Medical Directory for Regulatory Activities Sample Clauses

Medical Directory for Regulatory Activities. (MedDRA) Medical Dictionary for Regulatory Activities [25] is a clinically validated international medical terminology for diagnoses, symptoms, surgeries, and other medical procedures. It is used by regulatory authorities and the regulated biopharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It is translated into several languages and according to the European Union, MedDra is the mandatory tool for coding and transmitting information on product characteristics and side-effects. Since terms of MedDra are mandatory in the regulatory process, it has an important impact. However, it is not a useful tool for automated reasoning since clarification is missing for the relations which hold between the links to upper and lower term. It is not a real hierarchy and it is not a simple vocabulary with some links and connections which carry no semantic content at all. In that way MedDRA can be a useful controlled vocabulary but doesn’t provide semantic relations.
Sample 1
AutoNDA by SimpleDocs

Related to Medical Directory for Regulatory Activities

  • Training and Professional Development C. Maintain written program procedures covering these six (6) core activities. All procedures shall be consistent with the requirements of this Contract.

  • Professional Development Activities Professional development activities are activities initiated by individual faculty members or groups of faculty members and may include attendance at conferences, workshops or seminars which facilitate the following:

  • Medical Director The Contractor shall employ the services of a Medical Director who is a licensed Indiana Health Care Provider (IHCP) provider board certified in family medicine or internal medicine. If the Medical Director is not board certified in family medicine, they shall be supported by a clinical team with experience in pediatrics, behavioral health, adult medicine and obstetrics/gynecology. The Medical Director shall be dedicated full-time to the Contractor’s Indiana Medicaid product lines. The Medical Director shall oversee the development and implementation of the Contractor’s disease management, case management and care management programs; oversee the development of the Contractor’s clinical practice guidelines; review any potential quality of care problems; oversee the Contractor’s clinical management program and programs that address special needs populations; oversee health screenings; serve as the Contractor’s medical professional interface with the Contractor’s primary medical providers (PMPs) and specialty providers; and direct the Quality Management and Utilization Management programs, including, but not limited to, monitoring, corrective actions and other quality management, utilization management or program integrity activities. The Medical Director, in close coordination with other key staff, is responsible for ensuring that the medical management and quality management components of the Contractor’s operations are in compliance with the terms of the Contract. The Medical Director shall work closely with the Pharmacy Director to ensure compliance with pharmacy-related responsibilities set forth in Section 3.4. The Medical Director shall attend all OMPP quality meetings, including the Quality Strategy Committee meetings. If the Medical Director is unable to attend an OMPP quality meeting, the Medical Director shall designate a representative to take his or her place. Notwithstanding the Medical Director ‘s sending of a representative, the Medical Director shall be responsible for knowing and taking appropriate action on all agenda and action items from all OMPP quality meetings.

  • Traditional Medicine Cooperation 1. The aims of Traditional Medicine cooperation will be: (a) to build on existing agreements or arrangements already in place for Traditional Medicine cooperation; and (b) to promote information exchanges on Traditional Medicine between the Parties. 2. In pursuit of the objectives in Article 149 (Objectives), the Parties will encourage and facilitate, as appropriate, the following activities, including, but not limited to: (a) encouraging dialogue on Traditional Medicine policies and promotion of respective Traditional Medicine; (b) raising awareness of active effects of Traditional Medicine; (c) encouraging exchange of experience in conservation and restoration of Traditional Medicine; (d) encouraging exchange of experience on management, research and development for Traditional Medicine; (e) encouraging cooperation in the Traditional Medicine education field, mainly through training programs and means of communication; (f) having a consultation mechanism between the Parties' Traditional Medicine authorities; (g) encouraging cooperation in Traditional Medicine therapeutic services and products manufacturing; and (h) encouraging cooperation in research in the fields of Traditional Medicine in order to contribute in efficacy and safety assessments of natural resources and products used in health care.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Synchronization, Commissioning and Commercial Operation 4.1.1 The Power Producer shall give at least thirty (30) days written notice to the SLDC and GUVNL, of the date on which it intends to synchronize the Power Project to the Grid System.

  • Synchronisation Commissioning and Commercial Operation 8.1 The Developer shall provide at least forty (40) days advanced preliminary written notice and at least twenty (20) days advanced final written notice to ESCOM of the date on which it intends to synchronize the Power Project to the Grid System.

  • Legal and Regulatory Actions Contractor represents and warrants that it is not aware of and has received no notice of any court or governmental agency proceeding, investigation, or other action pending or threatened against Contractor or any of the individuals or entities included in numbered paragraph 1 of these Contract Affirmations within the five (5) calendar years immediately preceding execution of this Contract or the submission of any related Solicitation Response that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. If Contractor is unable to make the preceding representation and warranty, then Contractor instead represents and warrants that it has provided to System Agency a complete, detailed disclosure of any such court or governmental agency proceeding, investigation, or other action that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. In addition, Contractor acknowledges this is a continuing disclosure requirement. Contractor represents and warrants that Contractor shall notify System Agency in writing within five (5) business days of any changes to the representations or warranties in this clause and understands that failure to so timely update System Agency shall constitute breach of contract and may result in immediate contract termination.

Time is Money Join Law Insider Premium to draft better contracts faster.