Sentences with phrase «in regulatory review processes»

RA professionals are essential to all aspects of the drug development process including preparing, submitting, and monitoring submissions to regulatory agencies, addressing issues raised in the regulatory review process, managing reports, and tracking and other postmarketing functions.

Not exact matches

In a 2012 study, Gerry Angevine and Vanadis Oviedo of the Fraser Institute described «outdated regulatory processes and procedures, unnecessary duplication of federal and provincial government project reviews, and an unwieldy environmental review process.»

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

Kerri Ann - Jones, the State Department official who announced the delay, told reporters in a conference call that the decision to extend the review was made by Deputy Secretary of State Bill Burns in response to listening to the people of Nebraska, who have no state regulatory process for influencing where the pipeline would go.

Finally, the budget proposed changes in the environmental review process for large energy and mining projects would eliminate duplication among jurisdictions and shorten the regulatory timeframe to two years.

«Many investors expected a more lengthy FDA review process of the JCAR015 trial (and potentially other CAR - T programs) and feared that a higher - degree regulatory scrutiny could increase the development risk of CAR T cell,» Leerink Research said in a note co-authored by analysts Michael Schmidt, Ph.D., Jonathan Chang, Ph.D., and Varun Kumar, Ph.D. «While it may take several weeks to reopen all clinical sites of the ROCKET trial, we believe the trial shouldn't be delayed by more than ~ 3 months.»

In it, he provides a tribute to Ron Bannerman, sets out regulatory issues for 2013, discusses the review of the Merger Review Process Guidelines, talks about compliance and enforcement, addresses some consumer issues and discusses ACCC engagement in the regioIn it, he provides a tribute to Ron Bannerman, sets out regulatory issues for 2013, discusses the review of the Merger Review Process Guidelines, talks about compliance and enforcement, addresses some consumer issues and discusses ACCC engagement in the rreview of the Merger Review Process Guidelines, talks about compliance and enforcement, addresses some consumer issues and discusses ACCC engagement in the rReview Process Guidelines, talks about compliance and enforcement, addresses some consumer issues and discusses ACCC engagement in the regioin the region.

Policy Reform participation in the development of industry submissions, responses to government discussion papers, and the regulatory review processes.

«Biopharmaceutical companies support responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research,» said PhRMA Senior Vice President Matt Bennett in a statement.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, the outcome of the review of the continued listing of our common stock on The Nasdaq Stock Market, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

Again, in this letter, OCR has attempted to establish regulatory policy unilaterally by setting forth «guidelines» that have not been subject to the usual process of public comment and interagency review.

To ensure effective preparation and presentation of sound budget estimates for the Department; to foster effective utilization of available resources; to ensure that financial plans are consistentwith approved plans and programs; to establish procedures for the budget phase of the Department's planning and budgeting process; to coordinate program performance planningand reporting throughout the Department, and to ensure preparation of a sound performanceplan for the Department in accordance with the Government Performance and Results Act of1993 (GRPA) and GPRA Modernization Act (GPRAMA) of 2010; to analyze resource and otherimpacts of legislative, regulatory, and budget proposals on departmental programs; to reviewthe budgetary implications of major systems acquisition programs and information technologyinvestments; to periodically conduct formal program reviews; and to assure appropriate stepsare taken on a timely basis to implement newly enacted legislation.

In 2008, Mr. Atamanenko had his motion passed at the Standing Committee on Agriculture and Agri - Food (SCAAF) calling for CFIA officials to be brought before the Committee to present a briefing on the status of their regulatory review process.

In 1998, Channel Islands National Marine Sanctuary (CINMS or Sanctuary) initiated a comprehensive management plan and regulatory review process.

Canada is currently in the process of reviewing environmental acts, regulatory processes, and the National Energy Board (a federal regulatory body), with the intent of restoring lost environmental protections and public trust in major project approvals.

If one thinks a little bit about how this might work in practice, the two critical objectives one has to achieve in designing an effective regulatory framework for enforcing major carbon reductions is to ensure that the framework is implemented strictly according to existing regulatory review processes and procedures; and that it fairly distributes the burden of compliance equally among all carbon emitters — which includes of course most all of America's adult population.

The best ideas resulted in a standardized regulatory compliance review process that eliminated the need for 60 per cent of business reports and, through the use of value - based fees, the department reduced legal spend on employment litigation matters by 30 per cent.

Legal materials to be filed in the Federal Court of Appeal will demonstrate that, among other things, the NEB lacked legal authority to start its review process because of the federal government's failure to first consult Tsleil - Waututh on key decisions about the environmental assessment and regulatory review of the project.

We have advised many investment corporations on a wide variety of compliance and regulatory matters, reviewing policies and procedures as required in the process.

This includes governance reviews and due diligence; promoting high standards of probity and ethics; organisational or functional «health checks»; understanding and ensuring processes and systems are in place to ensure regulatory compliance and minimise fraud; keeping pace with data protection and cyber risk and advising on your duties to be a fair and responsible employer.

Hospitals have always disclosed information but the big shift is that with FIPPA it has created a statutory and regulatory regime for requests, setting out exclusions and a time period for processing requests, a way of calculating costs, and an independent body in the form of the information privacy commissioner reviewing decisions made by hospitals.

Provides support to the policy director and regulatory coordinator by aiding in the facility of the regulatory review process.

Performed key audit reviews to ensure processes and procedures are in compliance with regulatory requirements.

Excel Logistics (Memphis, TN) 7/2004 — 1/2006 Business Analyst • Analyzed business problems, determined cause and nature, and provided innovative solutions • Oversaw implementation of system and process solutions ensuring effective and timely resolution • Identified WMS system modifications, prepared development cost estimates, and determined timeline • Prepared acceptance test plans for WMS systems and assisted in installation and operation • Met internal and external compliance requirements including GxP and SOX for WMS systems • Approved the documentation of key deliverables including plans, protocols, reports, and change controls to ensure contents met business and regulatory requirements • Developed and managed requirement process flows • Reviewed audit reports and responded to findings

Claims Management Duties & Responsibilities Utilize efficient workflow organization to improve departmental efficiencies while ensuring effective client response and diligent analysis of claims, with extensive experience in both commercial and personal lines Provide relevant administration and direction to multi-million dollar staff budgets, quality control, fraud investigations, and complex claims reviews, earning denial authority over high - level claims cases Identify and develop talent among team members with focused training efforts, performance reporting and analyses, and operational efficiency initiatives Deliver continuous assessment of work force, while furnishing oversight and guidance regarding effective service strategies and techniques, loss liability monitoring, and claim litigation assistance Develop and implement the marketing and sales efforts of customer service team while tracking progress versus established internal and external benchmarks, providing disciplinary actions when necessary Construct customer service and claims team through effective staff hiring to aid in efficient operations and execution, delegating important tasks / assigments to line supervisors while providing branch - level guidance Aid in strategic planning and capital budgeting based on improving operating efficiency and reducing service - related production losses, collaborating effectively with senior - level management Maintain a strong working knowledge of important industry topics, company programs and policies, and overall regulatory environment, including state - level responsibility for process changes in casualty / PIP Address important client and staff queries, resolving them in an expedited manner Lead through example with consistent work ethic, attitude and professionalism

A wide ranging review of the Methadone Treatment Protocol [1998], examining the current regulatory processes and oversight arrangements for opiate dependence treatment in Ireland.