Archive for March, 2011« Older Entries
Mobile is the new medium for loan repayments! It’s quick, efficient, and can be done from virtually anywhere. This technology is beneficial for both parties, but has it made the MFI‘s livs easier? The following article describes the in’s and out’s of Mobile Money and the possible solutions available. This expert article has been contributed by Elizabeth Galpin of PAYG Solutions. PAYG Solutions provides cloud based technology, coupled with mobile phone applications to ensure that essential information can be transmitted by, and is available to, all system users via mobile phones, irrespective of where they are located. These solutions are of particular relevance in developing markets and rural areas, where communications are limited.
Expert Article: Has Mobile Money made the MFIs lives easier?
In Kenya, many MFI customers now use mobile money for their (mainly weekly) loan repayments. This is undoubtedly more convenient for them than taking time out of their working day to make a payment in person, or to attend a group meeting. But how has the MFI benefitted from having some or all of their loan repayments via a mobile wallet?
Handling cash is expensive and cumbersome, not to mention hazardous for the Field Officer. So, anything that helps take cash out of the equation has to be good news. Payments via mobile wallets have improved Cash flow for the MFIs– no need to wait for a Field Officer in a remote village to collect payments, make his way to the Bank and spend a large part of the day standing in a queue. Disbursing loans straight into a customer’s m-Pesa account and having repayments paid into the MFI’s account (via the ‘Pay Bill’ mechanism) has certainly meant that Field Officers are carrying less cash, which must also mean their lives have been made safer.
All is not totally rosy though…….The larger MFIs spend hours reconciling repayments – both individual and group. Additional administration resource has been drafted in to deal with this reconciliation and there is typically a backlog of around a week, for matching of mobile money repayments to loans. Take for instance the situation whereby a group leader makes a single repayment for all the members within the group. This single amount has to be analysed – does it add up to the sum of the individual repayments? If so – all well and good, but if not, this needs to be followed up manually.
Ideally, the MFI’s MIS should handle this reconciliation insofar as possible, sweeping the mobile wallet systems for ‘Pay Bill’ payments, matching up the Account number to the customer’s Loan Account and checking that the amounts tally. If they do, the customer should get an SMS, confirming that the payment has been received and processed, together with an updated outstanding Loan Balance. The loan repayment needs to be marked as Paid, and there should be no need for any manual intervention, unless the repayments don’t match the amount due. Similarly, when a Group Leader’s payment is received, as long as it adds up to the total repayments for all the individuals within the Group, each group member, as well as the Group leader should get the confirmation SMS, and all individual payments should be marked as paid for the week. Any mismatched amounts will need to be dealt with manually, and moved into a suspense account. Tools should be provided to the administrators to handle these inconsistencies as swiftly as possible.
Even more sophisticated would be the enabling of rules for each customer – here’s an example. If a customer overpays their loan, would they want the overpayment to be deposited into their Savings Account, or would they want part of the following week’s repayment to be paid ahead of time? Not all MFIs provide Savings facilities, but those that do could benefit from this extra level of convenience built into their MIS.
And finally, we all know that most developing markets now have multiple mobile wallet systems in place, so as time goes on, and the market share is distributed more evenly between these individual mobile wallet systems, payments from all should be dealt with.
Sounds like a pipe-dream? Not at all – our MIS software is specifically designed to handle the reconciliation of repayments, keeping customers informed at all times by SMS. Field Officers are also provided with tools (an app which runs on their handsets) for all essential transactions and queries, so that they are able to work out in the field with as much information to hand as possible. They can even request a list of all customers whose loans are due for renewal within 1, 2 or 3 weeks. Working with companies that specialise in the ‘pay bill’ mobile wallet integration in-country, such as Kopo Kopo, Zegetech technologies and Paynet, we’re able to provide the automatic reconciliation on all loan repayments. So – we give the Field Officers the tools, the customers constant feedback via SMS, as well as facilities to query their loans and savings, and we make the office workers lives easier by leaving only the exceptions for them to deal with.
