is being presented by Tim Ruef, Vice President, of Michael E. Marion & Associates, Inc and airs on Tuesday, May 3rd, 2011. For more details, or to register please visit our site at www.fxconferences.com
One of the biggest challenges facing senior management in life sciences companies is how to identify and recruit top talent, and how best to integrate these new hires successfully into the organization. Human resources professionals have an opportunity to take charge of this process, guiding their hiring managers and earning the respect of corporate leaders.
This audio conference presentation provides attendees with bottom-line, take-home tips on where to find the right kind of talent for your organization, structuring a competitive offer, and the best ways to ensure new recruits are integrated quickly and seamlessly into the company. The speaker provides invaluable information to help HR professionals increase their strategic impact, attract passive candidates, manage top prospects, and strengthen their professional reputation through leadership efforts in this vital area.
Thursday, March 31, 2011
Wednesday, March 30, 2011
Understanding the Abbreviated Pathway for Follow-on Biologics
is being presented by Patricia Carson, Partner, Kaye Scholer LLP and airs on Thursday, April 28th, 2011. For more details or to register, please visit our site at www.fxconferences.com
It has been only a little over a year since Congress passed into law a structured pathway for abbreviated approval of “follow-on biologics”. The follow-on biologics law, which was included as a subtitle of the Patient Protection and Affordable Care Act signed into law on March 23, 2010, is conceptually similar to what is commonly known as the Hatch Waxman Act. Just as Hatch Waxman created an abbreviated pathway for the approval of generic small molecule drugs, the follow-on biologics law creates an abbreviated pathway for generic biologics.
While conceptually similar to Hatch Waxman, the follow-on biologics law differs in a number of respects, reflecting the very different nature of biologics versus small molecules.
This audio conference presentation explores the mechanics of the follow-on legislation and how the branded industry should be preparing for the generic challenges to their branded biologics.
It has been only a little over a year since Congress passed into law a structured pathway for abbreviated approval of “follow-on biologics”. The follow-on biologics law, which was included as a subtitle of the Patient Protection and Affordable Care Act signed into law on March 23, 2010, is conceptually similar to what is commonly known as the Hatch Waxman Act. Just as Hatch Waxman created an abbreviated pathway for the approval of generic small molecule drugs, the follow-on biologics law creates an abbreviated pathway for generic biologics.
While conceptually similar to Hatch Waxman, the follow-on biologics law differs in a number of respects, reflecting the very different nature of biologics versus small molecules.
This audio conference presentation explores the mechanics of the follow-on legislation and how the branded industry should be preparing for the generic challenges to their branded biologics.
Tuesday, March 29, 2011
FDA's 510(k) De Novo Process - Overview and Current Challenges
is being presented by Dr. Zvi Ladin, Principal, with Boston MedTech Advisors and airs on Thursday, April 28th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.
However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.
This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.
Following the enactment of the FDA Modernization Act of 1997, FDA established a new regulatory route for medical devices that present a lower level of risk than Class III and do not have a predicate. ‘De Novo’ applications involve two phases – an initial standard 510(k) process, followed by a review of the risk level of the technology – the De Novo review. The agency committed to completing the second phase within 60 days.
However, things haven't exactly gone according to plan. Until 2007 the average duration of the De Novo review phase was 62 days, with an overall review duration of 245 days. Since 2007 those timelines have stretched to 240 and 482 days respectively – significantly longer than the review of most panel-track, PMA devices.
This audio conference presentation looks at the past, present and future of the De Novo program, how it works, why it hasn't worked as well as expected, and FDA's commitment to review, restructure and streamline the program.
Monday, March 28, 2011
Succession Planning: How to Engage, Retain and Develop Your Best Talent
is being presented by Beth Thomas, Executive VP, Managing Director Consulting Services, with Sequent and airs on Wednesday, April 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
A 2010 Stanford University study found that only about half of the 140 companies surveyed had a candidate-in-waiting to take over as CEO if the need should arise. Other studies have reported similarly sobering statistics. Only 26% of companies have identified successors for the majority of their executive positions (Bersin Factbook, 2009), and 40% of corporate board members are unsatisfied with current succession plans (Egon Zehnder, 2009).
Succession planning is the process of recruiting and grooming employees to fill the key roles within an organization, and companies that engage in strategic succession planning are ultimately more successful. Unfortunately, for many companies succession planning is an overlooked strategy, as the future is set aside in favor of dealing with more urgent priorities. However, companies that fail to plan for succession are putting their very survival at risk. After all, what could be more important than ensuring your leadership positions are filled with the right people? This audio conference provides attendees with the why and how of proper succession planning.
A 2010 Stanford University study found that only about half of the 140 companies surveyed had a candidate-in-waiting to take over as CEO if the need should arise. Other studies have reported similarly sobering statistics. Only 26% of companies have identified successors for the majority of their executive positions (Bersin Factbook, 2009), and 40% of corporate board members are unsatisfied with current succession plans (Egon Zehnder, 2009).
Succession planning is the process of recruiting and grooming employees to fill the key roles within an organization, and companies that engage in strategic succession planning are ultimately more successful. Unfortunately, for many companies succession planning is an overlooked strategy, as the future is set aside in favor of dealing with more urgent priorities. However, companies that fail to plan for succession are putting their very survival at risk. After all, what could be more important than ensuring your leadership positions are filled with the right people? This audio conference provides attendees with the why and how of proper succession planning.
Wednesday, March 23, 2011
Fixing U.S. Renewable Energy Policy - Lessons from Germany
is being presented by Christoph Stefes & Frank N. Laird, Associate Professors, with University of Colorado Denver and airs on Thursday, April 21st, 2011. For more details or to register, please visit our site at www.fxconferences.com
Starting around 1990, Germany began promoting renewable energy with aggressive and consistent policies and, despite its weak renewable resources, became a leading country in terms of both renewable energy installations and manufacturing. Around the same time, United States policy makers began debating greater support for renewable energy but never got onto a new policy path, providing instead weaker and volatile policy supports for these technologies.
Germany adopted an innovative policy instrument, the feed-in tariff, now popular almost everywhere except in the United States. The U.S., in contrast, seemed both technologically and institutionally poised to become a leading renewable energy country, but failed to do so, in part because of inconsistent and short-term policies at the national level. Much of the progress in the United States has been driven by policies at the state level.
In this audio conference, we examine the different paths and divergent outcomes in renewable energy policy in the U.S. and Germany, and discuss how a consistent, long-term vision is needed before the United States can regain its competitiveness in this area.
Starting around 1990, Germany began promoting renewable energy with aggressive and consistent policies and, despite its weak renewable resources, became a leading country in terms of both renewable energy installations and manufacturing. Around the same time, United States policy makers began debating greater support for renewable energy but never got onto a new policy path, providing instead weaker and volatile policy supports for these technologies.
Germany adopted an innovative policy instrument, the feed-in tariff, now popular almost everywhere except in the United States. The U.S., in contrast, seemed both technologically and institutionally poised to become a leading renewable energy country, but failed to do so, in part because of inconsistent and short-term policies at the national level. Much of the progress in the United States has been driven by policies at the state level.
In this audio conference, we examine the different paths and divergent outcomes in renewable energy policy in the U.S. and Germany, and discuss how a consistent, long-term vision is needed before the United States can regain its competitiveness in this area.
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