also reviews the scoring process and the audit summary itself.
Tuesday, June 14, 2011
3 Steps to Successful Translation Management
is being presented by Andres Heuberger, President, of ForeignExchange Translations, Inc. and airs on Thursday, July 7th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Translators have been around since the time of the Babylonians, yet the translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but more and more companies are looking for a true partner that can help them effectively manage the translation process.
This audio conference gives you the skills to evaluate different vendors, service delivery methods and quality. It also enables you to put in place a process to document, measure, audit and improve your overall translation activities.
Wednesday, June 8, 2011
Managing Risk Under the Physician Payment Sunshine Law and Anti-kickback Statute
is being presented by Sheva Sanders, Partner with, Leonard, Street and Deinard and airs on Wednesday, June 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com
As device-related therapies have become more complex, and technological capabilities have become more sophisticated, medical device companies have expanded their activities in support of those therapies. For example, many companies provide substantial and valuable support related to stocking their products, training and education on the use of their products, reimbursement-related support, and post-implant monitoring.
At the same time, laws such as the Physician Sunshine Payment Act and the Anti-kickback Statute – focusing on the perceived conflict of interest created through the transfer of value to provider-customers – have made it critical to be able to identify reportable or prohibited transfers of value.
This audio conference presentation explores the question of whether and when the product-related support activities are reportable under the Physician Sunshine Payment Act and similar state statutes, and whether and when such activities might constitute remuneration under the federal Anti-kickback Statute and similar state statutes.
As device-related therapies have become more complex, and technological capabilities have become more sophisticated, medical device companies have expanded their activities in support of those therapies. For example, many companies provide substantial and valuable support related to stocking their products, training and education on the use of their products, reimbursement-related support, and post-implant monitoring.
At the same time, laws such as the Physician Sunshine Payment Act and the Anti-kickback Statute – focusing on the perceived conflict of interest created through the transfer of value to provider-customers – have made it critical to be able to identify reportable or prohibited transfers of value.
This audio conference presentation explores the question of whether and when the product-related support activities are reportable under the Physician Sunshine Payment Act and similar state statutes, and whether and when such activities might constitute remuneration under the federal Anti-kickback Statute and similar state statutes.
Tuesday, June 7, 2011
Medical Market Research Best Practices: Not Just for the Marketing Department
is being presented by Maria Shepherd and airs on Thursday, June 30th, 2011. For more details on this event, or to register please visit our site at www.fxconferences.com
The medical device industry is complex and unique. Medical market research is utilized by a number of other departments in medical device companies, beyond the marketing department. FDA expects regulatory departments to provide market sizing data in submissions. The quality department needs usability research (a sister science to market research in form, but not function) for Human Factors Engineering usability testing mandates by FDA. R&D departments use Voice of the Customer, a tool that relies heavily on solid market research principles to obtain and analyze customer feedback on new product design.
This audio conference reviews basic principles and best practices for finding the market data and clinician (or patient/stakeholder) input that you need to meet the data collection objectives your function requires. The speaker will discuss these techniques and present several examples of market sizing data for regulatory submissions and human factors usability testing tools and best practices. Market research techniques for Voice of the Customer will also be covered in this audio conference, and will review identifying, profiling, screening and recruiting respondents for VOC research. An overview of best practices in interviewing and discussion guide development for the VOC qualitative in-depth component will be reviewed as well as developing, administering and analyzing online surveys for the quantitative component.
The medical device industry is complex and unique. Medical market research is utilized by a number of other departments in medical device companies, beyond the marketing department. FDA expects regulatory departments to provide market sizing data in submissions. The quality department needs usability research (a sister science to market research in form, but not function) for Human Factors Engineering usability testing mandates by FDA. R&D departments use Voice of the Customer, a tool that relies heavily on solid market research principles to obtain and analyze customer feedback on new product design.
