is being presented by Dr Pete Harpum, Harpum Consulting and airs on Thursday, March 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
The focus of work in the drug development industry is inexorably moving away from vertically integrated pharmaceutical and biotechnology companies – the ‘sponsors’ – to contract research organizations (CROs) and other third-party suppliers of services. Approximately 350,000 people have left employment in pharmaceutical and biotechnology companies – but they did not leave the industry. Many of these people moved from the sponsor/client side to the CRO/seller side. Drug development work is now increasingly done by third parties: the challenge facing industry is how to maintain and improve quality of service?
Partnering is a valuable strategy for clients and sellers to work together. In this presentation our speaker draws upon the lessons of other industries in which the majority of work is carried out by third parties in partnership with buyers, and looks at how partnering can facilitate high quality service provision by CROs.
Monday, March 19, 2012
Wednesday, March 14, 2012
Monitoring Essentials for Medical Device Trials
is being presented by Helen Colquhoun, CEO, Pleiad Inc. and airs on Wednesday, March 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.
In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.
Monday, March 12, 2012
The Revised RoHS Directive and What It Means for Device Manufacturers
is being presented by Dr. Joachim Wilke, Director, Regulatory Affairs & Policy, Europe, with Medtronic and airs on Thursday, March 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
Friday, March 9, 2012
Improving Study Feasibility- Why Sites Fail and How to Avoid It
is being presented by Nikki Christison, President, of Clinical Resolutions and airs on Wednesday, March 14th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.
Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.
This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.
Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.
Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.
This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.
Monday, March 5, 2012
Industry Update – China's Evolving Medical Device Regulations
is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, March 13th, 2012. For more details, or to register please visit our site at www.fxconferences.com
China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.
This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.
China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.
This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.
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