Archive for May, 2008« Older Entries
May 29 – 30, 2008 • Crowne Plaza Downtown • Houston, Texas
Overcoming the Workforce Deficit in Oil and Gas with Innovative Strategies to Recruit, Retain and Develop New Talent.
Attend this Conference to:
• Explore current recruitment strategies and ways in which they can be applied to your business
• Examine industry best practices for retaining, developing and promoting
your most valuable employees
• Understand the psychology and the wants and needs of Gen-X and Gen-Y to
develop strategies for integrating their work style with those of baby boomers
• Establish methods for effective technical and knowledge transfer
• Learn about the crucial roles safety and proper technical training play
in the workplace
• Gain insight into recruiting non-traditional candidates and how established
programs have proven extremely beneficial to these new employees
as well as the companies who employ them
According to several published studies, the average oil and gas employee is now approximately 50 years old. With most baby boomers retiring in the next 5-15 years, how are oil and gas companies equipped to handle rapidly growing energy demands with a decreasing workforce?
Extensive layoffs, mergers and acquisitions in the 1980’s and 1990’s, and the general reputation of oil and gas as unprogressive have contributed to Gen-X and Gen-Y workers shying away from the industry. Grasping the seriousness of the labor shortage, many universities and companies have begun to work together to actively recruiting a younger workforce. Initiating internship and mentoring programs at and between universities and industry, employing innovative recruitment and retention practices, and providing in-depth technical training are some of the significant steps that this industry is taking to overcome the critical talent issue.
Attend ACI‘s inaugural Talent Succession in Oil & Gas Summit to learn best
practices for recruiting and retaining employees, the importance of technical and safety training and knowledge transfer, and how to integrate the work styles of Gen-X and Gen-Y with that of baby boomers.
Speaker faculty includes Senior-Level Executives from Shell, Chesapeake Energy, Entergy, American Petroleum Institute, Midland College, University of Oklahoma, and Fort Valley State University.
Maximize your educational experience by registering for our interactive
pre-conference workshop Understanding Gen-X and Gen-Y – Insights Into
Recruiting and Retaining the Next Generation of Workers. Seize this opportunity to network with top industry professionals while getting practical real-life strategies on how to deal with this complicated and continuously evolving issue.
Gain invaluable insight and network with professionals from:
American Petroleum Institute
Fort Valley State University
University of Oklahoma
Partnership Strategies, LLC
The FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of the FFDCA in decades. Preeminent members of the nation’s Food and Drug bar will drill you in the basics of FDA law and regulation — and the nuances of FDAAA — as they help you:
• MASTER the basics of the application and approval processes for drugs, biologics and devices
• COMPREHEND the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
• DEVELOP a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices
• LEARN how devices are classified, monitored, and regulated
• UNDERSTAND the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
• RECOGNIZE the pivotal role of labeling in the drug and biologics approval process
• NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls
• GAIN a clear understanding of the laws and regulations controlling the advertising, marketing and promotion of drugs, biologics and devices
The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports…patent concerns…exclusivity… All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And recent court cases and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The same can be said of securities experts and business executives in the life sciences arena.
Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods. However, many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.
Boost your FDA regulatory IQ. Develop expertise in the FDA approval process and the ins and outs of post-approval challenges. ACI’s FDA Boot Camp has been designed to give products and patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA competencies, including the nuances of FDAAA.
A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:
• The organization, jurisdiction, functions, and operations of the FDA
• The essentials of the approval process for drugs, biologics, and
- NDAs – OTC Approval
- INDs – 510(k) submissions
- BLAs – PMA process
• Clinical trials for drugs and biologics and the clearance process
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Act in the patenting of drugs
• Labeling in the drug and biologics approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring and signal detection
• Requirements for post-approval advertising and promotion
• Recalls, product withdrawals, and FDA oversight authority
• Current government enforcement priorities and key legislative initiatives
Other program highlights include special Patent and Medical Device tracks.
Leveraging Wireless Technology for Chronic Disease Management Leveraging Wireless Technology for Chronic Disease Management
Mobile Solutions and Strategies to Encourage Patient Self-Management to Improve Healthcare Delivery and Reduce Costs
Attend this conference to:
■ Explore new trends in use of wireless technologies for chronic disease management
■ Capitalize on the key business drivers to help establish your company in the mobile healthcare arena
■ Understand the perspectives of healthcare providers and insurance companies to gain their buy-in and encourage adoption
■ Evaluate new viable economic models for reimbursement
■ Learn best practices for implementing self-management programs for diabetes and cardiac patients
■ Identify cost reduction strategies for both the patients and healthcare providers using preventative techniques
■ Understand how leveraging electronic medical records can aid in chronic disease management
Healthcare costs continue to escalate, while the quality of care for many declines. Mobile technology represents a very real opportunity to improve not just the quality of care for many chronic disease sufferers, but a chance for healthcare providers to become more efficient and dramatically cut costs.
