is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Wednesday, June 1st, 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.
Friday, April 29, 2011
Thursday, April 28, 2011
Device Master Records & Device History Records: Are You Compliant?
is being presented by Dan O'Leary, President, with Ombu Enterprises and airs on Thursday, May 26th, 2011. For more details, or to register for this event please visit our site at www.fxconferences.com
The Device Master Record (DMR) and the Device History Record (DHR) serve to document your manufacturing process and the results, and also to assist in solving problems. Equally important, your DMR and DRH must align, and during an FDA inspection the investigator will check to make sure they do! Now is the time to understand, before you have to explain in a 483 response.
The DMR and DHR are part of four related documents that are important to your QMS. During design, you will create a Design History File (DHF) documenting how you developed the design and moved it to production. One of the major design outputs is the Device Master Record (DMR). However, you can put some of the information into the Quality System Record (QSR), which you must also create.
This audio conference presentation discusses the difference between the DMR and the QSR, and how to organize your information. While focusing on the DMR and DHR, the speaker also provides a roadmap for understanding the interlocking relationship among all four critical records. With this knowledge, you can ensure your QMS is efficient, effective, and compliant.
The Device Master Record (DMR) and the Device History Record (DHR) serve to document your manufacturing process and the results, and also to assist in solving problems. Equally important, your DMR and DRH must align, and during an FDA inspection the investigator will check to make sure they do! Now is the time to understand, before you have to explain in a 483 response.
The DMR and DHR are part of four related documents that are important to your QMS. During design, you will create a Design History File (DHF) documenting how you developed the design and moved it to production. One of the major design outputs is the Device Master Record (DMR). However, you can put some of the information into the Quality System Record (QSR), which you must also create.
This audio conference presentation discusses the difference between the DMR and the QSR, and how to organize your information. While focusing on the DMR and DHR, the speaker also provides a roadmap for understanding the interlocking relationship among all four critical records. With this knowledge, you can ensure your QMS is efficient, effective, and compliant.
Tuesday, April 26, 2011
Social Media Policies and Practices for Food and Beverage Marketers
is being presented by Allison Fitzpatrick, Davis & Gilbert LLP & Laura J. Protzmann, The Dannon Company, Inc and airs on Tuesday, May 17th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Food and beverage marketers are under significant regulatory scrutiny these days, and it is imperative that they put in place policies and practices that are compliant with applicable law. This audio conference presentation looks at the laws which apply to food and beverage marketers, including the use of social media in promoting products. Attendees learn about the Federal Trade Commission's endorsement guides, and the impact they have on the food and beverage industry. Our speakers also review recent enforcement actions aimed at food product marketers, and provide tips on how their policies and practices can comply with the law. The presentation provides attendees with practical, take-home advice on how to go about promoting products without running afoul of regulators.
Food and beverage marketers are under significant regulatory scrutiny these days, and it is imperative that they put in place policies and practices that are compliant with applicable law. This audio conference presentation looks at the laws which apply to food and beverage marketers, including the use of social media in promoting products. Attendees learn about the Federal Trade Commission's endorsement guides, and the impact they have on the food and beverage industry. Our speakers also review recent enforcement actions aimed at food product marketers, and provide tips on how their policies and practices can comply with the law. The presentation provides attendees with practical, take-home advice on how to go about promoting products without running afoul of regulators.
Monday, April 25, 2011
The UK Bribery Act and What US Companies Need to Know About It
is being presented by Adam Greaves & William Boddy, with McGuireWoods and airs on Tuesday, May 17th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The UK Bribery Act, which comes into force July 1, 2011, is a comprehensive piece of legislation modeled after, but going beyond, the U.S. Foreign Corrupt Practices Act. The Bribery Act is broad in scope and will have implications not just for UK businesses, but for any foreign organizations having business interests in that country. The British government has recently released Guidance on the Act, intended to help organizations understand how it will work, and how to deal with the risks of bribery. But while the Guidance provides insights into how the Act might be interpreted, it does not give assurances. And while it suggests procedures that might be adequate, it does not set down rules.
When the Act comes into force, its provisions will impact not only companies and partnerships formed or incorporated in the UK, but all foreign organizations that carry out business in the UK. This audio conference presentation provides an overview of the provisions of the Act, and how they will impact US companies.
The UK Bribery Act, which comes into force July 1, 2011, is a comprehensive piece of legislation modeled after, but going beyond, the U.S. Foreign Corrupt Practices Act. The Bribery Act is broad in scope and will have implications not just for UK businesses, but for any foreign organizations having business interests in that country. The British government has recently released Guidance on the Act, intended to help organizations understand how it will work, and how to deal with the risks of bribery. But while the Guidance provides insights into how the Act might be interpreted, it does not give assurances. And while it suggests procedures that might be adequate, it does not set down rules.
