Archive for March, 2009
Distressed Debt & Turnaround Investing Summit
March 31st, 2009
in Financial Services |
Achieve your competitive advantage and formulate your successful Investing strategy by:
- Assessing the current market conditions to make educated predictions
for the next fiscal year
- Scanning industries for potential investment opportunities and pinpointing
the warning signs of businesses approaching insolvency
- Identifying methods to valuate distressed companies to ensure maximum returns
- Developing techniques to estimate the recovery possibilities for distressed debt
- Grasping bankruptcy laws and insolvency regimes in place in foreign markets
to facilitate wise investment decisions
- Understanding the necessary financial and operational restructuring tools
to maximize your ROI and make the most of your investment
- Implementing effective cross-border restructurings by fully comprehending
the complexity of these transactions
In light of the current state of the economy, this could not be a timelier event.
With the credit crunch and the liquidity crisis pushing more and
more companies toward insolvency, the market for distressed debt
and restructurings is busier than everwith increased opportunity for
investment. However, the increased quantity of distressed prospects
does not equate to guaranteed returns on your investments.
Investing in distressed debt and turnaround is an extremely
complicated process in which invesments should be chosen and
timed carefully. You need to be aware of the factors involved in order
to execute a successful investment strategy and navigate in this volatile
market. This summit will take you through the steps necessary to
maximize your ROI and make the right investment decisions.
Key themes explored at this year’s summit:
• An in depth market forecast for 2009- predicting market
conditions for the coming fiscal year
• Strategies to maximize your investment returns
• Methods for valuation of the company in distress and the
tools necessary for successful turnaround
• The regulations and processes unique to investing
in foreign markets
This event is a must for anyone involved in the distressed debt
market- investors, financial advisors, brokers, lenders, lawyers and
consultants. Don’t miss your chance to hear from industry leaders
and formulate your investment strategy in this uncertain market.
With expert advice and best practices, you cannot afford to miss
this event.
FDA BOOT CAMP. Basic Training for Products Liability and Patent Lawyers
March 30th, 2009
in Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
A Who’s Who of the nation’s Food and Drug bar will drill you in the basics of
FDA law and regulation — and the nuances of the 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 CDER, CBER,
and CDRH
• GAIN a practical working knowledge of the essential clinical trials processes
for drugs and biologics, and the clearance process for devices
• UNDERSTAND how devices are classified, monitored, and regulated
• EXPLORE the pivotal role of labeling in the drug and biologics approval process
• APPRECIATE the complexities of pharmaceutical IP and the regulatory balance
between brand name and generic products
• UNCOVER the importance of cGMPs to the post-approval regulatory process
• LEARN to navigate the protocols of adverse events monitoring, signal detection,
product withdrawals, and recalls
• DISCOVER the changing legal landscape of the defense of preemption
• ANALYZE the future of follow-on biologics
Discover how to navigate the regulatory maze that is crucial to your cases and
practice areas so you can:
• Be the best life sciences Products Litigator or Patent Attorney you can be
• Develop greater securities and investment expertise in your field
The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. And with the ever-evolving regulations and ground breaking patent legislation and preemption case law concerning FDA-regulated products on the horizon, it is essential for attorneys who do not have regulatory practices – but who deal with FDA-regulated products – to understand the rules and regulations that impact your business. The
same demands fall on securities experts and business executives in the life sciences arena. Additionally, the election of the Obama Administration and a new Congress, as well as the continuing efforts to conform with and understand the regulatory changes made by the introduction of the FDAAA make comprehending and gaining a solid foundation in the regulatory framework of FDA law more important than ever.
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.
Boot your FDA regulatory IQ.
Learn about the FDA approval process and the ins and outs of post-approval challenges.