The initial m-Pesa trials with Faulu weren’t popular, because it was felt that there was a breakdown in the group ethic and the lack of weekly group contact meant that more delinquency was creeping in. But MFIs are now realising that it isn’t necessary to have weekly meetings with all members of the group, to collect the money. As long as some continuity is maintained, the group will continue to operate as an entity, with (much less frequent) meetings being used for networking, mentoring and training, rather than just being focussed on collection of money.
In many cases, we know that it would be beneficial for Field Officers to double up as mobile money Agents, especially in the rural areas. In that way the cash can be recycled within the community. Fewer trips to the nearest bank by the Agent / Field Officer will benefit everyone, and, provided the Field Officer has a way of recording the cash loan repayment on the system in real-time, it means that the customer knows his loan repayment has been recorded and processed on the system, and makes the cash available for the next customer who may be visiting the Agent to withdraw cash from his mobile wallet. In time, more and more people will pay their bills via their mobile wallet, and this will bring about changes in the rural situation, but in this way, there will be constant evolution and utilisation of new technologies.
Things they are a-changing…
Bertrand has significant investment funds experience at Luxembourg financial centre. At present he is a consultant in fund administration and research fellow in microfinance at CERMi. Bertrand is also a P.h.D. candidate at University of Mons (UMONS), Belgium. Mr.Moulin’s main research topic is Microfinance Investment Vehicles (MIVs) for Sub-Saharan Africa. His specialties reside in investment funds and Microfinance (more specifically Microfinance Investment Vehicles – MIVs).
The Rationale of Considering Microfinance Plus Programs (January 11th, 2011)
Contact Bertrand Moulin
Expert Article: Prize Promotions Near Top of FTC Consumer Complaint List. Do Marketers Know the Law?
Prize promotions as marketing devices are on the rise, but do marketers know the law? Complaints have doubled since 2008 and it shows marketers are either ignoring the law or are unaware of government statutes. This weeks expert article is contributed by Expert Speaker, Kyle-Beth Hilfer. Kyle-Beth is a Advertising/Marketing Law Specialist and Arbitrator at Kyle-Beth Hilfer, P.C.
Prize Promotions Near Top of FTC Consumer Complaint List. Do Marketers Know the Law?
On March 8, 2011, the FTC released its list of Top Consumer Complaints areas for 2010. In 4th place out of ten, the category of “Prizes, Sweepstakes, and Lotteries” had 64,085 complaints, accounting for five percent of all complaints the FTC received. (See http://1.usa.gov/dRX5nC.)
The category falls within a broader Fraud division and is defined to include: “promotions for ‘free’ prizes for a fee; foreign lotteries and sweepstakes offered through the phone, fax, e-mail or mail; etc.” Within the category, the FTC reported more than three times the number of complaints in the area of “prizes, sweepstakes, and gifts” than “lotteries and lottery ticket buying clubs.”
The number of complaints in this category has almost doubled since 2008. A close look at the report shows that in many states, complaints in this area rank in the top two or three categories. In Minnesota, it was the top complaint category with ten percent of complaints. One has to wonder what is going on in Minnesota!
Reading the FTC report should give sweepstakes promoters pause. The FTC’s statistics suggest that the use of prize promotions as a marketing device is on the rise. At the same time, the rise in complaints suggests that many marketers either are unaware of the morass of governing statutes or they do not care to follow the law. Ignorance of the law is no defense, however, and intent to ignore the law can lead to stiffer financial and even criminal penalties.
Under the Obama Administration, we are seeing an emboldened, activist FTC at work. State regulators are following suit. Companies that are using prize promotions need to be aware that this is a highly regulated area. They should partner with specialized legal counsel, early in the process, to help structure promotions that pass legal muster.
