Posts Tagged ‘Regulatory’« Older Entries
January 20th, 2016
in Pharmaceuticals / Biotech / Life Sciences |
When: Thursday, November 15 to Friday, November 16, 2012
Where: Gaylord National Resort & Conference Center, Washington, DC, USA
Join hundreds of in-house counsel, ethics & compliance executives, forensic accountants, FCPA, securities and corporate governance attorneys from around the globe for ACI’s 28th National Conference on the Foreign Corrupt Practices Act.
The 2012 program will feature the following NEW interactive discussions and case study panels:
- What Not to Do and Lessons Learned from the Most Costly FCPA Compliance Mistakes
- Friend or Foe? How to Survive an FCPA monitorship
- Creating a Home for the Whistleblower in a Bounty Hunter
- How to Effectively Communicate with the Board and Ensure Board Buy-in and Support of Your FCPA Compliance Program
- Navigating Diverging Client Interests during an FCPA Government investigation
- Inside the Defense of the Lindsey Manufacturing, Africa Sting and O’Shea Prosecutions
Hear from Senior U.S. DOJ and SEC Officials on:
- USDOJ Guidance on the FCPA
- SEC “Neither-Admit-Nor-Deny” Settlement Policy
- The Key FCPA Cases of 2012 and Current Enforcement Priorities
- Where Companies Go Wrong on FCPA Compliance
- Trip Wires in FCPA Internal Investigations
- Response to Whistleblower Allegations
- Disclosure, Cooperation and Global Compliance Expectations
- What Effective FCPA Books and Records Should Look Like
When: Thursday, October 18 to Friday, October 19, 2012
Where: The Carlton Hotel, New York, NY, USA
Prepare to meet the anticipated challenges of ‘OTC drugs with conditions of safe use’ as you master existing legal and regulatory protocols for non-prescription pharmaceutical products.
FDA’s proposed introduction of a new paradigm for ‘OTC drugs with conditions of safe use’ (which some industry observers have referred to as a third class of drug product or ‘behind the counter’/ ‘BTC’ products ) will put a new twist on existing legal and regulatory protocols and product commercialization in the OTC space. Self-diagnosis and self-care, two basic tenants of the current OTC paradigm may be supplemented with the assistance of a pharmacist and rapid diagnosis testing, thus leading to a multitude of questions ranging from scope of FDA authority to potential liabilities.
To help you make sense of this new proposal and its potential impact on existing legal and regulatory structures in the OTC environment, ACI has developed the Legal, Regulatory and Compliance Forum on Over the Counter Drugs. Over two dozen legal and regulatory OTC experts from such leading companies as GlaxoSmithKline Consumer Healthcare; Merck & Co., Inc.; Novartis Consumer Health, Inc.; Perrigo Company; and Pfizer will present at this unique industry event. This distinguished faculty will address existing and anticipated challenges affecting such core OTC functions as:
- Advertising and promotion
- Trademarks, trade names and line extensions
- The modernization of the monograph system
- Rx to OTC switches
- AER protocols
- Recalls and remediation strategies
Additionally, key FDA and USP representatives will present at this event on such critical and industry game changing matters as:
- The Ramifications of FDA’s Proposed New Paradigm for OTC Drugs with Conditions of Safe Use
- Nicholas E. Beshara, Associate Chief Counsel, Office of the Chief Counsel
United States Food & Drug Administration
- Trends in Recent OTC Enforcement Actions and Litigation:Lessons Learned for Risk Mitigation and Compliance
- Eric Blumberg, Litigation Deputy, Office of the Chief Counsel
United States Food & Drug Administration
- Modernizing the Monograph System and the OTC Drug Review Process in Light of New OTC Drivers and Technologies
- Matthew Van Hook, Assistant General Counsel, Compendial Sciences
The United States Pharmacopeial Convention
When: Thursday, October 11 to Friday, October 12, 2012
Where: Westin San Francisco Market Street, San Francisco, CA, USA
You know what’s swirling in the industry: “All consumers need, and deserve, products which are safe and whose costs and risks are clear upfront. Yet right now prepaid cards have far fewer regulatory protections than bank accounts or debit or credit cards. That’s why we are launching a rulemaking to promote safety and transparency in this emerging market.” – CFPB Director Richard Cordray
In response, ACI’s 6th National Prepaid Card Compliance Summit, run for the first time on the west coast, will bring together industry experts from around the nation to examine the prepaid industry’s most pressing legal, compliance, and regulatory concerns.