ACI’s FDA Boot Camp, the industry standard in providing non-regulatory professionals with a regulatory background, 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 regulatory competencies, including the nuances of the 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:
- NDAs
- 505b2s
- INDs
- 510 K submissions
- BLAs
- PMA process
- ANDA applications
• Clinical trials for drugs and biologics and the clearance process for devices
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Act in the patenting of drugs and biologics
• Labeling in the drug and biological products approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring
• Recalls, product withdrawals, and FDA oversight authority
Other program highlights include special tracks for Patent Attorneys and Products Litigators including two Post-Conference Workshops.
FDA Boot camp: Basic Training for Products Liability and Patent Lawyers
March 30th, 2009
in Intellectual Property, Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. And with the ever-evolving regulations
and ground breaking patent legislation and preemption case law concerning FDA-regulated products on the horizon, it is essential for attorneys who do not have regulatory practices – but who deal with FDA-regulated products – to understand the rules and regulations that impact your business. The
same demands fall on securities experts and business executives in the life sciences arena. Additionally, the election of the Obama Administration and a new Congress, as well as the continuing efforts to conform with and understand the regulatory changes made by the introduction of the FDAAA make comprehending and gaining a solid foundation in the regulatory framework of FDA law more important than ever.
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! Learn about the FDA approval process and the ins and outs of post-approval challenges.
ACI’s FDA Boot Camp, the industry standard in providing non-regulatory professionals with a regulatory background, 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 regulatory competencies, including the nuances of the 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 processes for drugs, biologics, and devices, including: NDAs, 505b2s, INDs, 510 K submissions, BLAs, PMA process, ANDA applications.
• Clinical trials for drugs and biologics and the clearance process for devices
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Act in the patenting of drugs and biologics
• Labeling in the drug and biological products approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring
• Recalls, product withdrawals, and FDA oversight authority
Tags: Biologics, FDA, Legal conferences, Medical Devices, Patent, Regulation
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4th Cross-Industry Forum on GLOBAL TRANSFER PRICING
March 25th, 2009
in International Trade & Defense |
A unique region-by-region and country-by-country focus on adapting to increased
audit activity and the ever changing regulatory framework of transfer pricing
get the latest information and strategies from leading attorneys,
accountants, economists, and industry tax executives, including how to:
-ENSURE compliance with new and evolving U.S. Service Regulations
and cost-sharing regulations
-EXAMINE the impact of OECD draft discussions regarding comparability,
profit methods, business restructuring and permanent establishment
on your company’s transfer pricing policy
-ACHIEVE consistency in inter-company documentation requirements
-DEMYSTIFY the audit process through proper preparation and negotiation
-UTILIZE Advance Pricing Agreements (APAs) as a risk management tool
-ADAPT to regional variations in transfer pricing rules and regulation
and STAY up to date on changes in transfer pricing rules all over the world
-HARMONIZE transfer pricing policies in cross-border transactions
and inter-company service arrangements
-REDUCE potential penalties imposed by foreign taxing authorities
in today’s rigorous enforcement landscape
You know the news:
-The Senate Finance Committee recently commented on
their plan to “tackle tax reform in 2009” due to the increase in
multinationals shifting taxable income outside of the U.S.
-The global transfer pricing world remains in flux as a
result of the OECD’s recent release of the draft discussion on
business restructuring, China’s implementation of transfer
pricing regulations, and the new U.S. Service Regulations
-The U.S. and other foreign taxing authorities around the globe
are vigorously targeting multinational companies through audits
There has never been a more important time to attend
ACI’s one-of-a-kind Global Transfer Pricing forum
From the Senate Finance Committee threatening “full-fledged”
tax reform in 2009 to the increase and complexity in audits
by foreign taxing authorities, multinational companies are
faced with the challenge of trying to keep up to date on
changes in transfer pricing rules globally. All of this has led to
an increase in cross-border tax disputes. Countries that
previously did not enforce transfer pricing regulations are now
emerging as major players in the transfer pricing world, and as a
result in-house tax professionals and transfer pricing
specialists at multi-national companies have little to no room for error.
