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Expert Article by Amy Ross Lauck
According to the Treasury Inspector General for Tax Administration (TITGA), the number of tax-related ID theft incidents has grown significantly since 2008, and the problem appears to be getting worse. The IRS reported that the number of tax-related ID theft incidents in the calendar year 2011 alone was nearly three times the number of incidents reported in 2009 and 2010. 
The IRS indicated it was able to self-identify and prevent issuance of approximately $6.5 billion in fraudulent tax refunds during the 2011 calendar year. Despite these efforts, an analysis conducted by TITGA found that the number of fraudulent tax returns that were actually filed and processed by the IRS during the 2011 calendar year was significantly larger than what the IRS was able to detect and prevent.
According to TITGA, a significant majority of taxpayers (approximately 72 percent of taxpayers in 2011) are requesting to have their tax refunds direct deposited to their checking or savings account, or to a prepaid card. Unfortunately, direct deposit also has become the preferred method used by fraudsters to obtain fraudulent tax refunds. This type of disbursement method allows fraudsters to simply spend down the funds or withdraw funds from an ATM without having to provide identification, as would normally be required when cashing a paper refund check. ID theft is typically a prerequisite to tax refund fraud because federal income tax returns are tracked using individual taxpayer names and taxpayer identification numbers (TINs). Fraudsters have used various methods to obtain taxpayer information, including establishing fraudulent tax preparation businesses, phishing schemes and collusion with tax preparers or IRS employees.
Financial institutions and service providers, including prepaid access providers, play a significant role in helping the Treasury Department and law enforcement identify and prevent tax refund fraud because tax refund fraud, particularly via direct deposit, is commonly carried out by depositing refund proceeds to one or more accounts established through a financial services provider or multiple financial services providers. Although the prepaid industry has been diligently assisting the Treasury Department and law enforcement in mitigating tax refund fraud, the continued perception by certain media outlets and members of Congress that the industry is perhaps not doing enough or is potentially even enabling the fraud is disappointing to say the least. The prepaid industry, the Treasury Department and law enforcement share a common goal in wanting to identify and prevent tax refund fraud. Steps must be taken by all parties involved to assist in this effort. (See sidebars at xxx.)
The IRS has indicated it will employ a number of initiatives for the 2013 tax filing season to help detect tax-related ID theft before fraudulent tax refunds are processed. These initiatives include:
• Designing new ID theft screening filters, including filters to identify changes in taxpayer circumstances from year to year.
• Expanding its efforts to assist victims of ID theft by assigning victims identity protection personal identification numbers (PINs) and placing ID theft indicators on victims’ accounts for additional screening.
• Expanding its efforts to prevent payment of fraudulent tax refunds claimed using deceased individuals’ names and TINs.
• Analyzing data from prior ID theft cases to identify commonalities and trends that could be used to detect and prevent future tax refund fraud.
• Attempting to use (1) current income and withholding information for individuals who receive Social Security benefits and (2) prior third-party income and withholding information to validate current-year income documents submitted in connection with questionable tax returns.
• Establishing a specific code that financial institutions may use to reject questionable direct deposits specifically for name mismatches or questionable tax refunds.
• Developing new filters to identify multiple deposits to the same account and instances where it appears tax return preparers and IRS employees may be improperly using the direct deposit program for unintended purposes.
• Developing messaging to remind taxpayers and tax return preparers that taxpayers should not be direct depositing any portion of their refund to an account they do not own.
TITGA has identified a number of other recommendations to assist the IRS in combating tax refund fraud. These recommendations include:
• Employing a real-time tax system to allow the IRS to verify current third-party income and withholding information to identify potentially fraudulent returns with false income documents. This recommendation would necessitate legislation to provide the IRS the ability to access and use current income information available through the National Directory of New Hires (“NDNH”) database.
• Limiting the number of tax refunds that can be deposited to the same tax account and coordinating with other Federal agencies and financial institutions to develop a process to ensure that tax refunds issued via direct deposit to either a bank account or prepaid account are made only to an account held in the taxpayer’s name.