In attendance already include:
CFPB • DOJ • FDIC • FinCEN • OFAC • TFFC • American Express • Bancorp • Blackhawk Network • Visa • Wells Fargo • Western Union • Fiserv • Galileo Processing • Green Dot • MasterCard • MetaBank • Netspend • Plastic Jungle • Brightwell Payments • NBPCA • Obopay • Consumers Union • Illinois DCEO • Ala. Securities Commission • CSBS • Former Wash. State DFI
Join your colleagues and clients and receive critical updates and expert insights on:
- The evolving regulatory paradigm: New initiatives from the federal regulators coupled with mounting pressure from the states
- Continued guidance on FinCEN’s Prepaid Access Rule: evaluating the impact of the rule and implementing new initiatives to ensure compliance
- The CFPB and prepaid cards: Evaluating the jurisdictional parameters and authority of the bureau, the final rule on International Remittance Transfers, advance notice of proposed rulemaking and new procedural rules for nonbank supervision
- The Durbin Amendment: applicability, exemptions, impact and looking ahead to future implications
- Developing, implementing, and maintaining AML compliance programs in the prepaid context
- Evaluating your current fraud deterrence program in light of recent fraud risk, including diversion of government benefits
- The new “A” in UDAAP, privacy, third-party relationships and marketing: regulatory and compliance considerations for prepaid cards
- International prepaid card compliance landscape: the regulatory and business environments in key markets abroad, lessons learned for the U.S. market, and strategies for ensuring compliance with evolving global regulations
- Remote deposit capture and reloading
- And much more…
April 22nd, 2012
in International Trade & Defense |
A Groundbreaking Conference Designed to Address the Unique Challenges of Importing into Brazil. Join an elite group of Trade Executives and learn from your peers how to Minimize Duties and Resolve Complex Brazil Customs Challenges.
Following the tremendous success of its flagship trade compliance conferences in the United States, Europe and Asia, American Conference Institute is pleased to introduce its inaugural Brazil Summit on Customs & Import Compliance, a groundbreaking international conference addressing the complex customs compliance challenges in Brazil.
In the last year, the Brazilian Government has made several changes to customs regulations and duties, and quadrupled the number of investigators in the Ministry of Development, Industry and Foreign Trade. Customs inspections, origin investigations and valuation disputes are all increasing in frequency and make it imperative for multinationals importing into Brazil to revisit their import compliance strategy. In order to succeed in this evolving regulatory and heightened import enforcement environment, multinationals must stay ahead of the latest Brazil Customs requirements and build a robust compliance program that is effective on the ground. Failure to act is otherwise likely to result in border delays, stiff penalties and missed production and delivery deadlines.
This unique and insightful conference is designed to provide Brazil trade compliance executives with practical import compliance and duty saving strategies. Program highlights include:
An In-Depth Look at Customs Compliance Programs for Brazil:
Benefit from a practical discussion on the core components of an effective customs compliance program for Brazil imports. Learn how to customize your reporting structure, compliance processes, internal controls and training strategies to address the unique risks of your business.
An Unprecedented Opportunity to Benchmark with your Peers at:
Tyco, Nike, Weatherford, ABB, Nestle, Novartis, Baker Hughes, Cisco, Bayer, LATAM Airlines, DuPont, PepsiCo, Microsoft, Hershey and Covidien.
The View from Customs HQ:
Hear what HQ perceives to be an effective compliance program and learn how global trade compliance professionals coordinate trade compliance and foster uniformity in a global organization.
Even the most seasoned drug and device lawyers practice mock trials to improve their advocacy and litigation skills. Why would you want to do this? Several reasons are:
• IDENTIFY the right (and wrong) jurors during voir dire
• MAXIMIZE the ability to reach jurors during opening and closing statements
• RECONCILE research findings through cross-examination of the plaintiff; prescribing/treating physician; and the plaintiff’s epidemiologist, regulatory/FDA expert, and pharmacologist
• COMMUNICATE causation and scientific data to a jury through direct examination of the company witness; in-house scientist; company regulatory professional; and the defense epidemiologist, FDA expert, and pharmacology expert
It does not end there. Recent drug and device products liability verdicts are staggering. Maximizing your ability to reach and persuade jurors
who think the industry is untrustworthy is crucial to success. Benchmark your advocacy strategies and tactics at the ultimate interactive trial skills and jury communication event with American Conference Institute‘s Drug and Medical Device Litigation.
