Archive for July, 2008
ITAR COMPLIANCE
July 23rd, 2008
in International Trade & Defense |
Get the Latest Insights on:
• UK-US and Australia-US treaties for defense articles and services
• Dealing with DDTC-mandated independent audits in the context of voluntary
and directed disclosures
• Reducing the risk of technical data and defense services export violations
• Dealing with the State Department: How to maintain good relations
and what to do if you don’t
• Voluntary disclosures: Investigation process and how to meet DDTC’s
revised rules and rising expectations
• Minimizing successor liability risks in ITAR acquisitions
• Complying with end-use and end-users restrictions
• Developing a successful foreign nationals control program
• National security considerations under the ITAR
Is Your Export Compliance Program Meeting the Latest Defense
Trade Controls Requirements?
Recent cases including the ITT and Northrop Grumman agreements send a clear message that exporters must be vigilant about preventing, detecting and investigating potential ITAR controls violations. Companies that deal with ITAR-controlled items or technical data must ensure that export practices and global supply chains are compliant with U.S. trade law. Creating an adequate ITAR compliance program is complex and U.S. exporters must be up to date on the latest developments and enforcement initiatives of defense trade controls. For this critically acclaimed “3rd National Forum on ITAR Compliance”, the American Conference Institute has once again assembled an exceptional faculty of top business, legal and government officials. This advanced forum will provide attendees with an update on civil and criminal ITAR enforcement, state of the art licensing and compliance practices as well as practical advice on how to successfully implement ITAR controls. Hear practical corporate perspectives on how best to comply in a era of increased scrutiny, including:
• How U.S. persons can engage in ITAR-controlled defense services by simply providing public domain information
• Hiring and assigning foreign persons in ITAR sensitive areas
• ITAR contamination: when non-U.S. technology becomes tainted
• DDTC’s compliance expectations in the acquisitions/merger context
• Handling mistakes by downstream recipients of U.S. defense articles
• Factors triggering DDTC requirement of an independent audit
• Key elements and “best practices” of effective ITAR compliance
Tags: DDTC, export compliance program, ITAR, Legal conferences, u.s. trade law
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Diacetyl and Food Flavorings
July 19th, 2008
in Healthcare, Litigation, Pharmaceuticals / Biotech / Life Sciences |
June 19 & 20, 2008 • Grand Hyatt • San Francisco, CA
Understanding the Scientific, Regulatory and Legal Aspects of Diacetyl and
Flavorings Use.
Get highly-specialized, practical information on:
• Sources, uses and manifestations of flavorings and the potential health
complications that can arise
• Making – or breaking – the causal link between flavorings exposure
and the development of bronchiolitis obliterans (so-called “popcorn lung”)
• The first consumer lawsuits: how recent cases in Colorado and Florida
are changing the flavorings litigation landscape
• Understanding the complexities of litigating cases where worker third-party
claims and workers’ compensation are involved
• Assessing qualifications, credibility and testimony of medical experts
in the case for successful depositions and testimony at trial
• Calculating ongoing damages through accurate assessment of costs of care
• Regulatory action: coming standards from OSHA and Cal-OSHA,
plant inspections, possible banning of diacetyl, and more
Litigation over diacetyl has nowexpanded beyond popcorn factory workers to consumers, and to workers with other types of food products… Do you have all the information you need to advise or protect your client?
With extensive media coverage of emerging consumer lawsuits and growing public awareness of a link between diacetyl and respiratory complications, there’s no doubt this litigation will continue to grow. Add to that the fact that there are currently cases all over the country involving workers who work at plants that make or use diacetyl and related flavorings, and it becomes clear that it’s a critical time for food and flavorings industry counsel and risk managers and their advisors to ensure you have all possible medical and legal information at your fingertips to minimize risk and liability due to flavorings use going forward.
That’s why American Conference Institute developed this conference on
Diacetyl and Flavorings: Understanding the Scientific, Regulatory and Legal
Aspects of Diacetyl and Flavorings Use. For this unique event, we’ve assembled
a multi-disciplinary faculty of epidemiologists, food scientists, in-house counsel,
key regulators and top litigators in the area, in an agenda that covers all the key
complex scientific and legal issues that arise in litigating and settling these
complex cases.
Don’t miss this unique opportunity to hear what others are doing in response
to the managing the changes and challenges of diacetyl use and the associated
litigation risks. Get your questions answered and get valuable tips and takeaways you can implement back at the office. Spaces will go quickly, so register now for this important event. We look forward to seeing you in San Francisco in June.