• Working with the Department of Treasury Financial Crimes Enforcement Network (“FinCEN”) to develop procedures that can be implemented to ensure authentication of individuals’ identities and prevent the direct deposit of tax refunds to debit cards issued or administered by financial institutions that do not take reasonable steps to authenticate individuals’ identities.
• Adopting common industry practices for authenticating taxpayers’ identities, not only in the processing of tax returns but also when taxpayers call or write to the IRS requesting assistance with their refund (e.g., asking out of wallet questions or other ID verification information).
• When the IRS processes a tax return with an address different from the one it has on file, notifying the taxpayer that his or her account has been changed with the new address and suspending correspondence at the new address until the taxpayer has validated the address change.
The IRS is evaluating the feasibility of implementing these recommendations, but has previously indicated that budget cuts and staffing reductions have impaired its ability to combat all the potentially fraudulent tax refunds it identifies. Nevertheless, the initiatives the IRS has recently employed will, hopefully, help curb the incidence of tax refund fraud going forward.
WHAT PREPAID PROVIDERS CAN DO
Like the IRS and law enforcement, prepaid access providers have also been seeking ways to more effectively combat tax refund fraud. If you offer a prepaid program that allows accountholders to load tax refunds to their prepaid accounts, there are three key ways you can assist in identifying and preventing tax-related ID theft and fraud in connection with your prepaid program:
1. Know Your Customer
Properly authenticating an applicant’s identity is a critical step in mitigating the risk of ID theft and preventing tax refund fraud. If your prepaid program allows accountholders to load federal tax refunds to their prepaid accounts, you should ensure that you have a written customer identification program (CIP) including reasonable procedures to allow you to verify the identity of each applicant, particularly before cash access is enabled on the account.
2. Monitor Your Accounts
Account monitoring, both at the time of account opening and on an ongoing basis, is also an essential step in identifying and preventing tax refund fraud. Effective monitoring includes establishing account parameters (e.g., individual and aggregate velocity or dollar limits for associated accounts) and triggers to assist in identifying any red flags or suspicious activity that may suggest an account is being used to facilitate tax-related ID theft and fraud. FinCEN has, in consultation with the IRS and law enforcement, identified several red flags to assist financial institutions in identifying potential tax-related ID theft and fraud. For prepaid accounts, these red flags include:
• Multiple direct deposit tax refund payments, directed to different individuals, from the Treasury Department or state or local revenue offices made to a prepaid account held in the name of a single accountholder.
• Suspicious account openings requested on behalf of individuals who are not present, with the fraudulent actor being named as having signatory authority, particularly if the subsequent source of funds is limited to the direct deposit of tax refund proceeds (typically indicates exploitation of tax returns for the elderly, minors, imprisoned, disabled or recently deceased).
• Opening multiple prepaid accounts by one individual in different names using valid TINs for each of the supplied names but the same mailing address, particularly if tax refund proceeds are direct deposited to these accounts shortly after account activation or in situations where the deposit is followed quickly by ATM cash withdrawals and/or point-of-sale purchases.
• Multiple prepaid accounts that are associated with 1) the same physical address (fraudulent actors may also contact customer service requesting to change their address for their personalized card shortly after opening a temporary card on-line]; 2) the same telephone number or mobile device; 3) the same e-mail address; or 4) the same Internet Protocol (IP) address, which receive tax refund proceeds as the primary or sole source of funds.
In addition to the FinCEN red flags, prepaid providers also may want to consider monitoring for the following:
• Accountholders attempting to load third-party tax refund checks via remote image/deposit capture.
• Inconsistencies in data supplied during application (e.g., providing a Texas phone number but Michigan address).
• Tax refunds direct deposited to accounts with recently added secondary cardholders.
• Multiple cards directed to the same physical location or general geographic vicinity (e.g., same street address but different apartment numbers).
• Seemingly unrelated accounts linked by suspicious and usual email formats (e.g., firstname.lastname@example.org; email@example.com, etc.) or other similar data elements (e.g., similar refund amounts).
