Sentences with phrase «submit safety data»

Not exact matches

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

The national rice institutes plan to submit all safety information to government regulators who will review these data as part of the approval process for Golden Rice before it can be made available to farmers and consumers.

ICRR plans to submit all safety information to government regulators who will review these data as part of the approval process for Golden Rice before it can be made available to farmers and consumers.

By submitting information to us you acknowledge, consent and agree that United Way of the Southern Tier, Inc., may access, read, preserve and disclose the personal information you provide to us as a donor, along with your usage history, submitted messages or data and similar information regarding your use of the website in order to: (a) comply with any applicable law, regulation, legal process, or governmental request; (b) detect, prevent, or otherwise address fraud, security, or technical issues; (c) respond to your requests for customer service; (d) protect the rights, property, or personal safety of United Way of the Southern Tier, Inc., its visitors, or the public, (e) where we sell any or all our business assets; or (f) as otherwise set forth herein.

Under the current system, chemical companies perform safety tests or farm them out to contractors, then submit data for review at the Environmental Protection Agency (EPA) and other agencies.

They had to come up with an idea, submit a proposal, pass a competitive peer review at NASA, raise money, design the equipment, put it together, make sure it passed NASA's rigorous safety precautions, and, of course, collect data on the flight — all work for which they received no course credit.

Of the 21,000 chemicals registered under the law's requirements, only 15 percent have been submitted with health and safety data — and the EPA is nearly powerless to require such data.

The final order will become effective in 90 days, so manufacturers of new devices will need to start submitting data to the FDA about product safety before their products receive clearance to go on the market.

A paper reporting a «rigorous double blind» study — the VIGOR trial — was submitted to NEJM in 1998, got through peer review at one of the most up - tight journals in the world of medicine, and — by way of cherry - picking the data submitted (selecting out some study subjects whose adverse events histories which, if considered, would've significantly affected the safety profile for rofecoxib and revealed something that Merck really didn't want us prescribers to learn about their «blockbuster» product — was published to be touted by Merck's marketing weevils as solid proofs of Vioxx's tolerability, efficacy, and safety.

During this period, generic competitors are not entitled to rely on drug safety or efficacy data submitted to the government by the originator.

Bloomberg News reported one recommendation from the FDA staff administration would require the manufacturers to submit additional safety data to regulators.

For example, the National Highway Traffic Safety Administration (NHTSA) could require companies that want to test autonomous vehicles on public roads to submit more detailed data beyond disengagement reports that some states like California currently require.

KEY DUTIES OF RECRUITMENT CONSULTANT * Managing drivers and being point of contact for resolving issues * Conduct interviews / pre screen and full reference of all drivers * Ensure that all clients and workers comply with health and safety legislation and promptly refer any concerns to the branch manager * Maintaining quality and ISO procedures in line with Standard Operating Procedures to ensure effective, positive quality audit results * Liaising daily with the clients and managing expectations including job requirements, hours of work and rates of pay * Self generate new clients via cold calling and expanding on existing client opportunities * Meet with new and existing clients to account manage and advise of the services available to them * Generate new drivers by way of advertising, social media and networking * Covering out of office calls and demands on a rota requirement * Planning a weekly rota / submitting accurate payroll data / reporting KPI data * Maintaining and increasing daily route allocations — ensuring the customer promise is delivered * Training of drivers in all aspects of the job * Managing claims for damages, insurance and fines * On time reporting of key information to Extra Personnel SKILLS REQUIRED: Recruitment Consultant * Strong Sales and Customer service experience within a fast paced changing environment * Able to communicate at all levels from driver to director * Excellent organisational skills and the ability to prioritise workloads which continually change * Computer literate — outlook, excel and word * Ability to report critical information accurately and to tight deadlines * Ability to use a common sense approach to problem solving * Full UK driving license required BENEFITS As part of our commitment our Recruitment consultant will also receive: * Excellent salary and bonus opportunities * Healthcare Scheme * Pension * Min 23 days holiday plus Bank Holidays rising to a maximum of 29 plus Bank Holidays * Plus an additional days holiday for your Birthday * Continued advancement training