Prize promotions are uniquely qualified as marketing devices in the social media and mobile marketing arenas. The legal issues require analysis in light of these unique platforms’ capabilities. Does requiring a consumer to like a Facebook page constitute consideration to render a sweepstakes an illegal lottery? Probably not, but requiring multiple Foursquare checkins from various locations might taint a promotion without an alternate method of entry. Can a jingle contest incorporate public judging via Facebook or Twitter? Possibly, but only if chance does not overtake the objective criteria for judging. Can a marketer require text message entry into a sweepstakes? Text messaging has not permeated the marketplace sufficiently to obviate the current need for an alternate method of entry.
Implementing a prize promotion requires thoughtful analysis of the elements of prize, chance, and consideration to be sure that the promotion is not an illegal lottery. In addition, these promotions should be subject to detailed analysis from a legal, business, and public relations perspective to avoid the increasing trend in consumer complaints before the FTC.
© Kyle-Beth Hilfer, P.C. 2011. Kyle-Beth Hilfer, Esq. specializes in advertising, marketing, promotions, intellectual property and new media law. She is also Of Counsel to Collen IP, a full service intellectual property law firm. For more information about her law practice and more blog posts, please visit www.kbhilferlaw.com.
Thomas Fox has practiced law in Houston for 25 years. He is now assisting companies with FCPA compliance, Risk Management and international transactions. He was most recently the General Counsel at Drilling Controls, Inc., a worldwide oilfield manufacturing and service company. He was previously Division Counsel with Halliburton Energy Services, Inc. where he supported Halliburton’s software division and its downhole division, which included the logging, directional drilling and drill bit business units.
Tom attended undergraduate school at the University of Texas, graduate school at Michigan State University and law school at the University of Michigan.
Tom writes and speaks nationally and internationally on a wide variety of topics, ranging from FCPA compliance, indemnities and other forms of risk management for a worldwide energy practice, tax issues faced by multi-national US companies, insurance coverage issues and protection of trade secrets.
- How Does the FCPA Apply to Your Business? (January 24th, 2011)
- Franchising and the FCPA (January 19th, 2011)
- The FCPA and Mergers and Acquisitions (December 8th, 2010)
- What’s in a Name Under the FCPA (November 17th, 2010)
- How to Risk-Base Supply Chain Vendors Under the FCPA (November 17th, 2010)
- Proposed Reforms to the FCPA: the Compliance Defense and Respondeat Superior (November 8th, 2010)
- US Sentencing Guidelines Changes Becomes Effective November 1st (October 30th, 2010)
- The Six Principles of a Best Practices Anti-Corruption Program Under the UK Bribery Act Guidance (September 23rd, 2010)
- Promotional Expenses Defense Under The FCPA (August 24th, 2010)
- The Top 3 FCPA Hits of 2010 (July 14th, 2010)
Contact Thomas Fox
Phone: 1-832-744-0264 (US), +44 (0) 23-92006548 (UK)
Kyle-Beth Hilfer has over 20 years experience as an attorney specializing in advertising, marketing, promotions, intellectual property, and new media law. Ms. Hilfer routinely advises on all aspects of advertising, marketing, and direct mail campaigns.
As an advertising law specialist, Ms. Hilfer performs copy clearance, reviews claim substantiation, obtains third party licenses, and ensures regulatory compliance. In addition, she advises on specific marketing techniques, such as negative options and advance consent marketing, and behavioral marketing. Ms. Hilfer creates, structures, and ensures legal compliance of promotions (both off-line and on-line), including sweepstakes, contests, premiums, auctions, continuity programs, loyalty programs, instant win games, incentives, and coupons.
In the social and new media areas, Ms. Hilfer helps clients leverage social media platforms while protecting their brands and intellectual property. In particular, Ms. Hilfer counsels on such issues as managing employees in social media, running prize promotions on social media platforms, user-generated content, e-commerce agreements, blogs, affiliate marketing, mobile marketing, testimonials and endorsements in cyberspace, and e-mail marketing.