• Timing of tax refund, particularly if the refund is received outside the traditional tax season (typically January 15 through April 15).
3. Follow Up on Suspicious Transactions.
To the extent your account monitoring program identifies red flags that might suggest tax refund fraud, you also will want to have procedures in place to ensure that you are timely and appropriately responding to any suspicious activity identified. These procedures might include:
• Attempting to contact the accountholder to confirm account opening and discuss any suspected fraudulent activity. This step may require you to look to third-party resources for contact information as the contact information provided during the application process likely will be unreliable.
• Blocking or returning direct deposits or other transactions that exceed your account parameters or appear to be fraudulent.
• Finally, if you know, suspect or have reason to suspect that a transaction involves funds derived from illegal activity or an attempt to disguise funds derived from illegal activity, you may be required to file a suspicious activity report (SAR) with FinCEN. When completing SARs on suspected tax refund fraud, FinCEN has advised reporting institutions to use the term “tax refund fraud” in the narrative section of the SAR and provide a detailed description of the activity.
While law enforcement has had recent success in uncovering some significant tax-related ID theft schemes and bringing the perpetrators to justice, more needs to be done on the front end to identify and prevent tax-related ID theft and fraud before the fraudsters abscond with taxpayer funds. Successfully combating this issue will require involvement by and cooperation and communication between all interested parties impacted by this issue, including the Treasury Department, law enforcement and financial services providers. Hopefully, the combined efforts these parties have been employing, including the efforts being employed by prepaid providers, will help put the industry on the right path towards reducing the incidence of tax-related ID theft and fraud during the 2013 tax filing season and beyond.
 “Identity Theft and Tax Fraud,” Hearing before the U.S. House of Representatives Committee on Oversight and Government Reform Subcommittee on Government Organization, Efficiency and Financial Management (November 4, 2011) (testimony of J. Russell George, Treasury Inspector General for Tax Administration).
“There Are Billons of Dollars in Undetected Tax Refund Fraud Resulting from Identity Theft”, Final Audit Report by Treasury Inspector General for Tax Administration, Reference Number 2012-42-080 (July 19, 2012). See also, “Processes for the Direct Deposit of Tax Refunds Need Improvement to Increase Accuracy and Minimize Fraud,” Final Audit Report by Treasury Inspector General for Tax Administration, Reference Number 2012-40-118 (September 25, 2012).
 31 C.F.R. § 210.5 requires tax refunds delivered via ACH deposit to be deposited into an account in the name of the taxpayer. If protocols were in place to mandate this, any tax refund deposit not meeting this requirement would be converted to a paper check and sent to the taxpayer. To cash the refund check, the check recipient would likely need to provide a picture ID matching the name on the check. TITGA believes this would serve as a deterrent to individuals seeking to commit tax refund fraud. To date, the IRS has expressed concern about this type of limitation due to situations in which an account is legitimately held in the name of multiple individuals. Furthermore, many financial institutions currently do not have the automated capability to match the name associated with an ACH deposit to the name listed on the account. The IRS has indicated it will take this recommendation into consideration to determine whether such restrictions can be effectively implemented.
 “Identity Theft and Tax Fraud,” Joint Hearing before the U.S. House of Representatives Committee on Ways and Means Subcommittees on Oversight and Social Security (May 8, 2012) (testimony of J. Russell George, Treasury Inspector General for Tax Administration).
 “Tax Refund Fraud and Related Identity Theft”, FinCEN Advisory FIN-2012-A005 (March 30, 2012).
Essential Legal and Practical Strategies for Structuring Products, Mitigating Risk, and Ensuring Compliance
When: Tuesday, January 29 to Wednesday, January 30, 2013
Where: Washington Hilton, Washington, DC, USA
For more information, and to register: click here
NBPCA Annual Congress – The Power of Prepaid
In 2012, NBPCA (the Network Branded Prepaid Card Association) launched Power of Prepaid, an exciting new event that is not only rich in content that is directly relevant to those driving and seeking to grow the Prepaid industry, but which attracted the support and participation of the who’s who of Prepaid industry players, key lawmakers, consumer groups, customers and relevant 3rd parties.