When the Act comes into force, its provisions will impact not only companies and partnerships formed or incorporated in the UK, but all foreign organizations that carry out business in the UK. This audio conference presentation provides an overview of the provisions of the Act, and how they will impact US companies.
Thursday, April 21, 2011
Food Advertising & Labeling Substantiation: Responding to Heightened Enforcement Risks
is being presented by Bruce A. Silverglade, JD, OFW Law PC and airs on Wednesday, May 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Food and beverage companies making health benefit claims in their product advertising and labeling have been coming under increased scrutiny, and facing heightened regulatory and enforcement risks.
This audio conference presentation explores the implications of new FTC and FDA compliance standards, and discusses how to minimize exposure to these increased enforcement activities. Attendees also learn how federal actions can lead to class action lawsuits against food and beverage companies at the state level, and the steps that can be taken in advance to mitigate the risk.
Food and beverage companies making health benefit claims in their product advertising and labeling have been coming under increased scrutiny, and facing heightened regulatory and enforcement risks.
This audio conference presentation explores the implications of new FTC and FDA compliance standards, and discusses how to minimize exposure to these increased enforcement activities. Attendees also learn how federal actions can lead to class action lawsuits against food and beverage companies at the state level, and the steps that can be taken in advance to mitigate the risk.
Wednesday, April 20, 2011
40 CFR Part 98: Complying with the Mandatory GHG Reporting Rule
is being presented by Marc Karell, Climate Change & Environmental Services, LLC and airs on Wednesday, May 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The Federal Mandatory GHG Reporting Rule (40 CFR Part 98), now in effect, is the USEPA’s most complex rule yet. It is the agency’s attempt to collect baseline greenhouse gas (GHG) emissions data from a large variety of facilities likely to be subject to future GHG emission reduction rules. Because this represents a baseline to compare future reductions, the USEPA expects accurate emissions data to be calculated using consistent, complex methods.
Gone are the days when one can use simple methods, as long as emission estimations are conservative. Part 98 requires accuracy. Thus, Part 98 has been written rigidly with detailed requirements for field data collection and management and emission calculation methods.
Facilities preparing for Part 98 are finding that they are spending more resources than expected. In addition, all submitted data must be certified by a company Designated Representative, who is liable for its accuracy. This audio conference will provide background and tips to organize a system to meet the comprehensive Part 98 reporting requirements.
The Federal Mandatory GHG Reporting Rule (40 CFR Part 98), now in effect, is the USEPA’s most complex rule yet. It is the agency’s attempt to collect baseline greenhouse gas (GHG) emissions data from a large variety of facilities likely to be subject to future GHG emission reduction rules. Because this represents a baseline to compare future reductions, the USEPA expects accurate emissions data to be calculated using consistent, complex methods.
Gone are the days when one can use simple methods, as long as emission estimations are conservative. Part 98 requires accuracy. Thus, Part 98 has been written rigidly with detailed requirements for field data collection and management and emission calculation methods.
Facilities preparing for Part 98 are finding that they are spending more resources than expected. In addition, all submitted data must be certified by a company Designated Representative, who is liable for its accuracy. This audio conference will provide background and tips to organize a system to meet the comprehensive Part 98 reporting requirements.
Thursday, April 14, 2011
Quality Systems and Design Control for IVD Products
is being presented by David Kern, Senior Director, Myraqa, RAC MBA and airs on Tuesday, May 31st, 2011. For more details, or to register please visit our site at www.fxconferences.com
The concept of quality systems and design control has been around for over 15 years. Implementing a good quality system correctly is not only required for regulatory compliance, but it makes good business sense as well. However, for many companies, and especially small companies, implementing a system that doesn’t create stifling bureaucracy can be a real challenge. How and when a company implements a quality system can mean the difference between long-term success and a slow, painful path to market..
This audio conference presentation looks at the issue of implementing a quality system and design control for in vitro diagnostics, helping attendees to better understand the steps and components in the process, as well as the benefits of getting it right.
The concept of quality systems and design control has been around for over 15 years. Implementing a good quality system correctly is not only required for regulatory compliance, but it makes good business sense as well. However, for many companies, and especially small companies, implementing a system that doesn’t create stifling bureaucracy can be a real challenge. How and when a company implements a quality system can mean the difference between long-term success and a slow, painful path to market..
This audio conference presentation looks at the issue of implementing a quality system and design control for in vitro diagnostics, helping attendees to better understand the steps and components in the process, as well as the benefits of getting it right.