In order for your company to avoid substantial penalties and
stay competitive, you need an intensive, up-to-the-minute
review of the most pressing issues that arise in global
transfer pricing.
The answer is ACI’s 4th Annual Cross-Industry Forum on
Global Transfer Pricing, a must-attend event for all
international tax and transfer pricing specialists. Through a
distinguished faculty of top tax and legal experts, including
in-house transfer pricing specialists from Caterpillar, Citigroup,
Gucci, Intel, Rolls Royce, Siemens, and UPS, this two-day
conference will provide even the most seasoned transfer
pricing specialists with current information and clarity on
overcoming today’s most complex transfer pricing challenges
on a region-by-region and country-by-country basis.
PLUS, add value to your attendance by also registering
for the Post-Conference Master Class:
Establishing, Implementing and Maintaining an Effective
Global Transfer Pricing System Within Your Company
(March 26, 2009 – 2:30 p.m.-5:30 p.m.)
5th Advanced Global Customs Compliance Event Brazil, India & China Customs Compliance
March 24th, 2009
in International Trade & Defense |
Learn what it takes to prevent border
delays, minimize importation costs and
optimize supply chain structures in the
world’s leading markets
U.S. companies importing into Brazil, India and China face unique and
complex tax and customs challenges and must learn how to navigate each
local regulatory environment to maintain compliant customs operations.
U.S. companies importing into Brazil, India and China face unique and
complex tax and customs challenges and must learn how to navigate each
local regulatory environment to maintain compliant customs operations.
Now in its 5th successful year, ACI’s Advanced Forum on Global Customs Compliance presents a revamped conference agenda that focuses on the customs insights you need to succeed in Brazil, India and China. Hear corporate perspectives on how to comply with Brazilian, Indian and Chinese Customs requirements and learn how industry leaders are developing tailored approaches to improve import operations in each country. Benefit from the expertise of senior attorneys from India, Brazil and China and ask your most pressing customs questions.
Highlights from the program will include:
• How to expedite the RADAR registration process in Brazil
• Assessing and minimizing import taxes into Brazil
• Addressing customs issues with Indian government officials and the DRI
• Coping with hurdles to efficient logistics and expediting customs
clearance in India
• Applying China’s country of origin and marking standards
• Overcoming challenges of building relationships with Chinese officials
• Optimizing customs bonded operations in China
ACI 5th Life Sciences Forum on e-Discovery, Document Management and Litigation Readiness
March 24th, 2009
in Litigation, Pharmaceuticals / Biotech / Life Sciences |
Advanced Strategies for Minimizing Costs, Streamlining
Document Production and Managing e-Discovery During Litigation
Attend this one-day, advanced-level forum where
in-house and outside counsel experienced in tackling
e-discovery and litigation management issues will offer
you the most up-to-date and efficient strategies for:
✓ Implementing an effective litigation hold on ESI – and auditing compliance
✓ Gathering and monitoring e-data stored on multiple databases in decentralized locations
✓ Reviewing and producing proprietary and highly sensitive product and company information during discovery
✓ Cost-effectively managing outside counsel and vendor relationships during litigation
✓ Responding to extensive production requests during government investigation
Since the e-Discovery amendments to the Federal Rules of Civil Procedure were made effective two years ago, it is has since become clear that companies within the life sciences industry are still trying to find their way in the maze of electronic information management. Additionally, now that FRE 502 has been codified, even more questions exist as to how federal courts will evaluate inadvertent disclosures, what the triggering events are for subject matter waiver and what rules will be applied in state courts on this issue.
The need for cost-effective and efficient best practices has
never been greater, as pharmaceutical, biotechnology and
medical device companies continue to defend against
increasingly complex and high stakes litigation on all fronts,
stemming from intellectual property disputes, government
investigations and product liability claims. With companies
competing to maintain market share in a volatile economy, it
is imperative to your success at trial, that your document and
information management protocol are both efficient and reliable
in order to effectively defend against litigation.