Well-versed in intellectual property law, Ms. Hilfer routinely advises companies on how to transform their ideas into legally protected copyrights and trademarks. She helps develop long-term business plans to maximize the value of intellectual property portfolios, and she offers strategies for exploiting intellectual property in a global marketplace.
Ms. Hilfer is a graduate of Yale College and Harvard Law School. She maintains her own private law practice and is also Of Counsel to Collen IP. She is an arbitrator for the American Arbitration Association, serving on the commercial and intellectual property panels and hearing large, complex cases. In addition, she serves on the Board of Editors for The Intellectual Property Strategist, an American Law Media publication. She is a guest blogger for Global Strategic Management Institute’s Social Axcess social media blog, and she has been quoted by the media as an expert on social
media law, advertising law, and intellectual property law issues.
You can subscribe to Ms. Hilfer’s blog at www.kbhilferlaw.com/blog
- Drafting Social Media Policies to Minimize Legal Risk of an NLRB Complaint
- Kyle-Beth Hilfer quoted in The Prepaid Press about Groupon Class Action Lawsuits ( May 18th, 2011)
- Five Common Legal Errors in Internet and Social Media Marketing ( May 17, 2011)
- Privacy Policies and Data Collection(April 1st, 2011)
- Prize Promotions Near Top of FTC Consumer Complaint List( March 28th, 2011)
Contact Kyle-Beth Hilfer
Kyle-Beth Hilfer, P.C.
LinkedIn Profile: http://www.linkedin.com/in/
This expert educational article has been contributed by Lea Fowler. Lea is Co-Founder of ERISA Revenue Solutions. Her article describes how ERISA can be used to recover denials from commercial payers. According to Lea, ” ERISA truly is the secret weapon that all types of providers can use to increase their revenues with minimal impact on their current operations. There are a dozen or so innovative pioneers in the medical community currently using this process to help recover money that their internal processes were unable to do.”
You may contact Lea via email at firstname.lastname@example.org
ERISA, the Secret Weapon to Recover Provider Revenues
As you will see in the rest of this article ERISA can be used to recover on denial reasons such as medical necessity, pre-authorization, excluded/non-covered, experimental and investigational, and usual, customary and reasonable. ERISA appeals focus on the contract between the employer and the employee vs. the traditional method of hospital appeals which is based on the contract between the provider and the insurance company. ERISA also allows for
the ability to go back to January 1, 2003 on denied claims and appeals.
ERISA is a federal law that was signed into effect in September 2, 1974 and reaffirmed as a vital part of the Healthcare Bill signed into law on March 23, 2010. Aetna v. Davila, June 21, 2004 a United States Supreme Court unanimous ruling confirms that ERISA supersedes state law in dealing with issues involving employee benefits such as health care insurance:
“Held: Respondents’ state causes of action fall within ERISA §502(a) (1) (B), and are therefore completely pre-empted by ERISA §502 and removable to federal court. Pp. 4—20.
(a) When a federal statute completely pre-empts a state-law cause of action, the state claim can be removed. See Beneficial Nat. Bank v. Anderson, 539 U.S. 1, 8. ERISA is such a statute. Because its purpose is to provide a uniform regulatory regime, ERISA includes expansive pre-emption provisions, such an ERISA §502(a)’s integratedenforcement mechanism, which are intended to ensure that employee benefit plan regulation is “exclusively a federal concern,” Alessi v. Raybestos&nbhyph;Manhattan, Inc., 451 U.S. 504, 523. Any state-law cause of action that duplicates, supplements, or supplants ERISA’s civil enforcement remedy conflicts with clear congressional intent to make that remedy exclusive, and is therefore pre-empted. ERISA §502(a)’s pre-emptive force is still stronger. Since ERISA §502(a)(1)(B)’s pre-emptive force mirrors that of §301 of the Labor Management Relations Act, 1947, Metropolitan Life Ins. Co. v. Taylor, 481 U.S. 58, 65—66, and since §301 converts state causes of actions into federal ones for purposes of determining the propriety of removal, so too does ERISA §502(a)(1)(B). Pp. 4—7.