Eliminating the risk and cost of a trial in a drug or medical device products liability case, whether by motion to dismiss or summary judgment, is the goal. However, sometimes this is not possible; sometimes fighting it out at trial is the only recourse. At trial you don’t know the results until the jury speaks and they have spoken loudly in the past 18-24 months, delivering verdicts of $134 million, $51 million, $32 million, and $13 million. It’s no secret that these verdicts have a significant impact on a company’s bottom line. And as plaintiff attorneys use sympathetic plaintiffs, media bias, and poor juror perception of the drug and device industries to their advantage in high-risk and costly products liability trials, there’s no room for error in the courtroom.
ACI, creators of Drug and Medical Device Litigation, the annual December conference that has been the industry’s premier products liability litigation event for 13 years, once again brings you its summer advocacy companion: 2nd Annual Drug and Medical Device On Trial, the ultimate trial skills and jury communication event for pharmaceutical and medical device manufacturers and their counsel. Drawn from one central adverse event fact pattern (see page 6-7 infra), this event will feature top defense litigators who are in the trenches making news and setting precedents demonstrating and offering novel jury communication strategies on the most challenging aspects of drug and device products liability trials, including:
• jury selection
• opening and closing statements
• cross-examination of the plaintiff; prescribing/treating physician; and the plaintiff’s epidemiologist, regulatory/FDA expert,
• direct examination of the company witness; in-house scientist; company regulatory professional; and the defense
epidemiologist, FDA expert, and pharmacology expert
June 19-20, 2008 |The Carlton on Madison Avenue | New York City
The reinsurance industry has become a global marketplace and regulatory
frameworks are beginning to reflect this fact. Insurance and reinsurance
companies are going to be heavily impacted by new regulations in the coming years, whether they take the form of modified collateral requirements and the movement towards a unified regulatory system in the US, or the Reinsurance Directive and Solvency II in the EU. Further, in order to capitalize on new and vibrant reinsurance markets, it is imperative that reinsurance professionals have a thorough understanding of the emerging regulatory systems in Asia and Latin America.
Key points for success:
• Adapt to changing collateral requirements
• Anticipate and prepare for a unified US regulatory system and the
impact it will have on the reinsurance industry in the US and abroad
• Operate effectively under the new EU reinsurance paradigm
• Implement new risk management procedures in order
to ensure regulatory compliance
• Understand how emerging regulations will impact run-off operations
• Comply with regulations governing the convergence
of capital markets and reinsurance
ACI’s Advanced Forum on Reinsurance Regulation will provide you with
the expert insights and strategic advice that you need to navigate the hurdles
and take advantage of the opportunities provided by these evolving regulatory regimes.
Take advantage of this opportunity to network with reinsurance industry
experts while gaining the knowledge and insights that you need in order to
navigate the evolving regulatory landscape. This must-attend event will fill up quickly, so register today
June 17th, 2008
in Advertising & Marketing |
June 17-18, 2008 • The Latham Hotel Georgetown • Washington DC
Industry insights straight from the enforcers
Top regulators and industry leaders tell you what they’re focusing on now and what they expect for optimum compliance:
Mary K. Engle
Division of Advertising Practices
Federal Trade Commission
Lesley A. Fair
Bureau of Consumer Protection
Federal Trade Commission
Andrea C. Levine
Director, National Advertising Division
Senior Vice President, CBBB
Peter C. Marinello
Director, Electronic Retailing
National Advertising Review Council
R. Glenn Yabuno
San Bernadino County District
Companies that advertise goods and services can find themselves subject to
government investigations and millions of dollars in fines and penalties for
violating federal and state regulations. This applies especially to companies that target children with their advertisements, make results claims about their products or are currently mounting green initiatives. Regulatory bodies such as the FTC, FCC, and state consumer enforcement divisions are turning a critical eye toward potential violations and violators.
