Sentences with phrase «regarding data submission»

Not exact matches

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.

I have called a tie between Nickey Johnson's submission regarding prosecutorial discretion and its potential for abuse and Stefon Lyons and Arely Lopez's team submission regarding the use of Big Data to predict legal outcomes.

Software patents have trickled through too — a submission from February 2010 saw Apple trying to protect an idea it had regarding «augmented reality maps», shows off how digital mapping data could be overlaid onto real - time video from an iPhone's camera.

Import / Export Compliance Management — Duties & Responsibilities Lead through example with consistent work ethic, attitude, and professionalism, while executing various operational, support and administrative functions and ensuring both efficient organizational communications and on - going process enhancements Develop and maintain all trade compliance policies and operations procedures, updating regularly according to regulatory enhancements initiated by the US government and other related agencies Provide continuous assessment of all execution and resource utilization tasks, while furnishing oversight and guidance regarding process efficiency, delivery and receiving requirements and schedule adherence Perform needs - based and situational assessments of policies and procedures to improve operational efficiency, manage and reduce costs, promote both staff and client satisfaction, and ensure adherence to related quality control standards Utilize talent among team members with focused collaboration and the promotion of a performance - based work environment that leverages individual talents for group benefit Prepare complex licenses and agreements in support of all programs, including temporary / permanent export licenses (DSP 5, 6, 61, 73 and 74), foreign employment licenses, technical assistance agreements and amendments, warehouse distribution agreements and other functions Ensure adherence to all Bureau of Tobacco Firearms and Explosives (BATFE) compliance, including submission of permits (ATF 2, 3, 5, 6 and 9), USG and foreign transfers / variances, record - keeping requirements, destructive device movement and shipping requirements Address key client, personnel, and management queries and resolve them in an expedited manner, promoting sustained operational growth through business retention and the leveraging of available resources Oversee critical functions related to technical data transfers and data management, foreign travel and foreign visitor requests Educate, supervise and lead staff in the execution of all related functions, including the execution of audits and briefings Maintain a strong working knowledge of products, services, techniques and relevant tools, while committing to continued advanced technical education with respect to complex concepts and studies as related to position function Act as a liaison between clients, vendors, support staff and other management partners to facilitate information flow