Tags: Consumer Lawsuits, Legal conferences, Litigation strategies
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7th Annual Advanced Forum on Preventing, Managing and Defending Claims of Obstetric Malpractice
July 17th, 2008
in Healthcare, Litigation |
June 17&18, 2008 • Hilton Boston Financial District • Boston, MA
Featuring:
✓The appropriate standard of care in emergency situations, such as
shoulder dystocia, emergency c-section and other emergencies
✓Critical information on how to report a bad outcome to hospital
perinatal committees and insurers
✓Using placental pathology and neuroimaging to determine
the timing of the injury – so you can determine if professional
negligence really was the cause of it
✓Premature delivery: identifying, preventing and minimizing
adverse outcomes
✓Understanding the basis of neonatal brain injury
✓Evaluating damages: assessing life care plans,
structured settlements and more
✓Screening for fetal anomalies and genetic disorders –
and communicating the results effectively
Why do so many legal and medical professionals regularly attend this popular national event?
Because our outstanding faculty of leading medical and legal experts
provides the full picture for preventing and managing these complex claims.In an environment where damages can soar over the $100 million mark,
it’s key for professionals involved in obstetric care to have up-to-the-minute
medico-legal information on obstetric malpractice lawsuits. Get valuable
information you can really use to assess causation, standard of care and
damages, and to prevent and defend these complex, expensive claims.
This conference is your best opportunity to get answers to your questions
from medical practitioners and lawyers on the front lines.
Who Attends This Event?
This unique event attracts plaintiff and defense lawyers, hospital risk
managers/doctors, nurses and professional liability insurers. Why? Because
we’ve developed an event that tackles the issues from both medical and legal
perspectives, to give you the full picture – not just bits and pieces of it. (Just
look at the highly-experienced, diverse faculty we’ve assembled for the event.)
• Lawyers who litigate medical malpractice cases (both plaintiff and
defense) come to get a solid grounding in the medical issues upon which
the case is based – which is so critical to getting the best result for your
client in a medical malpractice case. The practical strategies and tips from
the lawyers on the faculty who bring and defend these cases regularly are
extremely valuable.
• Doctors, nurses and hospital risk/quality assurance managers come to
the event to assess whether their practices measure up, and to obtain
strategies for dealing with every hospital’s and doctor’s nightmare of
having to defend an obstetric malpractice case with a significant
catastrophic injury to a baby.
• Insurers come to get valuable tools for assessing professional negligence
claims and gaining medical information, understanding litigation
strategies, and evaluating hospital risk management techniques.
Whether you are a medical professional, medical liability insurer, or lawyer,
you’ll come away with valuable information that will enable you to minimize
risk going forward and better manage and defend these complex claims. Spaces
go quickly every year – so register now. We look forward to seeing you in
Boston in June.
Tags: Legal conferences, Litigation strategies
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Pharmaceutical and Medical Device Manufacturers’ Guide to OFF-LABEL COMMUNICATIONS
July 16th, 2008
in Healthcare, Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
Practical strategies for protecting your company in a climate
of heightened government scrutiny
Compliance officers, corporate counsel, MSLs and leading practitioners will share their best practices and insights on how to:
• IMPLEMENT the FDA’s proposed guidance on scientific reprints
• CREATE a compliance/training program which takes into account what sales reps actually face in the field
• INCORPORATE lessons learned from recent government enforcement actions into compliance policies and procedures
• CONDUCT an internal investigation to uncover off-label violations
• MINIMIZE product liability risks in off-label usage situations
Government enforcement agencies are cracking down
on off-label violations
Pharmaceutical and medical device manufacturers continue to be in the
government’s crosshairs. Since 2004, there have been eleven off-label related cases settled with the government, and it is estimated that there are still 100 more cases in the pipeline. Enforcement agencies have warned that off-label marketing will continue to be a focus of anti-fraud enforcement efforts over the next several years and medical device companies will face particularly aggressive prosecution. In addition to government enforcement efforts, manufacturers must also contend with “creative” theories of liability being put forth in civil lawsuits. The lower court decision in Clark v. Pfizer Inc, wherein the court held that a manufacturer of an innovator drug is liable for off-label generic use, was a major departure from existing case law and will be a huge blow to manufacturers if upheld.
Prepare to deal with the increased scrutiny
Understanding the distinction between what is and is not permissible regarding off-label promotions is important. But, what companies really struggle with is how to stop off-label violations from happening. With that in mind, the focus of this year’s Guide to Off-Label Communications is on the practical application of case law and guidelines. Our faculty of experts will provide concrete examples of how to deal with problematic sales activities and how to create and enforce compliance policies that truly work. In addition, there will be a strong emphasis on government enforcement trends, managing government investigations, and government settlement agreements. Further enhance your conference experience by attending the master class on Responding to Off-Label Investigations and Enforcement Actions.
Don’t miss this unique opportunity to benchmark your practices against others in the industry. Obtain answers to your most pressing questions and get the information you need from experts in the field. Delegates will also benefit from the extensive written materials prepared especially for this conference.