Re-structured to provide you with focused, advanced-level
discussions on proven and practical solutions for re-visiting your
litigation plan, ACI is pleased to offer you the Life Sciences Forum on
e-Discovery, Document Management and Litigation Readiness.
Benchmark your current practices and procedures against
those of your colleagues, as our experienced faculty guides you
through an intense, one-day exploration of the most troublesome
aspects of developing a document management protocol and
responding to e-discovery during litigation.
Also, for a more base-level discussion on issues associated with
record retention and compliance, the pre-conference boot camp
drilldown, Life Science’s Industry Guide to Record Retention
and Compliance, will walk you through all of the necessary steps
for implementing an airtight records retention policy, while also
providing you with strategies for auditing compliance.
Tags: Legal conferences, Litigation strategies
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21ST NATIONAL CONFERENCE FOREIGN CORRUPT PRACTICES ACT
March 24th, 2009
in Anti-Corruption / FCPA |
THE PREMIER LEGAL & REGULATORY ANTI-CORRUPTION COMPLIANCE EVENT
Get “must-have” insights from senior industry executives, FCPA attorneys
and government officials on:
• Minimizing risk when working with state-owned entities
• Preparing for heightened scrutiny of facilitating payments
• Conducting cost effective internal investigations while maximizing credibility
to the government
• Implementing robust fraud risk internal controls
• Voluntary disclosures: criteria to determine when to disclose, or not
• Responding to a multi-jurisdictional government investigation
• Collateral litigation for foreign corrupt practices: latest RICO, shareholder
and contract cases
• Conducting effective third party due diligence
Do not miss the FCPA event that everyone is talking about
21ST NATIONAL CONFERENCE
FOREIGN CORRUPT PRACTICES ACT
Vigorous enforcement of the Foreign Corrupt Practices Act
continues to be a priority for the US Department of Justice and
the US Securities and Exchange Commission, across industries
and around the globe.
The past 12 months produced the largest number of FCPA
cases, the largest criminal fine to date and the largest combined
sanction ever imposed for violations of the FCPA. Recent
settlements have resulted in heavy civil and criminal penalties
for both individuals and corporate offenders, disgorgement of
profits and, increasingly, the imposition of independent
monitors. Foreign governments, primarily in Europe, are also
cracking down on corruption and actively cooperating with US
enforcement officials.
The increase of FCPA enforcement makes prevention an even
higher priority than it may have been in the past. The absence
of preventative measure is almost certain to result in
substantially increased penalties if an issue arises. This makes an
effective anti-corruption compliance program essential for all
companies. With record-setting sanctions involving well-known
companies, global organizations have to reassess their own anticorruption
measures to prevent lapses that might lead to
damaging and costly enforcement actions.
Now in its 21st successful year, the American Conference Institute‘s National Conference on the FOREIGN CORRUPT PRACTICES ACT is the event that corporate counsel, compliance officers, outside counsel and consultants rely on for comprehensive, insightful, and practical guidance on critical FCPA compliance issues. Benefit from the practical
perspective of seasoned corporate FCPA compliance executives, get an update on enforcement and policy initiatives from top Government officials and FCPA attorneys, 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:
• Changes you need to make to your compliance program
as a result of recent cases against companies and individuals
• How government agencies evaluate voluntary disclosures
• The FCPA’s definition of facilitating payments:
when grease becomes a bribe
• Deciding whether you’ve investigated “enough”:
how much is enough in trying to learn the facts?