Given that value proposition, stakeholders are exploring the business case behind healthcare technology and a number of important pilot studies have been undertaken. But many issues need to be resolved before the industry will see commercial solutions become commonplace. Communication and dialogue between the key players – from healthcare providers to insurance companies to policy makers to the mobile solution providers – is crucial. And given the increasing trend towards consumer driven healthcare, as patients of all ages are eager to take a more proactive role in their health, the time is ripe to drive forward the adoption of mobile healthcare solutions.
In response to market demand, ACI has developed a unique educational forum, ‘Leveraging Wireless Technology for Chronic Disease Management.’ No where else will you learn the steps being taken to advance chronic disease management using wireless technology. This is your opportunity to learn first-hand how industry experts are using wireless technology to combat diseases on the rise such as diabetes and asthma. Amongst our distinguished speaker faculty, case studies will be presented by:
• Vince Kuraitis, the principal of Better Health Technologies will share his insights on the emerging trends amongst wireless healthcare technology
• Dr. James Mault, director of new business development and products within the health solutions group at Microsoft will show how electronic records can enable patients to better manage their chronic diseases
• Dr. Dena Puskin, director of the office for the advancement of telehealth, US Department of Health and Human Services will look at the cost effectiveness telemonitoring programs in rural areas
• Peter Boland, director of business development at BeWell Mobile will highlight the work that his organization has done with large non-profit healthcare providers such as Kaiser
• Paul Nice, vice president of federal health programs at UnitedHealth Group will participate in a panel discussion on new reimbursement models
• Aaron Goldmuntz, director of business development at CardioNet will demonstrate how they were able to implement an innovative tool to help physicians better manage cardiac patients
In addition, learn how to set up testing protocols for your wireless medical devices in our two pre-conference workshops: Testing your Device through Accurate Data Collection and Methodology and The Basics of Raising Capital for your Start-up Venture.
Gain an in-depth understanding of the FCPA and learn how to minimize the risk of non-compliance.
All companies engaging in international business, large and small, must develop and implement an FCPA compliance policy and training program to protect themselves against FCPA violations.
Having an effective and comprehensive corporate FCPA compliance policy in place will demonstrate to employees and, if necessary, law enforcement officials that your company considers anti-corruption compliance an important corporate goal. If done properly, a comprehensive compliance program can become a valuable corporate asset that enhances company operations, facilitates compliance with law and mitigates damage when and if violations occur.
For the first time in Chicago, this highly rated American Conference Institute FCPA Boot Camp will provide you with an excellent working knowledge of the Foreign Corrupt Practices Act and strategies you need to successfully implement and monitor an effective anti-corruption compliance program.
Topics will include:
-Creating a Code of Conduct that matters
-Tailoring FCPA training to the company
-Dealing with violations
-Screening and documenting potential business partners
-Developing effective anti-corruption training programs
-Performing anti-corruption risk assessments
-FCPA books and records requirements
Throughout the course, you will have ample opportunity to ask questions and to learn from and compare notes with your peers. Whether you are new to the area or just need a comprehensive refresher, this FCPA Boot Camp will
provide you with the foundation you need to ensure your company’s FCPA compliance.
May 28th, 2008
in International Trade & Defense |
Get the Latest Insights on:
• What DDTC, BIS and OFAC expect from an “effective” export compliance program
• Getting management and board buy-in to comply with the letter and spirit of the law
• Minimizing diversion risks in export and reexport transactions
• Developing an effective licensing strategy for China
• Balancing U.S. dual national rules with Canadian human rights and privacy laws
• Managing an effective restricted parties screening program
• What to do if you uncover a potential export controls or sanctions violation
• Meeting tougher and broader U.S. sanctions requirements
• Controlling the flow of technology in a globalizing services and R&D environment
• Developing a solid de minimis strategy
• Meeting CFIUS and national security requirements for foreign investment
PLUS an update on China’s encryption controls, and EU’s export controls
and sanctions regimes.
The United States continues to take a more aggressive approach to enforcement in all areas of international trade regulation and national security. The Departments of State, Commerce, Treasury and Homeland Security are vigorously policing the export activities of U.S. firms and their foreign trading partners to ensure strict compliance with export control and economic sanctions laws. Rising government expectations and new regulatory standards amplify risks for U.S. and foreign companies in our increasingly global business environment. Export controls are becoming ever more complex and restrictive, and U.S. exporters must develop robust internal export control compliance programs that do not unduly hamper legitimate trade and also comply with U.S. and local laws.