Wednesday, April 13, 2011
The New Rules for Safety and Performance of Medical Devices in the EU
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Thursday, May 19th, 2011. For more details, or to register please visit our site at www.fxconferences.com
In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.
In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.
Tuesday, April 12, 2011
FERC Enforcement and Interaction with the CFTC
is being presented by Susan J. Court, Partner, with Hogan Lovells LLP and airs on Thursday, May 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The Federal Energy Regulatory Commission (FERC) has significant enforcement authority over companies that engage in the physical movement and wholesale sales of natural gas and electric energy in interstate commerce. This agency, small and not particularly well known, has the power to impose penalties of up to $1 million a day on companies and individuals violating its rules and regulations. It also has explicit authority to police against manipulation of energy markets.
The Commodity Futures Trading Commission (CFTC) recently received vast new authority to oversee the market in derivatives, including energy derivatives, and explicit anti-manipulation authority. FERC and CFTC have been directed to enter into a memorandum of understanding delineating their respective authorities to ensure there are no conflicts between the two.
In this audio conference, our speaker, a former Director of Enforcement with the FERC, discusses the roles and functions of the FERC and the CFTC, and how the two bodies will be interacting moving forward.
The Federal Energy Regulatory Commission (FERC) has significant enforcement authority over companies that engage in the physical movement and wholesale sales of natural gas and electric energy in interstate commerce. This agency, small and not particularly well known, has the power to impose penalties of up to $1 million a day on companies and individuals violating its rules and regulations. It also has explicit authority to police against manipulation of energy markets.
The Commodity Futures Trading Commission (CFTC) recently received vast new authority to oversee the market in derivatives, including energy derivatives, and explicit anti-manipulation authority. FERC and CFTC have been directed to enter into a memorandum of understanding delineating their respective authorities to ensure there are no conflicts between the two.
In this audio conference, our speaker, a former Director of Enforcement with the FERC, discusses the roles and functions of the FERC and the CFTC, and how the two bodies will be interacting moving forward.
Monday, April 11, 2011
Update on Asia Pacific Device Regulation & Harmonization
is being presented by Jeremy Yung, Regulatory Affairs Associate, with ArthroCare Asia Pacific and airs on Wednesday, May 11th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The regulatory environment for medical devices in Asia Pacific has changed significantly in the last five years. Countries that had little or no regulation have now implemented full pe-market reviews, quality systems control and post-market enforcement.
This audio conference presentation provides a country-by-country overview of the changes that have taken place in recent years, and what device companies can expect moving forward. Our speaker discusses the primary Asian markets, and the steps being taken by countries in this region to harmonize and increase the efficiency of device registration. The presentation reviews these developments in detail, and weighs in on how this new landscape will affect life sciences companies in the future.
The regulatory environment for medical devices in Asia Pacific has changed significantly in the last five years. Countries that had little or no regulation have now implemented full pe-market reviews, quality systems control and post-market enforcement.
This audio conference presentation provides a country-by-country overview of the changes that have taken place in recent years, and what device companies can expect moving forward. Our speaker discusses the primary Asian markets, and the steps being taken by countries in this region to harmonize and increase the efficiency of device registration. The presentation reviews these developments in detail, and weighs in on how this new landscape will affect life sciences companies in the future.
Wednesday, April 6, 2011
Best Practices for Building IP and Conducting Due Diligence Investigations
is being presented by Kevin McCabe & Dr. Eldora Ellison, Directors, Biotechnology/Chemical and Litigation Groups, with Sterne, Kessler, Goldstein & Fox P.L.L.C. and airs on Wednesday, May 4th, 2011. For more details or to register, please visit our site at www.fxconferences.com
There has already been a flurry of M&A activity in the life sciences and health technologies fields 2011. This audio conference provides attendees with best practices guidance on how to prepare their intellectual property (IP) for a successful partnering transaction.
Drawing upon a series of case studies involving recent transactions, the presenters discuss what worked well and why, and also the mistakes that could have been avoided. This conference should be of keen interest to companies currently involved in or contemplating entering into a partnering deal, as well the investment community.
There has already been a flurry of M&A activity in the life sciences and health technologies fields 2011. This audio conference provides attendees with best practices guidance on how to prepare their intellectual property (IP) for a successful partnering transaction.
Drawing upon a series of case studies involving recent transactions, the presenters discuss what worked well and why, and also the mistakes that could have been avoided. This conference should be of keen interest to companies currently involved in or contemplating entering into a partnering deal, as well the investment community.
Friday, April 1, 2011
MEDDEV 2.7/3: Best Practices for Clinical Evaluation Reports
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, May 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, clinical trials, or a combination of the two.
This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.
Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, clinical trials, or a combination of the two.
This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.
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