Tags: Compliance, FDA, Legal conferences, Marketing, Medical Device, Off Label, Pharma
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CHINA SUMMIT ON ANTI-CORRUPTION
July 15th, 2008
in Anti-Corruption / FCPA, Ethics Credits, Regulatory & Compliance |
July 15-16, 2008 | InterContinental Shanghai Pudong | Shanghai, China
Implementing Effective Corporate Governance, Transparency and FCPA Compliance Programs
KEYNOTE SPEAKER:
Mark. F. Mendelsohn
Deputy Chief, Fraud Section,
Criminal Division,
U.S. Department of Justice
(Washington)
Learn how to:
• Implement an anti-corruption compliance program that overcomes
cultural and legal challenges
• Operate joint-ventures with state-owned enterprises (SOEs)
• Identify the kind of gifting or payment that is acceptable and in what instances
• Conduct effective M&A due diligence and internal investigations in China
• Control agents and distributors
• Design training programs appropriate for the Chinese operational environment
• Create a code of conduct that matters in China
• Identify who is a “government official” in China
Foreign companies doing business in the People’s Republic of China
face complex anti-corruption compliance challenges.
Corruption is a serious problem in China’s rapidly developing economy.
China’s leaders have recognized this problem and adopted increasingly
aggressive policies to deal with it. According to Chinese authorities, tens of
thousands of corruption allegations against Chinese officials are investigated
each year, and offenders are prosecuted or otherwise disciplined. China has
also begun vigorously enforcing commercial bribery laws in its private sector.
At the same time, U.S. companies, and companies listed on U.S. stock
exchanges, must comply with the FCPA when doing business in China.
FCPA compliance is especially challenging in China, where government
regulation of the economy remains rigorous and state-owned enterprises
continue to dominate many sectors. These difficulties are reflected in
recent FCPA prosecutions. Several published cases in recent years –
Lucent, Schnitzer Steel, York International, Diagnostic Products – have
focused on activities in China, and many pending investigations
reportedly also involve compliance issues in China.
If your company is doing business in the People’s Republic of China,
you must have a comprehensive anti-corruption compliance program
and be prepared to act promptly and effectively to remedy any problems
that do arise.
This China Summit on Anti-Corruption brings together an exceptional
faculty of experienced corporate ethics and compliance executives, senior
attorneys, forensic accountants and government officials to discuss the
complex anti-bribery landscape in China. They will examine the
intersection of the FCPA and local Chinese anti-bribery laws and how to
implement robust anti-corruption policies in this environment, including:
• Creating a code of conduct that matters in China
• Overcoming cultural and legal challenges in rolling out
an anti-corruption compliance program
• Working with state-owned enterprises (SOEs)
• What kinds of gifts are acceptable and in what instances?
• Due diligence: best practices for third party relationships in China
• Who is a “government official” in China?
• Conducting internal investigations in China
Participants will also receive a comprehensive set of written 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.
Tags: Anti-corruption, Bribery, China, Compliance, Due Diligence, FCPA, Legal conferences, Transparency
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DRUG & DEVICE PREEMPTION
July 14th, 2008
in Healthcare, Litigation, Pharmaceuticals / Biotech / Life Sciences |
Eliminating product liability claims on the wholesale level in an evolving legal landscape. Save millions by effectively using the preemption defense in drug and device cases…
July 14-15, 2008 | The Union League, Philadelphia, PA
Preemption is unquestionably the most powerful defense available
to a drug or device manufacturer in product liability litigation because of its potential to eliminate all failure-to-warn claims involving a particular product. A win on preemption can save a company millions of dollars in litigation fees/discovery costs and potential jury awards. However, the uncertain state of preemption law at this time creates challenges to successfully asserting this defense.
Preemption law is at a crossroads, threatening your ability to utilize the most inexpensive route to victory
The Supreme Court’s silence on the issue of preemption is coming to an end. The trilogy of cases granted certiorari during the 2008 term have the potential to change product liability litigation as we know it, and the industry is anxiously awaiting the Court’s final decision. While the win for device manufacturers in Riegel seemed to indicate that the Court would strongly uphold preemption in all three cases, the split decision in Kent dealt a blow to pro-preemption advocates and has left everyone guessing as to what the court will decide in Levine and what the Third Circuit will hold in the
Colacicco/McNellis companion cases. Plus, a draft anti-preemption bill circulated on Capitol Hill would legislatively reverse Riegel. As the
preemption law landscape changes, drug and device litigators and in-house counsel need to prepare for this pivotal time.
An expert faculty will show you how to manage the changing preemption landscape as you seek dismissal of your cases
In order to successfully assert the preemption defense, litigators and in-house counsel need to know how to take full advantage of recent court rulings favoring preemption. Our faculty of preemption experts will analyze the nuances of recent decisions and provide their insights into how to use these cases effectively in future litigation. In addition, the faculty will examine every possible outcome in the Levine case to prepare you for what is sure to be a landmark decision. Also learn how preemption can be applied in non-failure to warn claims and get speakers’ insights into what novel theories of liability plaintiffs’ counsel may pursue next.
Tags: Legal conferences, Litigation strategies
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