is being presented by Leigh Bailey, Founder & CEO, of The Bailey Group and airs on Thursday, February 16th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Technical leaders can be defined as those who are experts in a particular specialty (e.g. engineering, nursing, medicine, finance, law, or accounting), and whose career paths have changed from a technical/individual contributor track to a management track. In many cases, they are promoted to management because of their success as individual contributors – partly as a reward for their history of good work and partly because it is assumed they will teach their direct reports to be as gifted as they are at their technical specialty.
In such situations, it does not take long for problems to arise with newly appointed managers. Direct reports often claim that the new manager is a “micro manager” and they cannot do their work well enough to earn his or her praise. Peers may complain that the new manager is condescending, doesn’t listen, or jumps to false conclusions. Most damaging is when the new manager does not think anything is wrong and dismisses the feedback from his or her colleagues. Left unchecked, these situations often lead to the boss deciding that the “collateral damage” created by these new managers is too great and they are returned to their individual contributor role, ego and reputation badly damaged.
These kinds of situations are entirely avoidable, and this presentation looks at how to identify good candidates for technical leadership, how to spot individuals who are less likely to succeed, and how to work with existing technical leaders to maximize their chances for success.
Tuesday, January 31, 2012
Monday, January 30, 2012
The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?
is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
Friday, January 27, 2012
The Food Safety Modernization Act – What It Really Means (And What It Doesn't)
is being presented by Benjamin L England, Founder and CEO, of FDAImports.com and airs on Wednesday, February 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?
With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.
Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?
With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.
Thursday, January 26, 2012
Who Owns What? Patent Ownership Issues with the Exchange of Biotechnology
is being presented by Kattina V. Barsik, Esq. Intellectual Property and Registered Patent Attorney and airs on Tuesday, February 14th, 2012. For more details, or to register please visit our site at www.fxconferences.com
Institutions involved in the exchange of unique materials – including federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes – often have specific expectations regarding compensation for the help they provide. It may range from acknowledgment in a publication to ownership of inventions made with the aid of the provided material.
Industry defends its commercial interests vigorously, and seeks to offset risk by acquiring and protecting exclusivity in the marketplace through patent law or by use of trade secrets. In contrast, the federal government and its academic grantees look to preserve the flow of ideas for public benefit, primarily through timely publication, and to serve as the public's steward of inventions by preserving the potential for new knowledge to generate a product from which the public may benefit. The exchange of materials between universities and industrial laboratories is often difficult, and unlikely to be standardized in the near future.
This audio conference presentation discusses how to deal with these competing priorities, and craft terms which avoid conflict and allow all parties to benefit.
Institutions involved in the exchange of unique materials – including federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes – often have specific expectations regarding compensation for the help they provide. It may range from acknowledgment in a publication to ownership of inventions made with the aid of the provided material.
Industry defends its commercial interests vigorously, and seeks to offset risk by acquiring and protecting exclusivity in the marketplace through patent law or by use of trade secrets. In contrast, the federal government and its academic grantees look to preserve the flow of ideas for public benefit, primarily through timely publication, and to serve as the public's steward of inventions by preserving the potential for new knowledge to generate a product from which the public may benefit. The exchange of materials between universities and industrial laboratories is often difficult, and unlikely to be standardized in the near future.
This audio conference presentation discusses how to deal with these competing priorities, and craft terms which avoid conflict and allow all parties to benefit.
Wednesday, January 25, 2012
The UK Bribery Act– Upping the Ante on Anti-Corruption/Anti-Bribery Enforcement
is being presented by Jamie L. Kendall, Esq., Senior Director, with Compliance Implementation Services and airs on Thursday, February 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.
In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.
Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.
This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.
Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.
In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.
Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.
This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.
Subscribe to:
Posts (Atom)