(b) If an individual, at some point in time, could have brought his claim under ERISA §502(a)(1)(B), and where no other independent legal duty is implicated by a defendant’s actions, then the individual’s cause of action is completely pre-empted by ERISA §502(a) (1)(B). Respondents brought suit only to rectify wrongful benefits denials, and their only relationship with petitioners is petitioners’ partial administration of their ERISA-regulated benefit plans; respondents therefore could have brought §502(a)(1)(B) claims to recover the allegedly wrongfully denied benefits. Both respondents allege violations of the THCLA’s duty of ordinary care, which they claim is entirely independent of any ERISA duty or the employee benefits plans at issue. However, respondents’ claims do not arise independently of ERISA or the plan terms. If a managed care entity correctly concluded that, under the relevant plan’s terms, a particular treatment was not covered, the plan’s failure to cover the requested treatment would be the proximate cause of any injury arising from the denial. More significantly, the THCLA provides that a managed care entity is not subject to THCLA liability if it denies coverage for a treatment not covered by the plan it administers. Pp. 7—12.” (Thomas, 2004)Reference: AETNA HEALTH INC. V. DAVILA (02-1845) 542 U.S. 200 (2004) 307 F.3d 298, reversed and remanded
In addition to the fact that ERISA supersedes all state law is the fact that you can also recover on denied claims that go all the way back to January 1, 2003. Provider/Insurance Company contracts historically favor the insurance company especially when it comes to appeal restrictions placed on the provider. Generally, insurance companies allow up to 60 days after denial for providers to appeal. Under ERISA if the Explanation of Benefits (EOB) does not meet the criteria set forth in section (g) of the Federal Register then the applicable limitation found in the employee’s Summary Plan Description (SPD) does not apply until all the criteria of section (g) are met. In Spectrum Health v. Valley Truck Parts, May 30, 2008, and Solien v. Raytheon LTD Plan, June 02, 2008, the court determined that the benefit denial notification and EOB, explanation of benefits, issued to the participant were insufficient to trigger 180 days according
to DOL guidelines ERISA § 2560.503-1(g).
Medical necessity, denial of days for pre-authorization and treatments that were deemed experimental and investigational are major issues for clients I have helped in the past. This is further evidenced by research completed by the Center for American Progress article Insurers’ Black Box in which Wendell Potter, a former senior public relations executive for Cigna Corp. states:
“Claims denials are probably the most effective way the industry has to manage medical expenses.” (Paltrow, 2009)
ERISA § 2560.503-1(h) deals very effectively with these denial reasons with secondary support by each state’s utilization review statutes.
In the case of excluded/non-covered denials ERISA states if the Summary Plan Description (SPD) does not specifically list the excluded/non-covered service in the Exclusions section then that service is payable. I personally recovered over one million dollars for an implantable device supplier using this strategy. The major reason for this out-of-network client’s denials was that as a third party supplier they could not bill for their own devices even though the hospital did not pay in advance for the devices. Two major insurance companies actually advocated fraudulent billing by the hospitals so this client would receive the money owed to them. As I am sure you are well aware, most provider contracts state that anything used in a surgical procedure is included in the payment for the surgery. There are also carve outs for implantable devices but they are becoming the exception rather than the rule. Obviously, the insurance company wants to pay less money therefore, they want the provider to bill for the device instead of the actual supplier. Unless the Summary Plan Description specifically states that the implanted device is excluded/not covered or that third party device suppliers cannot bill for their supplied equipment then the device has to be paid for per the Summary Plan Description.
