Archive for April, 2009
FCPA and International Anti-Corruption for the Pharmaceutical and Medical Device Industries
April 28th, 2009
in Anti-Corruption / FCPA, Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
Learn how to:
• IMPLEMENT the most effective strategies
for conducting due diligence of third parties
• CREATE a comprehensive compliance and
training program for overseas drug and device
marketing and product development
• DEVELOP practical solutions for routine
interactions with health care professionals
• UNCOVER the best practices for operating
in emerging regions
The government is shining a spotlight on the pharmaceutical and medical device industries.
Now more than ever before, the United States Department of Justice and
Securities & Exchange Commission are investigating and prosecuting alleged
instances of bribery and corruption overseas by pharmaceutical and medical
device manufacturers.
Government insiders predict 2009 and 2010 will be watershed years
for FCPA enforcement actions against pharmaceutical and medical
device companies.
2008 culminated in the largest number of government investigations against
the medical device industry since the FCPA was enacted over 30 years ago.
Insiders estimate there are currently more investigations underway by the SEC
and DOJ combined against medical device manufacturers than any other
industry, and this is just the beginning. The U.S. government has devoted
millions of dollars over the past two years to increase enforcement on the life
sciences sector, perfecting their strategies and collecting evidence.
Bribery as standard operating procedure is over. Pharmaceutical
and medical device companies must exert greater control over
foreign business partners.
Enforcement at home is just the beginning. With increased international
cooperation, investigations are approaching from all sides. It has never been
more important for the life sciences industry to benchmark their compliance
programs and gain greater control over employees, subsidiaries, and third
party business partners overseas.
In response, ACI’s FCPA and International Anti-Corruption for the
Pharmaceutical and Medical Device Industries will provide you with the
comprehensive legal and compliance information essential to formulate and
hone proactive strategies for successfully protecting your company and clients
before, during, and after a government investigation. Our expert faculty
of government, in-house pharmaceutical and medical device counsel, and
preeminent FCPA and white collar crime attorneys will present delegates
with the anti-corruption compliance fundamentals as well as the real-life
strategies used by pharmaceutical and medical device companies who have
faced enforcement. Drawing from their experience, learn the industry-specifi c
solutions to remain complaint by registering today.
3rd Annual Paragraph IV Disputes
April 27th, 2009
in Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
Preeminent patent litigators and in-house counsel will provide insights on the latest legal challenges affecting Paragraph IV litigation for both generic and branded drug makers. Learn from the industry experts and refine your skills on:
• Strategically evaluating patent strength, Orange Book listing and assertion strategies
• Interpreting and applying the MMA statutory scheme as it applies to declaratory judgments
• Litigation with multiple ANDA filers in various jurisdictions
• Implementing effective and cost-saving e-discovery and document management processes during Paragraph IV litigation
• Mastering the interplay between 180-day exclusivity, forfeiture provisions and citizens petitions
• Minimizing downstream risk and calculating damages associated with preliminary injunctions and at risk launches
• Factoring recent local patent rule and proposed patent reform changes into your litigation strategy
With 549 ANDA’s containing Paragraph IV Certifications currently
pending before the Office of Generic Drugs, patent litigators on both
sides, must be acutely attuned to what their opponent’s next move may
be in order to achieve success at trial. Several changes have taken place
in the past few months that will have an impact on Paragraph IV
litigation in 2009. With a new administration taking office, bringing
with it different priorities for patent reform legislation and market
exclusivity for brand name products, this event is the one forum both
brand name and generic litigation counsel can attend to obtain the
latest updates on issues affecting the outcome of Paragraph IV disputes.
Litigating in an environment where a conflicting standard continues
to persist on the issue of reverse payment settlements and a
convoluted MMA structure provides the last say on forfeiture,
Paragraph IV challenges have become more costly and complex in
recent years.
THE event for Hatch-Waxman litigators representing both brand
name and generic companies to gain insights into the most current
issues affecting Paragraph IV litigation, discussing everything from
pre-litigation due diligence strategies to at risk launches – and every
step in between.
Also, to gain in-depth insights into the unique issues presented by
settlement agreements and the antitrust issues they raise, add value to
your attendance by joining us at the Advanced Master Class on
Obtaining Optimal Terms and Mitigating Antitrust Concerns When
Settling Paragraph IV Disputes: Brand Name and Generic Perspectives.
In this high-stakes, high-risk litigation, you cannot afford to make the
wrong move. Learn what strategies you can implore to ensure your
success at trial!
