Thursday, March 31, 2011

Finding, Recruiting and On-Boarding Top Talent in the Life Sciences

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.

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.

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.

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.

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.

Tuesday, March 22, 2011

Companion Diagnostics - What Pharma Needs to Know About IVDs

is being presented by David Kern, Senior Director, RAC MBA and airs on Wednesday, April 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com

If you are contemplating a companion diagnostics program, or if you already have such a program in place, you need to live in both the drug and diagnostic worlds. One key component to securing FDA approval – and staying in compliance – is understanding how in vitro diagnostics are regulated. Is your test a 510(K) or a PMA? What is the difference between an LDT and an IVD? Does FDA care about ISO standards and certification? This audio conference presentation reviews the current regulatory landscape for IVD tests, as well as lab-developed tests and companion diagnostics, focusing on the things pharma companies need to know.

Monday, March 21, 2011

Understanding and Implementing the New EU Annex 11

is being presented by Dr. Ludwig Huber, Director, with LabCompliance and airs on Tuesday, April 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com

After more than 15 years the EU has released a new final version of Annex 11. Together with the updated EU Chapter 4 on documentation, it forms the EU equivalent to FDA's Part 11. Compared to the older version, it has more details and some very specific requirements. It addresses the regulatory needs of modern IT equipment, and when implemented correctly, it also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments.

This audio conference presentation provides attendees with an overview and a good understanding of the Annex 11 requirements, and also provides recommendations and tools for cost-effective implementation.

Friday, March 18, 2011

FCPA: Critical Issues and Best Practices for Life Sciences Companies

is being presented by Richard C. Smith & John E. Kelly, Partners, with Fulbright & Jaworski LLP and airs on Thursday, April 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The U.S. Department of Justice (DOJ) leadership has announced at every opportunity that it is targeting the health care industry for FCPA violations, with a particular focus on pharmaceutical and medical device companies. In 2010, the DOJ followed through on its warnings to the health care industry by notifying at least a dozen pharmaceutical companies that they were under investigation for potential FCPA violations. While FCPA compliance is complex for all industries, the health care industry faces unique FCPA compliance challenges.

This presentation provides an overview of the U.S. Foreign Corrupt Practices Act, as well as other anti-bribery statutes like the new UK Bribery Act, and discusses the impact they have on companies doing business on a global scale. Our speakers review some of the recent investigations and enforcement trends in the life sciences industry, and suggest strategies for mitigating the risk associated with global business practices.

Thursday, March 17, 2011

Software Selection for Critical, High-Risk and Regulated Systems

is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Software vendors hate to deal with knowledgeable system selection teams. It makes their job of selling more difficult and creates more work for them. But that’s their problem. Your problem is identifying the best software solution to meet your company’s business needs, and ensuring a successful system implementation. How do you do this? By having a defined selection process whereby you understand and define what your company needs before selecting the software, have the vendors demonstrate their ability to fulfill your company’s needs in terms of functionality and service, and define the implementation project in detail before signing any agreements.

This audio conference presentation reviews the essential steps for system selection, as well as the additional steps required for critical and high-risk systems, or those that must be compliant with various regulations.

At the end of the project, your company and users have to live with the system. Learn how to make sure your company gets what it needs, and not just what the vendor wants to sell.

Wednesday, March 16, 2011

Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update

is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.

This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.

This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.

This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.

Monday, March 14, 2011

Increased FDA/CMS Coordination: What it Means for Industry

is being presented by Dr. Edward E. Berger, Principal and Founder, with Larchmont Strategic Advisors and airs on Tuesday, April 12th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Efforts to improve communications and coordination between FDA and CMS, including an initiative to implement a formal program for parallel review of new products by the two agencies, have sparked industry concern over the potential blurring of the heretofore bright line between the FDA’s market clearance function and CMS’ responsibility for Medicare coverage and payment determinations. This concern is compounded by the absence of established mechanisms at CMS for the safeguarding of company confidential information contained in regulatory submissions.

This audio conference presentation looks at the present status and likely outcomes of FDA/CMS interagency coordination efforts, and evaluates the opportunities as well as the threats posed by those efforts to developers of new therapeutics, devices and diagnostics.

Friday, March 11, 2011

Time Management: Achieving More in Less Time

is being presented by Lorna Riley, President, with Chart Learning Solutions and airs on Thursday, April 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com

It's a common refrain – too much to do, not enough time to do it. So if there aren't enough hours in the day, why not add a couple?

