Regulatory Strategy definition

Regulatory Strategy means, with respect to a Product in a country in the Territory, the strategy for conducting the interactions with Regulatory Authorities needed to develop such Product for such country and to obtain and maintain Regulatory Approval of such Product in such country, including making Regulatory Filings (including INDs, NDAs, and amendments thereto) and developing and implementing risk evaluation and mitigation strategies.
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Regulatory Strategy has the meaning set forth in Section 7.1 (Regulatory Responsibility).
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Regulatory Strategy means a reasonably detailed written plan prepared by E-Z-EM outlining its strategy for achieving Marketing Authorizations in all member states in the Territory mutually agreed by the parties, as amended from time to time by E-Z-EM, including lists of tasks to be accomplished, time lines for completion of various tasks necessary to obtain the Marketing Authorizations, including details of plans to obtain the national licenses.
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Examples of Regulatory Strategy in a sentence

  • Schizer, The Shale Oil and Gas Revolution, Hydraulic Fracturing, and Water Contamination: A Regulatory Strategy, 98 MINN.

  • See APAC Regulatory Strategy for Cultivation Approval dated January 19, 2009.

  • Current tax is the expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted or substantively enacted by the end of the reporting year, and any adjustment to tax payable in respect of previous financial years.

  • Wheeler, Rates & Regulatory Strategy Director, Pricing, Load Analysis & Regulatory Solutions, and was provided to Vote Solar under my supervision.

  • Deshmukh, Rates & Regulatory Strategy Manager, Rate Case Planning & Execution, and was provided to Vote Solar under my supervision.

  • Local hollows or confined areas could lead to more onerous conditions, 53 The Health and Safety Risks and Regulatory Strategy Related to Energy Developments - An expert report by the Health and Safety Executive contributing to the UK Government's Energy Review, 2006 para 122 ff 54 A CO2 concentration of 10% is expected to cause a fatality in a few minutes.

  • Taylor, An International Regulatory Strategy for Global Tobacco Control, 21 YALE J.

  • The City Corporation is working to support a number of representative groups from the financial and professional services sector including TheCityUK, the International Regulatory Strategy Group (IRSG), the European Financial Services Chairmen‟s Advisory Group (EFSCAC), and the leading financial services trade associations.

  • The majority of studies in this category uses the Self Regulatory Strategy Development (SRSD) model of Harris and Graham (1996), in which students are additionally taught self-regulation strategies to manage the writing process, as well as declarative and procedural knowledge about writing.

  • See, for example, AYRES & BRAITHWAITE, supra note 32, at 19–21, 25, 105–06, for a discussion of why some sort of government oversight is required; Neil Gunningham & James Prest, Environmental Audit as a Regulatory Strategy: Prospects and Reform, 15 SYDNEY L.


More Definitions of Regulatory Strategy

Regulatory Strategy means the strategy of a regulatory authority referred to in section 15;
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Regulatory Strategy means the principal regulatory considerations that are associated with Product development during the Development Program as set forth in Exhibit C.
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Regulatory Strategy has the meaning ascribed to such term in Section 3.1.
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Regulatory Strategy. Subpart H Approval for PFIC with Post-Approval Long-Term Outcome Study Seek accelerated approval for PFIC treatment using surrogate endpoint Study planning ongoing; assessing serum bile acids, pruritus and sleep as endpoints following FDA discussions Long-term outcome study to be underway at the time of NDA filing CFR Title 21, Section 314.510: “FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.” Request for pre-Phase 3 FDA meeting planned Q4 2016 A4250
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Regulatory Strategy means the strategy for obtaining a Marketing Authorisation with the aim of ensuring equitable and affordable access to such Product in the Territory at the earliest possible date, consistent with the Access and Implementation Plan.
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Related to Regulatory Strategy

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Strategy means the Department of Education International Risk Management Strategy for Homestays and Short Term Cultural Exchanges developed and implemented under section 171 of the Working With Children (Risk Management and Screening) Act 2000 as in force at any given time.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Regulatory entity means any board, commission, agency,

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • R2000 Strategy means an initiative by the Government of Kenya to improve the maintenance of the country’s Road Network by giving priority to maintenance through network approach, using appropriate technology, labour-based methods, local resources and increased usage of small-scale entrepreneurs.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Regulatory Services Provider means the organization which provides regulatory services to BSEF pursuant to a Regulatory Services Agreement.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.