2nd National Forum on OFAC ENFORCEMENT and COMPLIANCE
April 21st, 2009
in International Trade & Defense |
GET THE LATEST INSIGHTS ON:
• Application of OFAC’s Economic Sanctions Enforcement Guidelines and “General Factors”
• Structuring your screening and sanctions compliance program
• Conducting sanctions due diligence for underwritings, international financings, joint-ventures, mergers and acquisitions
• Deciding whether, how and when to make a voluntary self-disclosure under new enforcement guidelines
• Minimizing facilitation risks posed by foreign subsidiaries and third parties
• Responding to potential violations and conducting cost-effective internal investigations
• Working with OFAC to expedite licensing process
Can Your Sanctions Compliance Program Sustain the Heat of Increased International Enforcement?
The Treasury Department’s Office of Foreign Assets Controls (OFAC) is
stepping up enforcement of U.S. economic sanctions.
Companies operating in the global market face significant challenges as stricter
and broader restrictions are imposed to prevent trade or financial transactions with
targeted governments or entities. Risks associated with U.S. embargo programs
are also increasing, as companies are restricted from doing business with third-country
entities and persons acting on behalf of a sanctioned government.
With the dramatic increase in penalties amounts under IEEPA and new OFAC
enforcement guidelines, exporters, banking, insurance, securities and other
financial services firms must ensure preventative measures are in place or risk
severe penalties reaching into the multimillions.
Now in its second iteration, American Conference Institute’s National Forum
on OFAC Compliance and Enforcement has assembled an exceptional faculty
of leading industry executives, attorneys and government offi cials who will
analyze the latest information on:
• How OFAC measures the nature and extent of cooperation
• How to conduct a “look-back” investigation
• What OFAC guidelines reveal about the essential components of an effective sanctions compliance program
• How global companies can overcome challenges of unilateral sanctions
• Facilitation risks when working with non-US third parties
• Dealing with U.S. sanctions against Iran
• What OFAC wants to see in a license application
Tags: Legal conferences, OFAC
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9th forum on FRAUD & ABUSE IN THE SALE AND MARKETING OF DRUGS
April 20th, 2009
in Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
RE-SHAPING COMPLIANCE PROGRAMS TO MEET NEW CONDUCT STANDARDS
AND SHIFTING ENFORCEMENT PRIORITIES
Featuring Frontline Insights from Industry Leaders:
Adolor • Astellas • Daiichi Sankyo • Eisai • Eli Lilly • Gilead • King • Mylan
• Pfizer • sanofi-aventis • Sepracor • Talecris • Taro • Wyeth …And Many More
THE event for your legal, compliance, and sales & marketing teams.
Leading in-house counsel, top prosecutors, and expert attorneys in the
field will help you to:
• UPDATE compliance programs to reflect the new PhRMA Code
• COMPLY with new state reporting requirements and increased state enforcement
• ANALYZE what conduct can lead to off-label charges
• ENSURE that CME activities do not lead to kickback allegations
• ADJUST policies in light of the proposed federal Sunshine Act and
other legislative initiatives
• INTEGRATE international considerations into compliance strategies
• CONTROL activities in the field by sales reps
• PREPARE for and deter possible allegations by whistleblowers
More than $1 Billion Recovered by Justice Department in 2008…Congressional Inquiries…
Increased Enforcement and Legislation at the State Level…Revised PhRMA Code of Conduct
Never before have pharmaceutical companies been so pressured by issues arising simultaneously on the state, national and international level. At this uniquely trying time, day-to-day activities can become the focus of inquiries by members of Congress, investigations by federal and/or state prosecutors, and whistleblower claims. In addition, companies must keep track of legislative initiatives seeking broader industry disclosures and comply with new reporting requirements. Also, PhRMA, the industry’s own association, has just released a new code of conduct in an effort to address these concerns, and MedPac has adopted new recommendations relating to financial relationships with physicians.
Companies must now focus on revising internal practices to meet the new standards that have been set. They must take extra precaution to ensure that they are minimizing the risk of being accused of engaging in activities that constitute off label promotion or
violate the False Claims Act or the FCPA. American Conference Institute has specifically designed its 9th National Forum on Fraud and Abuse in the Sale and Marketing of Drugs to be an intensive and comprehensive guide for staying one step ahead of the latest legal
exposures, liabilities, and risks that are of the greatest concern to the pharmaceutical industry. Special attention will be paid to the implications of the new PhRMA code and how companies need to respond to it.
The expert faculty includes in-house professionals from Adolor, Astellas, Daiichi Sankyo, Eisai, Eli Lilly, Gilead, King, Mylan, Pfizer, sanofi-aventis, Sepracor, Talecris, Taro and Wyeth. In addition, this conference features federal and state enforcement sessions with
leading government prosecutors.
Plus, our interactive and in-depth Master Class, Conducting Effective Internal Investigations, will provide you with practical methods for ensuring that everyone in your sales and marketing divisions are compliant. You will learn the necessary techniques, strategies, and tactics that will invaluably enhance your investigatory efforts.