This audio conference reviews basic principles and best practices for finding the market data and clinician (or patient/stakeholder) input that you need to meet the data collection objectives your function requires. The speaker will discuss these techniques and present several examples of market sizing data for regulatory submissions and human factors usability testing tools and best practices. Market research techniques for Voice of the Customer will also be covered in this audio conference, and will review identifying, profiling, screening and recruiting respondents for VOC research. An overview of best practices in interviewing and discussion guide development for the VOC qualitative in-depth component will be reviewed as well as developing, administering and analyzing online surveys for the quantitative component.
Thursday, June 2, 2011
Management Responsibilities Under FDA's Quality System Regulation
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, July 28th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA’s Quality System Regulation (QSR), for medical devices marketed in the US, includes requirements for management responsibility. There are five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. This presentation explains the various components and offers recommendations for implementation.
It also examines the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding, and this presentation looks at these terms and explains what they mean.
Our speaker draws on many sources to provide attendees with understanding, including the regulation preamble – where FDA published its reasoning, intent and expectations – and also FDA’s Quality System Inspection Technique, which guides inspectors.
The presentation also examines some FDA warning letters to help participants understand the issues that FDA uncovers and considers important.
The FDA’s Quality System Regulation (QSR), for medical devices marketed in the US, includes requirements for management responsibility. There are five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. This presentation explains the various components and offers recommendations for implementation.
It also examines the structure of regulation in 21 CFR §820.20 and its constituent parts. This section has many defined terms that bear on the understanding, and this presentation looks at these terms and explains what they mean.
Our speaker draws on many sources to provide attendees with understanding, including the regulation preamble – where FDA published its reasoning, intent and expectations – and also FDA’s Quality System Inspection Technique, which guides inspectors.
The presentation also examines some FDA warning letters to help participants understand the issues that FDA uncovers and considers important.
Wednesday, June 1, 2011
Complying with FCPA and Related Anti-Corruption Measures
is being presented by David F. Axelrod, Managing Member, with Axelrod Laliberte LLP and airs on Wednesday, June 22nd, 2011. For more details, or to register please visit our site at www.fxconferences.com
For the first 20 years of its existence, the Foreign Corrupt Practices Act (FCPA) was rarely used, and EU countries had nothing comparable. More recently, however, the FCPA has been aggressively enforced against individuals, as well as U.S. and foreign companies. Fines have been imposed at unprecedented levels and individuals (including a former U.S. Congressman) jailed. EU governments have also gotten serious about fighting corruption, starting with the 1998 OECD convention against bribery and culminating, so far, with the UK anti-bribery statute.
This audio conference presentation looks at the history, scope and elements of the FCPA, anti-corruption compliance programs, red flags, investigations, and U.S. government expectations for pre-transaction due diligence. It also covers defenses and policy considerations concerning a key exception to liability, facilitating payments. Our speaker also discusses the UK anti-bribery statute and its key differences from the FCPA. Finally, the presentation looks at the relevance of the statute to smaller companies that may have only a limited overseas presence.
For the first 20 years of its existence, the Foreign Corrupt Practices Act (FCPA) was rarely used, and EU countries had nothing comparable. More recently, however, the FCPA has been aggressively enforced against individuals, as well as U.S. and foreign companies. Fines have been imposed at unprecedented levels and individuals (including a former U.S. Congressman) jailed. EU governments have also gotten serious about fighting corruption, starting with the 1998 OECD convention against bribery and culminating, so far, with the UK anti-bribery statute.
This audio conference presentation looks at the history, scope and elements of the FCPA, anti-corruption compliance programs, red flags, investigations, and U.S. government expectations for pre-transaction due diligence. It also covers defenses and policy considerations concerning a key exception to liability, facilitating payments. Our speaker also discusses the UK anti-bribery statute and its key differences from the FCPA. Finally, the presentation looks at the relevance of the statute to smaller companies that may have only a limited overseas presence.
Subscribe to:
Posts (Atom)