Feedback from attendees was that the mixture of senior leadership of Prepaid companies, government officials and agencies with the most impact on Prepaid and payments – was a power combination and unique to this event.
But don’t take our word for it. Hear for yourself from those who were in attendance.
Unparalleled networking with key DAS and small cell stakeholders and customers; in-depth technical presentations on indoor and outdoor network design and architecture; industry discussion on current business models; and DAS deployment case studies
When: Monday, April 29 to Wednesday, May 1, 2013
Where: PH Resort & Casino, Las Vegas, NV, USA
For more information, and to register: click here
ACI’s DAS Congress Evolves to Encompass Small Cell Coverage Strategies
The premier event for Distributed Antenna Systems expands its focus to address the increasing interest in small cell solutions.
New York, NY, November 19, 2012 — ACI has commenced planning for the 6th annual DAS Congress, which has undergone a name change to the DAS & Small Cells Congress to explicitly address the burgeoning interest in DAS and small cell solutions.
For the past 5 years the event has achieved impressive growth, with 2012 being the largest event to date with 300+ attendees and more than twenty companies sponsoring and exhibiting at the event. With the expansion of the industry and the participants of the conference and exhibit, we can assure you that it will remain the preeminent forum for the latest information for in-building/outdoor and small cells solutions, along with an unrivaled speaker faculty, and unparalleled networking opportunities.
For more information about DAS & Small Cells Congress please visit – http://www.DASCongress.com.
About American Conference Institute
A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.
Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.
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Das & Small Cells Congress Attendee Video
Here’s why 300+ key influencers and decision-makers of the industry attend the DAS and Small Cells Congress
Make certain your company takes the necessary steps to ensure that anti-corruption compliance is an important corporate priority and that it is taken seriously at all levels of your organization
When: Tuesday, January 22 to Wednesday, January 23, 2013
Where: The Carlton Hotel, New York, NY, USA
For more information, and to register: click here
One topic that was presented at last year’s event
Session 1: January 25, 2012
How to Build and Implement an Effective FCPA Compliance Assessment Program
- Brady K. Long, VP, General Counsel & Secretary at Ensco
- Bobby D. Butler, Jr., VP & Chief Compliance Officer at Universal Weather & Aviation
- Karen M. O’Toole, VP & Associate General Counsel at Fidelity Investments
Essential Legal, Regulatory, Technical, and Operational Strategies for Ensuring Compliance and Competitiveness in a Global Market
When: Tuesday, November 27 to Wednesday, November 28, 2012
Where: The Carlton Hotel, New York City, NY, USA
For more information, and to register: click here
Industry related article from Trefis.com, by the Trefis team, posted on 09/25/12:
BNY Mellon Expands Cross-Border Payment Offering, Named Custodian For Chinese Fund
BNY Mellon recently announced the expansion of its cross-border payment offering to accommodate payments in three other currencies besides the U.S. Dollar. The world’s largest custodian bank now allows its clients to make payments in euro (EUR), pound sterling (GBP) and Australian dollar (AUD) too, greatly increasing the scope of its fully automated Payment Decision Service. While this service addition will no doubt increase BNY Mellon’s hold on the global payments market, the bank also gained entry into China this week when it was named the global custodian for a new qualified domestic institutional investor (QDII) fund in the country.
We maintain a price estimate of $27 for BNY Mellon’s stock, which is around 15% above the current market price. We largely attribute this premium to the weak short-term outlook for global custody banking compounded by the deteriorating economic conditions in the Eurozone. The bank’s foreign-exchange related lawsuits are also a bitter pill for investors to swallow.
More Choice for Clients = More Business for BNY Mellon
BNY Mellon’s Payment Decision Service automatically executes cross-border payments on behalf of clients based on various standing instructions which are pre-agreed upon by the bank and its clients. This allows the clients to complete payments across the globe in an efficient and reliable manner. Until recently, however, BNY Mellon’s service was restricted to payments in the U.S. Dollar. Hence, clients who needed to make payments to their vendors/business associates in other currencies were forced to either shoulder additional foreign exchange costs, or go through other payment service providers.