Now in its 11th successful year, ACIs’ National Forum on Export Controls is the event that export professionals rely on for comprehensive, insightful, and practical guidance on critical global export compliance issues. Benefit from the practical perspective of seasoned corporate export compliance executives from companies such as General Electric, Tyco, Citigroup, ITT, Baker Hughes, Dresser, Boeing, United Technologies and SAIC. Get an update on regulatory and policy initiatives from top Government officials and learn how industry is setting up internal controls to comply in this constantly changing global legal landscape. This year’s agenda will include the latest information on:
• What qualifies as an “effective” program: what DDTC, BIS and OFAC expect from an export compliance program
• Spotting and addressing transshipment and diversion risks
• Screening to mitigate risks beyond export control and sanctions compliance
• Best practices for EAR licensing to China
• Determining when and how to make CFIUS filings
• Protecting your data at every stage of your outsourcing relationships
• Deciding whether, how and when to make a voluntary disclosure.
Participants will also receive a comprehensive set of materials prepared by the speakers for the conference. These are
invaluable reference materials which you will use again and again long after the conference is over.
May 20th, 2008
in Pharmaceuticals / Biotech / Life Sciences |
Intensive training in the essential pricing concepts and methodologies
related to VA, DoD, PHS, and Coast Guard programs.
Pricing experts will lay out the fundamentals of “Big Four” pricing and pharmacy benefits programs in a logical, easy-to-understand format and will provide essential training on how to:
FEATURING EXPERT GOVERNMENT INSIGHTS FROM:
• NAVIGATE the intricacies of the jurisdiction, functions and operations of the Department of Veterans Affairs
• NEGOTIATE the FSS contract price
• CALCULATE non-FAMP and FCP
• CORRECT pricing anomalies
• SECURE national contracts and blanket purchase agreements
• COMPLY with VAOIG and agency regulations
The U.S. government spends billions of dollars per year on the purchase of drugs making it one of the largest purchasers of pharmaceuticals in the U.S. Sales to the government typically account for a large portion of a company’s total revenue, and a company cannot remain competitive in today’s market without selling to the government. As pharmaceutical manufacturers’ revenue and profits are so closely tied to government contracts and pricing, it is essential to have a thorough understanding of the Veterans Health Care Act, Federal Supply Schedule Contracting, Federal Ceiling Price, andpharmacy benefits programs.
While having the government as a client is lucrative, it can be costly, time consuming and confusing. Understanding the basics and key terms of “Big Four” pricing is necessary to ensure that companies do not enter into price contracts that obligate them to comply with impossible terms. Selling to the VA, DoD, PHS and Coast Guard also requires constant price calculations and price reporting. These calculations are often perplexing and result in price anomalies that can leave even the most seasoned contracting practitioner baffled. On top of complying with the “Big Four’s” numerous rules and regulations, companies must also evaluate how their “Big Four” prices affect their overall pricing.
Master the essentials of key “Big Four” pricing concepts and methodologies
ACI’s “Big Four” Pharmaceutical Pricing Boot Camp has been designed to give novices and experienced practitioners alike a complete understanding of core pricing competencies. ACI has assembled a faculty of the government authorities on “Big Four” pricing and pharmacy benefits programs along with expert pricing practitioners. This distinguished faculty will make sense of complicated terminology and pricing calculations and teach you how to navigate the complexities of working with the “Big Four” agencies.
Attendees will also benefit from the extensive written materials prepared by the speakers especially for this conference.
May 20th, 2008
in Pharmaceuticals / Biotech / Life Sciences |
Minimizing Risk, Maximizing Patent Value, and Avoiding Anticompetitive Behavior.
Leading in-house pharmaceutical counsel, government regulators, and expert attorneys will provide practical advice on how to successfully tackle the most complex antitrust issues facing brand-name and generic pharmaceutical companies, including insights on how to:
• NEGOTIATE patent settlements and reverse payments that withstand antitrust scrutiny
• EVALUATE strategic alliances and collaborative agreements for anticompetitive risk
• STRUCTURE M&A deals that expand your portfolio and minimize antitrust exposure
• CRAFT compliant, indisputable pricing and distribution arrangements
in a changing marketplace
• REVISE your life cycle management strategies in light of recent FTC
antitrust policy initiatives
• DEFEND against class action suits and other complex antitrust litigation
Current pressures on the pharmaceutical industry, combined with lurking exposure to antitrust risk and liability, create an environment ripe for enforcement and litigation. Determining the bounds of anticompetitive behavior has never been more vital.
At a time when pharmaceutical companies are scrambling to rejuvenate their product lines while still commanding a market share, pharmaceutical counsel find themselves still searching for answers…Will the Supreme Court ever take a case that will bring final resolution to reverse settlement payments or will Congress succeed in resolving this issue first? What effect will recent case law have on pharmaceutical pricing and distribution schemes? These are only a few
of the issues that should be on your antitrust radar.
