Sentences with phrase «for regulatory strategy»

The fact that the ECJ in the Cremonini case accepted the use of technical standards for legislative purposes without expressing obiter dictum any doubt about its legality, indicated the Court's indirect support for this regulatory strategy.

Jennifer will be responsible for regulatory strategy and execution across Celgene's portfolio and will serve on the company's Executive Committee.

Not exact matches

Important factors that could cause actual results to differ materially from those reflected in such forward - looking statements and that should be considered in evaluating our outlook include, but are not limited to, the following: 1) our ability to continue to grow our business and execute our growth strategy, including the timing, execution, and profitability of new and maturing programs; 2) our ability to perform our obligations under our new and maturing commercial, business aircraft, and military development programs, and the related recurring production; 3) our ability to accurately estimate and manage performance, cost, and revenue under our contracts, including our ability to achieve certain cost reductions with respect to the B787 program; 4) margin pressures and the potential for additional forward losses on new and maturing programs; 5) our ability to accommodate, and the cost of accommodating, announced increases in the build rates of certain aircraft; 6) the effect on aircraft demand and build rates of changing customer preferences for business aircraft, including the effect of global economic conditions on the business aircraft market and expanding conflicts or political unrest in the Middle East or Asia; 7) customer cancellations or deferrals as a result of global economic uncertainty or otherwise; 8) the effect of economic conditions in the industries and markets in which we operate in the U.S. and globally and any changes therein, including fluctuations in foreign currency exchange rates; 9) the success and timely execution of key milestones such as the receipt of necessary regulatory approvals, including our ability to obtain in a timely fashion any required regulatory or other third party approvals for the consummation of our announced acquisition of Asco, and customer adherence to their announced schedules; 10) our ability to successfully negotiate, or re-negotiate, future pricing under our supply agreements with Boeing and our other customers; 11) our ability to enter into profitable supply arrangements with additional customers; 12) the ability of all parties to satisfy their performance requirements under existing supply contracts with our two major customers, Boeing and Airbus, and other customers, and the risk of nonpayment by such customers; 13) any adverse impact on Boeing's and Airbus» production of aircraft resulting from cancellations, deferrals, or reduced orders by their customers or from labor disputes, domestic or international hostilities, or acts of terrorism; 14) any adverse impact on the demand for air travel or our operations from the outbreak of diseases or epidemic or pandemic outbreaks; 15) our ability to avoid or recover from cyber-based or other security attacks, information technology failures, or other disruptions; 16) returns on pension plan assets and the impact of future discount rate changes on pension obligations; 17) our ability to borrow additional funds or refinance debt, including our ability to obtain the debt to finance the purchase price for our announced acquisition of Asco on favorable terms or at all; 18) competition from commercial aerospace original equipment manufacturers and other aerostructures suppliers; 19) the effect of governmental laws, such as U.S. export control laws and U.S. and foreign anti-bribery laws such as the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and environmental laws and agency regulations, both in the U.S. and abroad; 20) the effect of changes in tax law, such as the effect of The Tax Cuts and Jobs Act (the «TCJA») that was enacted on December 22, 2017, and changes to the interpretations of or guidance related thereto, and the Company's ability to accurately calculate and estimate the effect of such changes; 21) any reduction in our credit ratings; 22) our dependence on our suppliers, as well as the cost and availability of raw materials and purchased components; 23) our ability to recruit and retain a critical mass of highly - skilled employees and our relationships with the unions representing many of our employees; 24) spending by the U.S. and other governments on defense; 25) the possibility that our cash flows and our credit facility may not be adequate for our additional capital needs or for payment of interest on, and principal of, our indebtedness; 26) our exposure under our revolving credit facility to higher interest payments should interest rates increase substantially; 27) the effectiveness of any interest rate hedging programs; 28) the effectiveness of our internal control over financial reporting; 29) the outcome or impact of ongoing or future litigation, claims, and regulatory actions; 30) exposure to potential product liability and warranty claims; 31) our ability to effectively assess, manage and integrate acquisitions that we pursue, including our ability to successfully integrate the Asco business and generate synergies and other cost savings; 32) our ability to consummate our announced acquisition of Asco in a timely matter while avoiding any unexpected costs, charges, expenses, adverse changes to business relationships and other business disruptions for ourselves and Asco as a result of the acquisition; 33) our ability to continue selling certain receivables through our supplier financing program; 34) the risks of doing business internationally, including fluctuations in foreign current exchange rates, impositions of tariffs or embargoes, compliance with foreign laws, and domestic and foreign government policies; and 35) our ability to complete the proposed accelerated stock repurchase plan, among other things.