With BNY Mellon enabling payments in three more currencies – EUR, GBP and AUD – the bank essentially supports payments in currencies that account for more than four-fifths of all global payments.
It must be mentioned here that BNY Mellon has been working hard to make good the loss in reputation it suffered, and continues to suffer, for its alleged misrepresentation of foreign exchange rates to its clients over years in order to pocket more profits. Even as the bank faces a series of laqsuits in this regard, it has recently taken some steps to address some of the biggest concerns regarding exchange rate transparency raised in these lawsuits. We believe that the new payment options should complement these concrete steps taken by BNY Mellon to help grow its foreign exchange business in the years to come.
And This Is Just The Beginning Of What China Has To Offer
China, the world’s second largest economy, is looking for ways to promote the use of the yuan globally – something that is seen as a necessity to ensure continued growth in local businesses for the export-driven economy. Consequently, it has opened its doors to international financial institutions in the recent past – like the pilot cross-border yuan transaction carried out by Deutsche Bank earlier this year.
The appointment of BNY Mellon as the global custodian for a Chinese fund is yet another step in that direction. The S&P 500 index QDII fund was launched in Q2 2012 by Bosera Asset Management and has the Industrial and Commercial Bank of China as its local custodian. The fund will add to BNY Mellon’s assets under custody and management of nearly $2.7 trillion.
When: Wednesday, November 14 to Thursday, November 15, 2012
Where: Hilton Arlington, Arlington, VA, USA
Led by industry veterans Stanley Borgia (Rolls-Royce NA) and Christopher Griner (Kaye Scholer) who will be Co-Chairing ACI’s 2nd National Summit on Industrial & National Security Compliance, benefit from the unique blend of in-house trade and security professionals, US government regulators and seasoned attorneys and consultants who will provide practical strategies for regulatory compliance, and security of your most valuable assets.
- DSS Priorities, Oversight, Pending Legislation and Policy Initiatives: Stanley L. Sims – Director, Defense Security Service
- Counterintelligence and Cyber Crime Update from the FBI: Robert Anderson, Jr., Assistant Director of Counterintelligence Division, Federal Bureau of Investigation
- The CFIUS Process: Mark Jaskowiak, Deputy Assistant Secretary for Investment Security, US Department of Treasury
Rolls-Royce North America, Boeing, Smiths Group, Lockheed Martin, Raytheon, Symantec, General Dynamics, iDirect Government Technologies, DRS Technologies, CACI International, Ball Aerospace & Technologies, and BAE Systems
Complete your training at Exclusive Post-Conference Working Group Sessions – November 16, 2012:
- A: DSS INSPECTIONS: A Practical Guide to Preparing for Vulnerability Assessments: Maximizing your Chances of Receiving a “Superior” Rating through Security “Enhancements” – Led by Richard Lawhorn (DSS), Jennifer Brown (iDirect Technologies) and Kenneth White (Raytheon)
- B: Technology Control Plans (TCP) and Electronic Communications Plans (ECP): The Ins and Outs of Crafting a Comprehensive TCP and ECP to Control Foreign National Access and Protect Classified Information - Led by Richard Naylor (DSS), Ted Timberlake (Global Integrated Security), and Dale Turza (Cadwalader, Wickersham & Taft)
When: Monday, November 12 to Tuesday, November 13, 2012
Where: Hilton Arlington, Arlington, VA, USA
ACI’s DCAA Audits Conference, scheduled for November 12-13 in Arlington, VA, is one of the few events that has a consistent track record in gathering key government and industry decision-makers all in one room. Past attendees have found this event to be very worthwhile, providing them with invaluable networking and best practices that they can apply to their daily work:
“Discussion content extremely timely and relevant to our company’s operations” – L-3
“Good benchmarking opportunity.” – AMETEK AEROSPACE & DEFENSE
“Great refresher. Reminds me to refocus efforts based on conference presentations. Very organized and well-run. Great variety of speakers.” – GE AVIATION
“This was informational and confirmed that our issues are experienced by a lot of other contractors. It was eye opening as to where we are going in the future with DCAA and how they will be influencing business decisions.” – SRCTec
HERE ARE MORE REASONS WHY THIS EVENT DIFFERS FROM OTHER CONFERENCES:
1. DCAA, DCMA and DPAP are all confirmed for the event:
- John Shire, Deputy Assistant Director, DCAA Policy & Plans Directorate
- Steve Trautwein , Deputy Director, Cost & Pricing Center, DCMA
- Shay Assad, Director, Defense Pricing, Defense Procurement and Acquisition Policy (DPAP)
2. In addition to CLE and CPE, you will gain best practices for addressing the most critical issues affecting your bottom line. View full agenda.