Maintain the balance between IP and competition while
avoiding antitrust scrutiny
The ability to operate within a set regulatory framework is essential to ensuring business and strategic goals are met. Structuring transactions and deals in a manner that will pass regulatory muster requires a quick resolution of issues raised and an in-depth understanding of what the current status of the law is.
Dedicated solely to helping you – both brand name and generic manufacturers – understand what the current status of the law is in the pharmaceutical antitrust arena, the American Conference Institute’s 4th Annual In-House Counsel Forum on Pharmaceutical Antitrust will bring you the most up-to-dateinformation on the industry’s latest antitrust dilemmas, while also providing you with practical, proactive solutions for navigating this high-scrutiny environment.
Expert faculty of government regulators and pharmaceutical
Featuring an FTC Keynote Address by Commissioner Jon Leibowitz, and several Spotlight Addresses from the FTC and DOJ, this conference boasts a faculty of government regulators unmatched by any other Pharmaceutical Antitrust conference on the market!
Also, add value to your experience by attending our Master Class on Navigating the Pharmaceutical Merger Process, which will offer an in-depth examination of the merger process and how to structure your deals in a manner that will not raise anticompetitive concerns.
May 15-16, 2008 • Rio All-Suite Hotel & Casino • Las Vegas
Expert Strategies for Litigating, Settling and Managing the New Wave of Asbestos Claims.
Featuring Two Bonus Sessions:
Claims Migration: Tort Reform and the Evolving Jurisdictional Landscape
Hon. Mark Davidson
Texas MDL Asbestos Judge
11th District Court
Michael L. Armitage
Managing Partner, Los Angeles Office
Waters & Kraus, LLP
Asbestos Settlements: Obtaining the Best Outcome for Your Client
Hon. James Robertson
San Francisco Superior Court
Edward R. Hugo
Brydon Hugo & Parker
Dean A. Hanley
Paul & Hanley LLP
Between recent tort reforms in key jurisdictions and new theories of liability in asbestos litigation, the old rules no longer apply. Plaintiffs’ and defense counsel, as well as in-house counsel for insurers, reinsurers, property owners and other companies likely to face the new round of asbestos claims, must be prepared.
American Conference Institute’s 9th National Asbestos Claims event will
provide you with the most-up-to-date knowledge, strategies, and expert advice that you need to:
• Prepare for new theories of liability and new classes of defendants,
including claims against manufacturers of products that do not contain
asbestos and “take-home” premises liability exposure claims
• Benefit from recent tort reforms and changing causation standards
in key jurisdictions
• Use the latest information from the medical frontier to your advantage
• Resolve conflicts and improve communication among insurers,
policyholders, and defense counsel
• Understand the impact that bankruptcy trusts have on asbestos claims
and analyze the viability of bankruptcy alternatives
• Master discovery, jury selection, and trial strategies to build a winning case
• Accurately assess and manage future liabilities
New claims, new defendants, and new jurisdictions . . . Are you prepared for the challenges and opportunities of the evolving asbestos landscape?
May 15th, 2008
in Legal Conferences |
May 15-16, 2008 • The Hotel Whitcomb • San Francisco, California
Strategic Approaches for Minimizing Exposure and Mitigating Damages. Protect yourself from becoming the next insurance company to be slapped with a multi-million dollar bad faith verdict.
Gain focused analysis, case law updates and winning strategies from leading litigators and key industry professionals on:
• Preserving attorney-client privilege in light
of recent decisions
• Personalizing the insurance company and persuading
an unsympathetic jury
• Evaluating potential exposures for bad faith claims
involving SIRs and large deductibles
• Preventing bad faith litigation between excess
and primary carriers
• Efficient and cost-effective techniques for mediation
to ensure resolution
• Recent legislative and litigation developments around
the country and the implications for your jurisdiction
With more and more states enacting bad faith statutes, plaintiffs are continually presenting new challenges to insurance companies. Even in states with a long history of bad faith litigation, the law is constantly changing. To stay on top of winning (and losing) approaches in this volatile arena, you need to network, learn from and analyze the past year’s cases with your colleagues and adversaries.
At American Conference Institute’s 17th National Advanced Forum on Bad
Faith Litigation, bad faith luminaries will share insights and practical strategies that capitalize on recent decisions and rulings. Our exceptional faculty of experienced in-house professionals and seasoned private practice attorneys present on the frontlines will provide you with vital information for success.
WHO YOU WILL MEET
Insurance Industry Professionals including:
• Corporate Counsel
• Claims Managers
• Compliance Officers
• Risk Managers
Attorneys Specializing in:
• Insurance Bad Faith
• Extra-Contractual Damages
• Insurance Defense
• Personal Injury
• Worker’s Compensation
• Life, Health and Disability
This comprehensive and information-packed event is one you cannot afford
to miss! Take this opportunity to get your questions answered by some of the leading bad faith litigators and to network with your peers and colleagues from around the country.