The PGS platform promised genetic risk reports for more than 250 disease at the time — but, after the FDA smackdown, 23andMe was forced to stop marketing the service and pursue a piecemeal strategy of winning regulatory approval of individual tests.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Among the factors that could cause actual results to differ materially are the following: (1) worldwide economic, political, and capital markets conditions and other factors beyond the Company's control, including natural and other disasters or climate change affecting the operations of the Company or its customers and suppliers; (2) the Company's credit ratings and its cost of capital; (3) competitive conditions and customer preferences; (4) foreign currency exchange rates and fluctuations in those rates; (5) the timing and market acceptance of new product offerings; (6) the availability and cost of purchased components, compounds, raw materials and energy (including oil and natural gas and their derivatives) due to shortages, increased demand or supply interruptions (including those caused by natural and other disasters and other events); (7) the impact of acquisitions, strategic alliances, divestitures, and other unusual events resulting from portfolio management actions and other evolving business strategies, and possible organizational restructuring; (8) generating fewer productivity improvements than estimated; (9) unanticipated problems or delays with the phased implementation of a global enterprise resource planning (ERP) system, or security breaches and other disruptions to the Company's information technology infrastructure; (10) financial market risks that may affect the Company's funding obligations under defined benefit pension and postretirement plans; and (11) legal proceedings, including significant developments that could occur in the legal and regulatory proceedings described in the Company's Annual Report on Form 10 - K for the year ended Dec. 31, 2017, and any subsequent quarterly reports on Form 10 - Q (the «Reports»).

Most recently she served as director of external affairs and communications for Spectra Energy's Canadian LNG business, responsible for development of natural gas infrastructure investment opportunities related to liquefied natural gas in Western Canada, as well as development of strategies to address market, regulatory, and stakeholder risks associated with potential LNG projects.

Forward - looking statements may include, among others, statements concerning our projected adjusted income (loss) from operations outlook for 2018, on both a consolidated and segment basis; projected total revenue growth and global medical customer growth, each over year end 2017; projected growth beyond 2018; projected medical care and operating expense ratios and medical cost trends; our projected consolidated adjusted tax rate; future financial or operating performance, including our ability to deliver personalized and innovative solutions for our customers and clients; future growth, business strategy, strategic or operational initiatives; economic, regulatory or competitive environments, particularly with respect to the pace and extent of change in these areas; financing or capital deployment plans and amounts available for future deployment; our prospects for growth in the coming years; the proposed merger (the «Merger») with Express Scripts Holding Company («Express Scripts») and other statements regarding Cigna's future beliefs, expectations, plans, intentions, financial condition or performance.

DOL's rule is the latest regulatory threat to the independent BD «legacy business model,» says Matthew Lynch, managing partner of Strategy and Resources LLC, and for BDs with a significant amount of commission business that involves ERISA accounts, «something has to change» in terms of compliance and coming to terms with BICE.

As the Director for Bitcoin Strategies, Brad is helping to design an appropriate regulatory framework around Bitcoin adoption and use for Victoria Global.

The only exit strategy, if you can call it that, for government is a strong commitment to carbon pricing or regulatory requirements for CCS.

We urge the Government to provide further detail on its proposals for the UK's future trading and regulatory relationship with the EU, and to iron out its initiatives to narrow the skills gap and enhance business productivity through the Industrial Strategy.

Other economic policies include reducing the regulatory burden for small businesses and northern development; a new $ 75 million venture capital fund to help businesses commercialize new technology developments; a $ 900 million Strategic Aerospace and Defence Initiative and a $ 250 million Automotive Innovation Fund to support these industrial sectors; a $ 1 billion Community Development Trust to support communities and workers in struggling industries; a commitment to reduce inter-provincial trade barriers by 2010; pursuing new trade agreements with emerging markets; as well as a reorganization of federal regional development strategies.

«Whenever you have regulatory constraints and it closes down a market, it provides opportunities for those who fall outside the regulatory constraints,» said Alan White, professor of investment strategy at University of Toronto's Rotman School of Management.

She will receive $ 14 million in severance pay and a $ 7.4 million bonus for 2004, according to terms of the agreement submitted Friday in regulatory filings — even though Wednesday the board singled out her failure to accelerate the company's strategy, the newspaper reported.