3. Meet and learn from Rolls Royce, DynCorp, CH2MHill, Lockheed Martin, Honeywell, BAE, Fluor, Alion, URS, Eaton, Huntington Ingalls Industries, and Boeing. You will also hear from leading private practice consultants and attorneys, who are recognized subject-matter experts on a wide range of complex DCAA audit issues.
4. Highly in-depth, practical sessions, including:
- Audits under the New Business Systems Rule: Upgrading Business Systems Demonstrations and Corrective Action Plans to Meet DCAA Expectations
- Operating amid the Incurred Cost Audit Backlog: The Latest on DCAA’s More Detailed Sampling, Submission and Supporting Documentation Standards
- What to Do When You Disagree with DCAA Audit Findings: When and How Far to Push Back, and Successful Rebuttal Strategies
- The Rise in DCAA Fraud Referrals to DoJ: How Recent False Claims Act Cases Have Been Won and Lost
- Labor Qualification Audits: Ensuring You Have the Required Internal Controls, Data and Documentation
- DCAA Compensation Audits: How Recent Cases Have Changed DCAA’s Approach and Expectations
When: Monday, October 29 to Tuesday, October 30, 2012
Where: Hilton San Francisco Financial District, San Francisco, CA, USA
For the first time at this event, learn how your peers are addressing are addressing the quickly evolving issue of injunctive relief involving standards essential during the Focus on FRAND session featuring insights from:
Vice President & Legal Counsel, Qualcomm
General Manager, Standards Strategy, Microsoft
Program Director of Standards and IPR, Intel
Participate in the discussion as John, Amy and Earl address:
- The public interest factors that the ITC should consider when determining whether to issue exclusionary relief in connection with a SEP that is subject to a FRAND commitment?
- Whether or not FRAND-compliant offers can/should impact the ITC’s issuance of traditional injunctive relief/exclusionary remedies
- Whether the ITC should grant a stay of delay of entry of an exclusion order in an investigation involving a standards essential patent pending review by the Federal Circuit
- How the ITC treats standards essential patents vs. other jurisdictions (US federal district court and international venues)
Don’t miss this opportunity to hear directly from the ITC Bench as they share their insights on:
- Multi-Jurisdictional IP Litigation
- eDiscovery: Thoughts and Recommendations for Practitioners on How to Streamline the Process
- Claim Construction and the Markman Hearing
- How to Obtain Approval of Your Settlement Proposal
Also, benefit from the following NEW case study and panel sessions:
- ITC – Federal Circuit Interface – addressingthe appellate dichotomy
- The Reverse Case Phenomenon – perspectives on cross party investigations in 337 actions
- Revisiting Beloit – inside the Wind Turbines case and the right to judicial review
- ITC Case Law Year in Review – inside the Year’s Top 10 ITC Cases
- From the Engineer to the CEO – how to select and prep fact and expert witnesses
Gain strategic information that will aid you in your practice during the Interactive Working Group Sessions on:
A – Enforcement of ITC Exclusion Orders at Customs
B – e-Discovery – Cost Effective Strategies for Successful Fact Finding
When: Tuesday, October 23 to Wednesday, October 24, 2012
Where: Millennium Knickerbocker, Chicago, IL, USA
American Conference Institute’s ITAR Boot Camp is scheduled for October 23-24 in Chicago. Unlike other ITAR training in the Midwest, this unique, nuts and bolts course will delve into key ITAR requirements through in-depth discussion, case studies and hands-on exercises.