The best means of avoiding these disastrous results is to know exactly which
advertising and marketing practices are on the government’s radar screens and how you are expected to comply with new and existing regulations…
The expansion of behavioral and viral marketing and inception of new social
networking sites, high-tech branding efforts, and interactive brand integration have created new areas of liability overnight. Additionally, wireless communications is an ever growing medium that falls under the purview of several federal regulatory agencies; however, understanding the FTC’s willingness, ability and current activity in this area of regulation is critical for anyone engaging in wireless advertising efforts.
Whether you have attended American Conference Institute’s Advertisers’ &
Marketers’ Regulatory Summit before or if this will be your first ACI
conference, you are sure to benefit from our updated, highly constructive and valuable panels. As always, this program is specially tailored to offer the very best of hands-on sessions and materials that you can apply directly to your practice. This year, we are introducing new faculty members from well-recognized positions within the regulatory agencies and industry critical self regulatory bodies as well as key advertisers and advertising companies, who are poised to bring you fresh perspectives on developments in:
• Judging the importance FTC’s recent settlements and key holdings
• Advanced procedures in building compliance systems
• Preventing unnecessary liabilities thought advanced claim substantiation
• Managing the complexities presented by national advertising campaigns
• Improving the quality and value of communications between your clients
and regulatory agencies
You can also add value to your attendance by taking advantage of our interactive workshop Unlocking the Complexities of the Doctrine of Substantiation. Register now to ensure your place at what is sure to be a sold-out event!
June 9th, 2008
in Advertising & Marketing |
June 9-10, 2008 | The Carlton | New York, NY
Gain industry insights into how to:
• Update or establish a compliance protocol for implementing
the requirements of the new GMP rule
• Revise your procedures for receiving, reporting, and maintaining
information on adverse events
• Market your product in a manner that will withstand regulatory
scrutiny while also protecting your brand and trademarks
• Utilize clinical research and scientific evidence to substantiate
• Insulate your company from liability when manufacturing, importing,
and selling products in international markets
Dietary supplement and food regulation has exploded over the last year.
In response to public and Congressional outcries for an active regulatory scheme to address the overall safety of dietary supplements and functional foods, the FDA responded in 2007 with the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Since the passage of the Act, the government has issued several guidances to industry over the past year clarifying the newly-imposed requirements for GMPs and adverse event reporting.
Revisit compliance programs in light of new regulatory requirements
Outlining progressive deadlines for companies of various sizes, the final GMP rule requires companies to completely re-evaluate their manufacturing practices for safety and efficiency. Additionally, as companies begin to grasp the effect of the new adverse event reporting and recordkeeping requirements, dietary supplement manufacturers, packers, distributors, and retailers must completely re-assess their business practices to ensure
procedures are in place at all levels for properly handling and reporting adverse events.
Brace for FDA and FTC monitoring of labeling and marketing practices
Faced with enforcement not only from the FDA, but also from the FTC, companies should also be revisiting product labeling and marketing procedures to ensure proper substantiation is provided for the use of particular health claims on dietary supplement, functional food and nutraceutical products. The FTC has earmarked the dietary supplement industry as an area of concern for the agency. As such, companies should
be re-evaluating their current practices and procedures to avoid a product being taken off the market.
Learn from your peers and benchmark your strategies against industry standards
Understanding what the concerns are of each agency and how your company can establish a viable compliance program are paramount to keeping your product on the market and out of the regulatory crosshairs. Before you finalize your compliance protocol, join us at the American Conference Institute’s 2nd Annual In-House Counsel Forum on Manufacturing, Marketing and Distributing Dietary Supplements, Nutraceuticals and Functional Foods Conference as our expert faculty provides you with
the most up-to-date and efficient strategies for meeting the needs of the current regulatory environment in your industry.
Take advantage of this unique opportunity to hear directly from the FTC
and the National Advertising Division on these issues, while also learning
from your peers. Register now to join us as at this timely event as we
provide you with solutions to the most pressing regulatory and legal
concerns of companies involved with the manufacture, distribution,
packing, or labeling of dietary supplements, nutraceuticals or functional
foods. Also, add value to your attendance by joining us at the
post-conference Master Class on Best Practices for Proving
Substantiation of Claims in Product Marketing, Advertising and