is being presented by Dr. Max Horneck, Head of eClinical Services, with Wega Informatik AG and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com
There is no question that gathering real-life data on approved drug products is of vital importance. Data collected for marketed drugs is needed to generate thorough knowledge of the safety, efficacy and effectiveness. The challenge for clinical operations arises from significant cost pressure in post-authorization studies, while attempting to maintain an adequate level of quality and achieving study targets. Experience has shown that simply mapping procedures from early to late phase does not give the desired results. Budgets tend to be overstressed while targets and quality remain in danger.
In this audio conference, our speaker draws upon almost two decades of clinical experience and provides insight on how to to effectively maintain control of the study conduct and quality of data with reduced efforts by the use of risk mitigation, regional service providers and business intelligence. This presentation enables the attendees to safely plan and conduct late phase studies at significantly reduced costs while maintaining compliance with current regulations at the desired level of quality.
Thursday, December 15, 2011
Wednesday, December 7, 2011
eLabeling Medical Devices for the EU Market
is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Tuesday, January 10th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Tuesday, December 6, 2011
Best Practices for Successfully Implementing a Global Content Management System
is being presented by Jason Arnsparger, Solutions Development Consultant, with ForeignExchange Translations, Inc. and airs on Thursday, January 12th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content.
In this presentation, our speaker draws upon first-hand experience, first with a medical device company and more recently with a localization provider, and discusses tips, challenges, best practices and lessons learned with CMS implementations. Attendees receive valuable insight and hear first-hand how to reap the CMS benefits while minimizing implementation headaches.
Thinking about implementing a content management system? As the demand for technical, training, marketing documentation and product labeling increases, so too does the need to deliver this content more quickly and in more languages. To meet these requirements, many regulated companies are migrating towards structured authoring and content management systems that enable the re-use and re-purposing of existing content.
In this presentation, our speaker draws upon first-hand experience, first with a medical device company and more recently with a localization provider, and discusses tips, challenges, best practices and lessons learned with CMS implementations. Attendees receive valuable insight and hear first-hand how to reap the CMS benefits while minimizing implementation headaches.
Monday, December 5, 2011
Opportunities in the European Regulatory Framework for Orphan Medicinal Products
is being presented by Dr. Maureen Graham, Managing Director, of Diamond BioPharm Limited and airs on Wednesday, January 11th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.
This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.
The orphan drug regulation in Europe came into force over 10 years ago, with the aim of stimulating research and development of medicinal products for rare diseases. Obtaining and maintaining orphan status opens up a number of opportunities to companies developing such products, but it is crucial to have a thorough understanding of the orphan rules in Europe in order to fully benefit from the incentives offered.
This audio conference presentation provides an overview of the legislative framework, and highlights the incentives available. Our speaker focuses on the most important aspects that need to be considered when compiling an application for orphan designation, and how this may impact the development program. Finally, the presentation summarizes both the potential pros and cons will be summarized.
Thursday, December 1, 2011
Developing Effective Quality Agreements: Legal and Regulatory Issues
ia being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Wednesday, December 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.
In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.
Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.
In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.
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