Examples of these risks, uncertainties and other factors include, but are not limited to the impact of: adverse general economic and related factors, such as fluctuating or increasing levels of unemployment, underemployment and the volatility of fuel prices, declines in the securities and real estate markets, and perceptions of these conditions that decrease the level of disposable income of consumers or consumer confidence; adverse events impacting the security of travel, such as terrorist acts, armed conflict and threats thereof, acts of piracy, and other international events; the risks and increased costs associated with operating internationally; our expansion into and investments in new markets; breaches in data security or other disturbances to our information technology and other networks; the spread of epidemics and viral outbreaks; adverse incidents involving cruise ships; changes in fuel prices and / or other cruise operating costs; any impairment of our tradenames or goodwill; our hedging strategies; our inability to obtain adequate insurance coverage; our substantial indebtedness, including the ability to raise additional capital to fund our operations, and to generate the necessary amount of cash to service our existing debt; restrictions in the agreements governing our indebtedness that limit our flexibility in operating our business; the significant portion of our assets pledged as collateral under our existing debt agreements and the ability of our creditors to accelerate the repayment of our indebtedness; volatility and disruptions in the global credit and financial markets, which may adversely affect our ability to borrow and could increase our counterparty credit risks, including those under our credit facilities, derivatives, contingent obligations, insurance contracts and new ship progress payment guarantees; fluctuations in foreign currency exchange rates; overcapacity in key markets or globally; our inability to recruit or retain qualified personnel or the loss of key personnel; future changes relating to how external distribution channels sell and market our cruises; our reliance on third parties to provide hotel management services to certain ships and certain other services; delays in our shipbuilding program and ship repairs, maintenance and refurbishments; future increases in the price of, or major changes or reduction in, commercial airline services; seasonal variations in passenger fare rates and occupancy levels at different times of the year; our ability to keep pace with developments in technology; amendments to our collective bargaining agreements for crew members and other employee relation issues; the continued availability of attractive port destinations; pending or threatened litigation, investigations and enforcement actions; changes involving the tax and environmental regulatory regimes in which we operate; and other factors set forth under «Risk Factors» in our most recently filed Annual Report on Form 10 - K and subsequent filings by the Company with the Securities and Exchange Commission.

As senior vice president of government affairs for ABA, McGreevy is responsible for shaping advocacy strategies for the beverage industry and representing the interests of ABA members before lawmakers and regulatory bodies.

As senior vice president for political affairs, Bailey - Chapman will shape advocacy strategies for the beverage industry and represent the interests of ABA members before lawmakers and regulatory bodies nationwide.

The head of the Food and Drug Administration last week affirmed the importance of several of IDFA's regulatory priorities when he announced a multi-year nutrition strategy plan for the agency.

For example, Clem Yates, sourcing and supply director of Off - Piste Wines, is going to talk about private label & bulk strategies for importers and distributors and how to meet the store brand challenge, in private label & channel conflict; Andrew Shaw, Group Wine Buying Director, Conviviality PLC will talk about bottled in market strategy and how suppliers can partner with Conviviality; Florian Ceschi, Director of Ciatti Europe will give a detailed statistical analysis of the current bulk market and will identify opportunities where producers and negociants can take advantage of; David Richardson, Regulatory & Commercial Affairs Director, The Wine and Spirit Trade Association (WSTA) will speak about regulatory issues specific to bulk products compared to cased gooFor example, Clem Yates, sourcing and supply director of Off - Piste Wines, is going to talk about private label & bulk strategies for importers and distributors and how to meet the store brand challenge, in private label & channel conflict; Andrew Shaw, Group Wine Buying Director, Conviviality PLC will talk about bottled in market strategy and how suppliers can partner with Conviviality; Florian Ceschi, Director of Ciatti Europe will give a detailed statistical analysis of the current bulk market and will identify opportunities where producers and negociants can take advantage of; David Richardson, Regulatory & Commercial Affairs Director, The Wine and Spirit Trade Association (WSTA) will speak about regulatory issues specific to bulk products compared to cased goofor importers and distributors and how to meet the store brand challenge, in private label & channel conflict; Andrew Shaw, Group Wine Buying Director, Conviviality PLC will talk about bottled in market strategy and how suppliers can partner with Conviviality; Florian Ceschi, Director of Ciatti Europe will give a detailed statistical analysis of the current bulk market and will identify opportunities where producers and negociants can take advantage of; David Richardson, Regulatory & Commercial Affairs Director, The Wine and Spirit Trade Association (WSTA) will speak about regulatory issues specific to bulk products compared to cased goods.

Canada is currently in a regulatory evaluation phase to identify strategies for reducing and eliminating acrylamide formation, while the U.S. Center for Food Safety and Applied Nutrition published a draft guidance document for manufacturers in November 2013.

The Commission has failed to tackle the issue of FUF advertising and now has no credible strategy for curbing the growth in this new market — except dialogue with the industry about voluntary self - regulatory options.

The Commission has provided no credible strategy for protecting child health and curbing the growth in this new category of products — except dialogue with the industry about voluntary self - regulatory options.

For the Republic of Ireland, adopting a «soft border strategy» means holding fast to its insistence on regulatory alignment even at the cost of a long - term trade deal between the Republic (and the rest of the EU) and the UK.

This has been confirmed time and again: most recently by Europe's preeminent group of regulatory assessors at the European Medicines Agency Committee for Medicinal Products for Veterinary Use (CVMP), which says in its draft strategy on antimicrobials that: «it is recognized that the biggest driver of AMR in people is the use of antimicrobials in humans or human health.»