In regard to out-of-network providers whose denials are primarily made up of exclusions and usual, customary and reasonable reasons ERISA has very specific requirements that the payer must fulfill in order to justify these denial reasons. I previously covered the exclusions aspect so the focus will now turn to usual, customary and reasonable. Both the Department of Labor (DOL) and ERISA specifically state that any rates, tables, methodologies, etc. used in the
determination by the payer must be supplied upon request. Payers are not inclined to release this information for “proprietary” reasons and are more willing to either pay or settle on these cases. On February 13, 2008 New York Attorney General Andrew M. Cuomo launched an industry wide investigation into a scheme by health insurers to defraud consumers by manipulating reimbursement rates. His efforts resulted in the discontinuance of Ingenix (an out-of-network repricing company) being used by several major payers in New York and a fifty million dollar
settlement by United Healthcare (UHC) to start up an independent database for usual, customaryand reasonable data.
ERISA is not the answer for every situation though, there are certain types of plans that ERISA does not cover. Medicare, Medicaid, school plans, church plans, workers compensation, military plans, governmental plans, and individual plans are not covered under ERISA. This is not to say that recovery cannot be done on some of these plans. I have successfully recovered money for clients on church, school and individual plans using non-ERISA methods. With the exceptions listed above under U.S. Code §1002 any employer who supplies health insurance asan employee benefit is subject to ERISA.
“For purposes of this subchapter:
(1) The terms “employee welfare benefit plan” and “welfare plan” mean any plan, fund, or program which was heretofore or is hereafter established or maintained by an employer or by an employee organization, or by both, to the extent that such plan, fund, or program was established or is maintained for the purpose of providing for its participants or their beneficiaries, through the purchase of insurance or otherwise,
(A) medical, surgical, or hospital care or benefits, or benefits in the event of sickness, accident, disability, death or unemployment, or vacation benefits,
apprenticeship or other training programs, or day care centers, scholarshipfunds, or prepaid legal services “
This article is intended for basic education purposes so I apologize that detail was not given in how to apply the court cases or sections of ERISA referred to above. I would be happy to further educate anyone who is insightful enough to grasp these concepts in an effort to increase their revenues with little or no cost to them. My name and contact information appears below.References: Paltrow, S. (2009, October 21). Insurers’ black box
Practical Preparedness and execution strategies for implementing compliant practices and managing heightened risks.
With every recall presenting unique challenges and coming under increased scrutiny, ACI’s Summit on Drug and Device Product Recalls will bring together industry leaders who will share with you their proven strategies for determining when, and how, to execute a recall and communicate effectively with the FDA throughout the process. The program faculty includes experts from Eli Lilly, Medtronic, Pfizer, Biogen Idec, Roche, C.B. Fleet, Covidien, Integra LifeSciences and Genentech as well as distinguished legal and public relations professionals with extensive industry experience in managing and responding to recalls. They will show you how to expertly weigh the different risks and available options when a manufacturing issue or adverse event arises, and prepare you to develop an effective strategy. There will be special focus on how to meet the expectations of the FDA when performing a voluntary recall, on increasing your company’s “recall readiness” and on minimizing the risk that the recall will open the door to costly litigation.
Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals
May 2, 2010 * Marriott New York Downtown * New York City
This hands-on course which is co-located with ACI’s Paragraph IV Disputes conference will provide you with an in-depth review of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as well as other IP and regulatory basics relative to small molecules and biologics. The knowledgeable faculty will lay the necessary foundation for you to comprehend thoroughly the dynamics of the IP and regulatory backdrop underlying every Paragraph IV dispute in addition to providing an introduction to biosimilars.
Sessions at this course include:
- · The FDA Approval Process for Drugs and Biologics: A Guide for Life Sciences Patent Lawyers
- · IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More
- Patent and Non-Patent Exclusivity
- Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability
- Exploring Patent Term Adjustment and Patent Term Extensions and Understanding their Applicability to Drugs and Biologics
This is the perfect course for new associates, attorneys who are new to this area of those in need of a refresher and update on some vital regulatory and IP components that are essential to Paragraph IV litigation and the emerging biosimilars landscape.
Receive a special discounted rate to this course by registering for ACI’s 5th anniversary Paragraph IV Disputes conference.
