is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Tuesday, November 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).
Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.
Tuesday, October 25, 2011
Tuesday, October 18, 2011
Technical Documentation Requirements for Device Approval in the EU
is being presented by Tamas Borsai, Division Manager, MHS - Customer Service and Quality, with TUV SUD America Inc. and airs on Thursday, November 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Having a technical file for each medical product is one of the common and very basic requirements in all of the European medical device directives. Creating and maintaining these documents requires the proper expertise and strategy from those working in regulatory affairs for the device manufacturer.
The updated Medical Devices Directive – which became effective in 2009 - requests that Notified Bodies set up sampling programs of the technical files for all of their clients, and so the chance of a detailed review of a file by an auditor is higher than at any time previous.
This audio conference covers the regulatory framework with references to the European directives and guidance documents, possible strategies for setting up the technical file, and includes an illustrative case study.
Friday, October 14, 2011
EU Guidance on Stand-Alone Software Under the Medical Devices Directive
is being presented by Erik Vollebregt, Partner, with Axon and airs on Tuesday, November 8th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
EU medical devices regulation is very much in flux: the European Commission is working on the text of the recast of the medical devices directive (MDD), and work is underway on a new guidance on stand-alone software under the MDD. In the meantime, medical device companies are producing more software-enabled devices and software that might qualify as medical devices. Clinical institutions and others are developing an increasing number of medical apps and websites with diagnostic and therapeutic functionality. Given these developments, it is vital for companies and institutions to be aware of how these products are regulated, and to determine if and how their software products are regulated.
This audio conference presentation reviews the current EU rules for software related to or incorporated within medical devices, and also sheds light on where these regulations are likely headed in the future. Our speaker also discusses FDA guidance on mobile medical apps, and how it can help guide companies in their efforts in Europe.
EU medical devices regulation is very much in flux: the European Commission is working on the text of the recast of the medical devices directive (MDD), and work is underway on a new guidance on stand-alone software under the MDD. In the meantime, medical device companies are producing more software-enabled devices and software that might qualify as medical devices. Clinical institutions and others are developing an increasing number of medical apps and websites with diagnostic and therapeutic functionality. Given these developments, it is vital for companies and institutions to be aware of how these products are regulated, and to determine if and how their software products are regulated.
This audio conference presentation reviews the current EU rules for software related to or incorporated within medical devices, and also sheds light on where these regulations are likely headed in the future. Our speaker also discusses FDA guidance on mobile medical apps, and how it can help guide companies in their efforts in Europe.
Wednesday, October 12, 2011
Industry Update – European Human Tissues Regulation
is being presented by Richard van der Linden, Senior Consultant, with Signifix and airs on Tuesday, November 8th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.
In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.
This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.
Since the gradual implementation of the Human Tissues and Cells Directive 2004/23/EC (EUTCD) in the European Union, industry and hospitals now know the minimal safety and quality requirements for products made from human tissues and cells. The EUTCD’s transposition defines a framework defining Tissue Establishments (TE) – which can be profit or non-profit organizations – as centers via which the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells is regulated. Within the Tissue Establishment, the Responsible Person (RP) is responsible for safeguarding the safety and quality of the human tissues and cells.
In addition, a number of EU member states have put in place their own country-specific requirements on donor tissues and cells, which sometimes runs contrary to “free movement of tissues and cells” between member states, and puts constraints on acceptability of tissue and cell donors and the routes via which a tissue or cell product can cross borders.
This audio conference addresses the implications of transposition of the EUTCD in the different member states, reviews the definitions of TE and RP, and provides an update for attendees on the extra country-specific requirements added by individual member states.
Friday, October 7, 2011
FDA Imports: How to Deal with Holds, Detentions and Refusals
is being presented by Kyle Sampson, Partner, with Hunton & Williams LLP and airs on Thursday, November 3rd, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA may detain and ultimately refuse the admission of food, drugs, devices and cosmetics offered for import if the products “appear” to violate regulatory requirements. FDA also may subject products, manufacturers, and countries to “detention without physical examination.” These FDA authorities are significant, as 40% of the drugs Americans take are manufactured outside the U.S., and 80% of active pharmaceutical ingredients come from non-U.S. sources. In 2011, more than 24 million shipments of FDA regulated products will be offered for import.
In recent years, lawmakers have pressed FDA to monitor imports more closely, driven by incidents of fatal drug contamination – like the 2008 incident involving the blood thinner Heparin. In response, FDA has launched new enforcement initiatives and increased the number of import holds, detentions and refusals. So how can importers adjust to this new reality? And what should they do if they run afoul of FDA? This audio conference presentation explains FDA’s powers in this area, recommends steps to avoid import problems, and describes how to fight holds, detentions and refusals.
The FDA may detain and ultimately refuse the admission of food, drugs, devices and cosmetics offered for import if the products “appear” to violate regulatory requirements. FDA also may subject products, manufacturers, and countries to “detention without physical examination.” These FDA authorities are significant, as 40% of the drugs Americans take are manufactured outside the U.S., and 80% of active pharmaceutical ingredients come from non-U.S. sources. In 2011, more than 24 million shipments of FDA regulated products will be offered for import.
In recent years, lawmakers have pressed FDA to monitor imports more closely, driven by incidents of fatal drug contamination – like the 2008 incident involving the blood thinner Heparin. In response, FDA has launched new enforcement initiatives and increased the number of import holds, detentions and refusals. So how can importers adjust to this new reality? And what should they do if they run afoul of FDA? This audio conference presentation explains FDA’s powers in this area, recommends steps to avoid import problems, and describes how to fight holds, detentions and refusals.
Tuesday, October 4, 2011
Best Practices for Conducting Ophthalmology Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, November 2nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
There are many challenges facing those who design, set up, and monitor ophthalmology trials. The first is deciding whether to study one eye or both eyes, and to understand the statistical implications of that choice. The next challenge is to understand the many assessments, measurements, and endpoints utilized in ophthalmology trials, and how to standardize their collection over many sites. Finally, monitors need to understand the data they are monitoring, in order to identify adverse trends and improbable values, thereby improving data quality.
In this audio conference, our speaker reviews the common and some not-so-common ophthalmic tests used as outcome measures in clinical trials, giving pointers for monitoring best practices in ophthalmology, and discussing site certification and standardization. The presentation also describes the statistical and study design issues, so that attendees understand how they will impact their decisions about study design and analysis.
There are many challenges facing those who design, set up, and monitor ophthalmology trials. The first is deciding whether to study one eye or both eyes, and to understand the statistical implications of that choice. The next challenge is to understand the many assessments, measurements, and endpoints utilized in ophthalmology trials, and how to standardize their collection over many sites. Finally, monitors need to understand the data they are monitoring, in order to identify adverse trends and improbable values, thereby improving data quality.
In this audio conference, our speaker reviews the common and some not-so-common ophthalmic tests used as outcome measures in clinical trials, giving pointers for monitoring best practices in ophthalmology, and discussing site certification and standardization. The presentation also describes the statistical and study design issues, so that attendees understand how they will impact their decisions about study design and analysis.
Monday, October 3, 2011
Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)
is being presented by Dr. Andrew Marr, Managing Director, of Marr Consultancy Limited and airs on Tuesday, Novemeber 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.
EMA has issued a detailed guidance and technical specification for providing this information – both data and product information (labeling) documents. These requirements pose a major challenge for industry to provide quality data on time. This audio conference presentation reviews the information EMA needs – and why – and discusses business process and technical options available to Marketing Authorization Holders, to support provision of data as required to EMA.
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