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 means the strategy of a regulatory authority referred to in section 15;
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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

  • Source: SEPA One Planet Prosperity, A Regulatory Strategy SEPA’s Regulatory Strategy, One Planet Prosperity, describes the 21st century environmental challenges that Scotland and other countries across the world face, including over-use of natural resources and climate change.

  • In addition to the case study presentations, the workshop shall be used by the End User and by the Contractor to examine in detail the present status of the Regulatory Strategy document, as well as the Action Plan, and to jointly identify the areas where a refinement/improvement is desirable.

  • Strategic Communication as Reputational and Regulatory Strategy A version of this chapter has been published as: Xxxxxx, M., Xxxxx, C.

  • Contractor’s work supports the mission of the Project Integration team of our Business Services organization supporting Project Services, Outer Area End States (OAES), Inner Area End States (IAES), Waste Projects & Operations (WP&O), Soil & Groundwater Operations (S&GO) and Regulatory Strategy & Integration (RS&I) objectives for the planning and execution of waste site remediation and facility deactivation & demolition at the 200, 300 and 100K Areas on the Hanford Site.

  • The above information will be provided in the form of a Regulatory Strategy Report.

  • Xxxxxxxxxx Vice President & Regulatory Strategy Executive Director, Interoperability Strategy Cerner Corporation Cerner Corporation Detailed Responses General Single or Multiple Onramps The trusted exchange framework seeks to establish a single on-ramp to “…access one network, which then becomes a gateway to all other networks…” [TEFCA Draft 2, Page 8).

  • This section of SuperCanada draws heavily from the excellent report by the International Regulatory Strategy Group (IRSG) chaired by former Minister Xxxx Xxxxx and produced with the support of the City of London Corporation, City UK and Xxxxx Lovells.

  • Deliverables • Task report, including: o Proceedings of the workshop, with a summary of the topics discussed and conclusions, including in particular those areas of the current Regulatory Strategy / Action Plan to be refined.

  • Responses to ad-hoc questions related to this topic will be provided to Customer, via email or appropriate report, if not covered in the Regulatory Strategy Report.


More Definitions of Regulatory Strategy

Regulatory Strategy has the meaning set forth in Section 7.1 (Regulatory Responsibility).
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Regulatory Strategy will mean the principal regulatory considerations that are associated with Product development during the Development Program as set forth in Exhibit C and described generally in Section 4.2.
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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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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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Related to Regulatory Strategy

  • Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • 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 to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory entity means any board, commission, agency,

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • 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 with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • 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.