The Reforming the Energy Vision is Cuomo's strategy designed to «to build a clean, resilient and affordable energy system for all New Yorkers» with statewide initiatives and regulatory reforms, according to the release.

ABI Fraud Conference, in Partnership with Ordnance Survey, will provide an opportunity for senior fraud practitioners to come together and discuss key insurance fraud issues including government anti-fraud strategy, regulatory changes, and the perception of insurance fraud as a victimless crime.

pants through the NY State Model Solar Ordinance and review strategies and best practices for developing a clear, comprehensive, and enforceable solar regulatory framework.

The second part of the workshop walked participants through the NY State Model Solar Ordinance and review strategies and best practices for developing a clear, comprehensive, and enforceable solar regulatory framework.

He said that the most exciting arenas of immunology today include new strategies for vaccines and studies of regulatory T lymphocytes and the innate immune response, which is essentially the most general form of attacking pathogens.

The advances even point to strategies for exploiting these regulatory elements to treat disease, by switching off disease genes and turning up the activity of healthy ones.

«As a powerful model system for studying adult stem cells, Drosophila female GSCs have revealed many novel regulatory strategies which have been later confirmed to be generally true,» adds Su Wang, a co-first author of the paper and also a graduate student in Department of Anatomy and Cell Biology at University of Kansas Medical Center.

«Furthermore, this strategy may be beneficial for other pathological settings in which elevated numbers of regulatory T cells are desirable, such as autoimmune diseases and solid organ transplantation,» Beilhack says.

The authors noted: «From this perspective, by strengthening tumor - associated immune responses, targeting [regulatory T cell] autophagy could act in synergy with strategies that block autophagy in tumor cells for added benefits in cancer therapy.»

Our collaborative approach and deep scientific and regulatory understanding of each molecule type helps us shape the best strategy for bringing a novel therapy to market and design custom studies and programs that reduce risk and accelerate timelines.

A novel strategy for using the CRISPR system to better understand regulatory elements of the genome has been demonstrated by researchers

Dr. Gringeri was responsible for the planning and execution of all major aspects of corporate strategy and operations, including regulatory affairs and doubling the size of the company pipeline.

Ultimately, a better molecular - level understanding of the regulatory mechanisms that control ALC1 activity may in the long term open up new horizons for therapeutic intervention strategies», Deindl says.

Adams is responsible for the full spectrum of Infinity's drug discovery, preclinical, and clinical development strategy, and regulatory affairs activities.

As a result, repurposing — applying drugs or compounds developed for one condition for the treatment of another — has become an attractive strategy, offering the potential for relatively rapid regulatory approvals and lower costs.

This is a clever strategy for beginning to tease out regulatory variation in Mendelian disorders, and may help open the door for even more discoveries.

This study provides a genome editing - based multiplex strategy for direct functional interrogation of RNA cis - regulatory elements in a native cellular environment.

• Around 1,000 more teachers • $ 6.1 million over three years to support an updated anti-bullying strategy and resources for teachers, students and parents • Funding of $ 88 million in 2017 - 18 as part of the $ 224 million for teacher professional development through the Quality Teaching, Successful Students initiative • Funding of $ 50 million in 2017 - 18 on student counselling and wellbeing services as part of the $ 167 million Supported Students, Successful Students program • $ 149 million on education standards for provision of services related to school curriculum assessment, teaching and regulatory standards in NSW schools

No one knows the ideal political strategy or regulatory scheme, so having a variety of different approaches allows us to learn about how these different methods for expanding choice are doing.

For all their differences, they shared a surprisingly common approach to school reform: Both preferred a regulatory strategy.

-- Perhaps it's simply misunderstood — investors may simply not grasp a company's management / business / strategy have changed in a major way, or they under / over-estimate the potential impact (for example) of some litigation or regulatory action.

As our survey reports, on all fronts investors are reassessing their short - term fixed income investment portfolios, looking for the strategies and solutions that can best help them navigate the changing global market and regulatory environments.

Some of the policies examined include the B.C. carbon tax, Ontario's Green Energy and Economy Act and phase - out of coal - fired power, Quebec's and Nova Scotia's regulatory cap on emissions, public transit strategies in Ontario, and federal fuel - efficiency standards for cars.

Matt McCaffree is Senior Director of Regulatory Strategy at Comverge, Inc., where he sets the regulatory agenda for one of the country's leading demand response providers.

ALEC also offers a document titled «EPA's Regulatory Train Wreck: Strategies for State Legislators» that «outlines best practices for state legislators (including following the many states that are considering resolutions in 2011 to call for Congress to slow and stop this regulatory onslaught [by the EPA]-RRB-.»