While other courses feature only a handful of speakers, this event will allow you to meet and learn from a diverse faculty of senior government officials, large and smaller exporters, as well as leading private practice experts. New speakers from government, and large and smaller exporters: DTSA, Department of Homeland Security, GE Aviation, Boeing, Goodrich, Esterline, Meggitt Aircraft Braking Systems, Richardson Electronics, Raytheon, Molex, Northrop Grumman, ATK, Woodward and Eaton.
INTENSIVE FOCUS ON HOW TO CLASSIFY ITEMS, TECHNOLOGY AND SERVICES, AND THE IMPACT OF EXPORT CONTROL REFORM:
The first day of the event includes an intensive, half-day of discussion, case studies and exercises on how to classify items, technology and services under the ITAR, and identify ITAR-controlled technical data and defense services. DTSA will also provide practical guidance on its expectations for preparing ITAR licenses and agreements, and drafting CJ requests.
MORE FOCUS ON HOW TO COMPLY WITH FOREIGN, DUAL AND THIRD COUNTRY NATIONAL RULES:
The new 2012 agenda also includes two in-depth sessions on how to comply with foreign, dual and third country national rules, reconcile ITAR requirements with foreign anti-discrimination and privacy laws, and coordinate compliance efforts with your HR Department.
Intensive Pre-Boot Camp industry working groups – October 22, 2012:
- Licensing Working Group: How to Prepare ITAR Licenses and Agreements that Meet DDTC and DTSA Expectations
- IT Management of ITAR Compliance Working Group: Managing ITAR-Controlled Data and Foreign National IT Access
When: Wednesday, October 24 to Thursday, October 25, 2012
Where: Sutton Place Hotel, Chicago, IL, USA
You cannot afford to be left in the dark regarding FDA medical device regulations
Whether you are an a products liability litigator, patent counsel, business or investment expert, medical or regulatory affairs professional, or industry in-house counsel, FDA Boot Camp – Devices Edition will arm you with the tools you need to have a strong working knowledge of core FDA regulatory competencies. Now in its second year and part of ACI’s successful FDA Boot Camp franchise, the Devices Edition will take a special focus on the law and regulation of medical devices and provide you with the regulatory grounding necessary to enhance your practice.
Save the phone calls to your colleagues or other regulatory counsel for the truly complicated issues; attend ACI’s FDA Boot Camp – Devices Edition to boost your FDA regulatory IQ. The Boot Campboasts a preeminent faculty of the nation’s leading food and drug lawyers—many of whom previously served as legal counsel at FDA—who will drill you in the basics of FDA devices law and regulation.
- Tailor your experience by attending the pre-conference workshop and post-conference master class
- Stay ahead of the curve with a special focus on developing issues relating to the changes in 510(k) clearance
- Have your questions answered in a high level collaborative environment
- Obtain 2 years experience, updates and networking in just 2 days, while earning CLE credits for the year
- Learn directly from the nation’s leading members of the Food and Drug bar
Five reasons you should attend this event:
Meet and gain insights from renowned FDA devices attorneys including industry in-house counsel, Karen Weaver from CareFusion
The Master Class on Unique Regulatory Schemes for Specialized Devices: In Vitro Diagnostics and Software Classified as Devices will provide critical analysis of major recent regulations of IVDs anddevelopments in the evolving regulatory landscape of LDTs and will delve into the unique regulatory structure governing medical device software
In-depth discussion will be provided on recalls and withdrawals of devices
Get expert insights about working with the FDA and the nature of the approval process
Move through the approval process more quickly by gaining a greater understanding of the regulation of clinical trials, IDEs, 510(k) clearance, and PMAs