With shrinking workforces, rising expectations, and “I need this yesterday!” work demands, stress is at an all-time high. When people are overloaded with work, they’re nervously cautious. The result is low productivity, low morale, and rising frustrations.

This audio conference shows how you can build two more hours of productivity into your day, reduce stress, and discover your full potential by eliminating time-wasters and scheduling your time for maximum payoff. If you've ever found yourself trying to manage multiple “A” priorities, deal with interruptions, meet deadlines on time, and schedule tasks in a constantly changing work environment, this audio conference is for you. Lorna Riley delivers a high-content, fast-paced, and soul-searching session that inspires an immediate increase in productivity, renewed work enthusiasm, and bottom-line results for you and your organization.

Thursday, March 10, 2011

Industry Update: Federal and State Aggregate Spend Requirements

is being presented by John Patrick Oroho, Principal, Porzio, Bromberg & Newman, P.C. and airs on Wednesday, April 6th, 2011. For more details or to register, please visit our site at www.fxconferences.com

The Physician Payment Sunshine Act became law as part of healthcare reform measures in 2010. Life science companies are now required to track, aggregate and disclose the amount they append on physician payments and transfers of value and gifts (i.e. meals, etc.). Federal regulations for the Sunshine Act are to be promulgated by October 2011. However, since spend transactions need to be captured for federal reporting purposes beginning on January 1, 2012, it is necessary to start to preparing before the regulations are published.

At the same time, several state legislatures are also establishing and passing their own laws which influence how life science companies can carry out business in those locales.

In this audio conference presentation we look at what type of information will need to be captured and reported pursuant to the Sunshine Act. The speaker also provides an update on state activities, with information relating to drug samples, laws governing lobbying, and other local regulations of particular concern to life science companies.

Tuesday, March 8, 2011

The Continuing Evolution of Clinical Research in India

is being presented by Dr. Vijai Kumar & Dan McDonald, President/Chief Medical Officer & Vice President Business Strategy, with Excel Life Sciences and airs on Tuesday, April 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.

Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.

Monday, March 7, 2011

Navigating Healthcare Reform from the Employer's Perspective

is being presented by Bill Hutter, Founder & CEO, of Sequent, Inc. and airs on Tuesday, March 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Did you know that the new Healthcare Reform legislation has 514 NEW provisions and no less than 20 changes to the Internal Revenue Code? EVERYONE will be affected. There are many nuances to the legislation that can be interpreted in different ways. This audio conference presentation provides employers with the information they need to prepare for these changes, and looks at both the short- and long-term ramifications. Our speaker touches on general HR concerns regarding the new legislation, and advises attendees on what their companies should be doing right now to get ready. Attendees will gain an increased understanding of the specific changes being considered, all the alternatives, and valuable insight into the best scenarios and options.

Wednesday, March 2, 2011

Using Baldridge Criteria to Improve Business Performance

is being presented by Sherry Bright, VP, Clinical & Performance Improvement, with VHA Mountain States and airs on Wednesday, March 23rd, 2011. For more details, or to register please visit our site at www.fxconferences.com

Catalyzed by health care reform, driven by the pressing need to significantly bend the cost curve, the health care delivery system is transforming itself. Suppliers to providers will need to remake themselves, as well, to be chosen as the highest value provider of services, materials and devices.

This presentation describes a systemic approach to organizational improvement that has been proven to result in increased market share, stronger customer relationships and, ultimately, higher profitability. Using examples from leading life sciences companies like Medrad, our speaker examines strategies already in place that have assured strong line-of-sight between leadership and customer. The presentation addresses how organizations can assess their own strategies and begin to build more effective models that will support gains in customer share.

Tuesday, March 1, 2011

The FDA and Social Media

is being presented by Kelly Savage Day, Senior Associate, with Sedgwick, Detert, Moran & Arnold LLP and airs on Thursday, March 31st, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

In this brave new world of Twitter, Facebook, LinkedIn and other social media websites, risk and opportunity may be combined. There is no question that social networking represents the emergence of a tremendous marketing and customer education opportunity, but there are also pitfalls for the FDA-regulated company. What happens if you go too far, say too much? Do you need to be concerned about the use of these networking sites by employees?

This audio conference presentation tackles some of the important issues that social media poses for life science companies – the benefits, risks, and mitigating that risk – and provides insight on how to use social media to positively impact your business, without running afoul of regulators.