March 14th, 2011
in Advertising & Marketing |
The pharmaceutical industry is not shying away from using the Internet to promote meds to doctors. According to Pharmalot, new analysis shows more than 150 drugs were marketed for the first time using online details and events during the first nine months of 2010, which marks a new record, and makes it more critical than ever to ensure your digital marketing strategy is compliant.
American Conference Institute is proud to announce its 9th Expert Guide to Advertising, eMarketing & Promotions for the Pharmaceutical Industry, taking place March 14- 15, 2011 in Philadelphia . Featuring special sessions led by key members of the DOJ, and the counsel responsible for regulating pharmaceutical advertisng. Here, you will develop strategies to effectively respond to the government, and tailor your advertising program in line with government expectations.
Hear from leading government regulators actively involved in pharma advertising cases, including:
Lesley A. Fair, Senior Attorney, Bureau of Consumer Protection, Federal Trade Commission;
Gene Fishel, Senior Assistant Attorney General and Chief, Computer Crime Section,
Virginia Attorney General’s Office;
Douglas F. Gansler, Attorney General, Maryland Attorney General’s Office;
Margaret Hutchinson, Chief, Civil Division, Eastern District of Pennsylvania,
U.S. Department of Justice;
John Krayniak, Assistant Attorney General and Senior Counsel – Medicaid Fraud Section, New Jersey Attorney General’s Office;
Sondra Mills, Trial Attorney, Office of Consumer Litigation, U.S. Department of Justice; and
Ernest S. Voyard Jr., Regulatory Counsel, Division of Drug Marketing, Advertising, and Communications, U.S. Food and Drug Administration
March 14th, 2011
in Pharmaceuticals / Biotech / Life Sciences |
Regulatory Guidance, Operational Efficiencies and Proven Strategies for Global Clinical Supply Chain Excellence
Don’t miss your chance to hear directly from the FDA and TSA regarding regulatory compliance and fundamental importing/exporting opportunities for your supply distribution.
In today’s drug development climate, clinical supply professionals face a unique set of challenges including adhering and complying with stringent regulations, using specialized temperature packaging and monitoring devices, evaluating cost-effective and validated distribution processes, shipping to and from research labs or hospitals and many more.
ACI’s Clinical Supply Chain Optimization Conference will equip you with strategies,optimization tools and insight into leading edge technologies for effectively executing successful future complex on-time clinical trials. Additionally, discover novel strategies for reducing time-to-market on future drug products through successful trial execution, saving huge project costs in the process.
Register now and Gain Insight into:
- Building a project management core competency team within your clinical supply chain
- Meeting and complying with US regulatory requirements for importing clinical materials
- Completing and successfully managing overseas and emerging market clinical trials, including real-life case studies
- Examining the benefits of using IVRS to enhance your clinical supply management
- Developing and Improving your trial relationship with your CRO to enhance supply
- Effective implementation of cost-effective transportation and cold chain for your clinical supplies
- Discovering key techniques and proven strategies to minimizing drug supply issues during global clinical trials
- Predictive patient recruitment and supply modeling to ensure successful completion of clinical trials
- Identifying and eliminating waste while maximizing resources within your clinical supply forecasting
Featuring leading global clinical supply chain experts including Merck & Co., Pfizer, GlaxoSmithKline, Sunovion Pharmaceuticals, Genzyme, Takeda, Allergan, Human Genome Sciences, Otsuka Pharmaceuticals, Regeneron Pharmaceuticals, Vertex Pharmaceuticals, Medtronic, Athersys, OSI Pharmaceuticals and many more multiple-sized drug development organizations.
Additionally, do not miss the focused pre-conference workshops on “Overcoming the challenges of managing successful global trials” and “Quality and efficiency for cost and temperature controlled transportation of your clinical supplies”.
This is a unique opportunity to hear from and network with leading pharmaceutical, biotech and clinical research organizations who have cut cycle time and cost from their clinical trials.