• Risks and concerns when a joint-venture partner
is a governmental entity
• What your system of fraud risk internal controls needs
to accomplish
• Communicating with government authorities: balancing
cooperation with maintaining an effective defense
Prescription Drug Pricing
March 11th, 2009
in Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
7th Annual Advanced Forum on Government Regulation of Prescription Drug Pricing
The premier legal and regulatory pricing and reimbursement event that will help you see the whole pricing and reimbursement picture by learning the latest on…
• The NACDS/NCPA litigation challenging the final AMP rule
• Changes to government and commercial pricing practices resulting from AWP litigation
• Preventing negative pricing situations where the URA is higher than the actual acquisition cost
• TRICARE rebates
• Legislative priorities of the new administration and their effect on pricing
• Antitrust concerns associated with exclusive dealing, tying and bundling
• Developing and maintaining effective pricing compliance controls
Experts predict that 2009 will bring substantial changes to drug pricing
for government payor programs
Prepare for those changes and learn how to maximize reimbursement
when working with government programs
Since the enactment of the Medicare Modernization Act, manufacturers, PBMs, pharmacies and plans have had to manage the continuous evolution of drug pricing for government payor programs. Each year brings new challenges and more changes to contend with, and 2009 is shaping up to be no different. Not only is it costly to repeatedly modify internal pricing practices to comply with new rules and regulations, but constant changes leave pricing stakeholders in a state of uncertainty making it difficult to develop a comprehensive pricing strategy.
ACI’s 7th Annual Advanced Forum on Government Regulation of Prescription Drug Pricing is the one conference that will prepare you for the changes ahead. By delving into the regulatory, legislative, and legal aspects of drug pricing, this annual event allows you to see the complete pricing and reimbursement picture. Not only will you obtain the latest information on pending litigation and legislative proposals, you will learn how they will impact your pricing functions and how to adjust your pricing strategy accordingly.
As always, our faculty of experts will provide in-depth analysis of critical issues affecting the pricing sector. Learn how:• The NACDS/NCPA litigation will impact the July 2007 AMP rule
• State Medicaid programs plan to use AMP
• TRICARE rebates will affect non-FAMP calculations
• AWP litigation amongst the states is evolving and what new theories of liability and damages are being asserted
• Bundled discounts should be allocated
• Changes to the AMP rule are creating situations where URA exceeds actual acquisition cost and how to prevent statutory discounts from turning into a profi t center for the government
• Government enforcers choose which pricing cases to pursue
• SNHPA litigation involving collection of NDC numbers could affect reimbursement exposure
Russia and CIS Summit on ANTI-CORRUPTION
March 11th, 2009
in Anti-Corruption / FCPA |
Minimize the Risk of Improper Payments in an
Era of Increased International Enforcement
Foreign companies doing business or investing in the Russian
Federation and CIS countries face complex and unique anticorruption
compliance challenges. Problems of corruption in Russia
and the CIS for foreign investors have increased dramatically in the last
several years. Allegations of bribes required by government officials
directly and through intermediary companies are rampant.
Local leaders have recognized this problem and on July 31st, 2008,
Russian President Dmitry Medvedev signed the National Anti-Corruption
Plan. A new Federal Law against corruption is expected very soon. At
the same time, U.S. companies, and foreign companies listed on U.S.
stock exchanges, must comply with the FCPA when doing business in the
region. FCPA compliance is especially challenging in Russia and the CIS
and many pending investigations reportedly involve compliance issues in
the region.
If your company is doing business in Russia or the CIS, you must put a
comprehensive anti-corruption compliance program in place and be prepared
to act promptly and effectively to remedy any problems that do arise.
This one-of-a-kind Summit on Anti-Corruption brings together an
exceptional faculty of seasoned corporate ethics and compliance
executives, senior attorneys, forensic accountants and government
officials. They will provide a comprehensive update on the anti-bribery landscape in Russia and the CIS, the intersection of the FCPA and local
anti-bribery laws and how to implement robust anti-corruption policies to
comply with local laws and the FCPA, including:
• Who is a “government official”?
• What kind of gifting or payment is acceptable and in what instances?
• How to create a culture of ethics
• Due diligence: best practices for a prospective third party relationship
• Creating a Code of Conduct that matters in Russia and the CIS
• Conducting internal investigations
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.
