![]() Product means any deliverable under the Contract, which may include commodities, services, technology or software. Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work. * Data compared to the previous version altered.Please refer to the Summary of Product Characteristics and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs. TEKMIRA shall grant OXFORD, permission to provide the applicable Regulatory Authorities reference access to TEKMIRA’s Investigational Medicinal Product Dossier in a timely manner sufficient to meet OXFORD’s obligations under this Agreement. The Legal Manufacturer or Reseller must supply the testing laboratory with a full duplicate set of the Product Dossier already supplied to WHO in accordance with the requirements of specification clause 7.įurther information on REALIST ORBCEL-C and Plasma-Lyte 148 (placebo control) can be obtained from the Investigational Medicinal Product Dossier (IMPD). There are specific considerations in case of substantial modifications to the Investigational Medicinal Product Dossier (IMPD). WHO Guidance on Variations To A Prequalified Product Dossier, 20075.Ī separate Investigational Medicinal Product Dossier (IMPD) will provide the detail of this process. Ratiopharm Spironolactone does not have any special storage conditions (Please see Appendix 1: 6.4 Special Precautions For Storage). Please refer to the SmPC and Investigational Medicinal Product Dossier (IMPD) for more details about the active and placebo IMPs. ![]() validation in animal models, toxicology, Good Manufacturing Practices (GMP) production, preparation of Investigational Medicinal Product Dossier) and early clinical (up to phase 1) development of already existing lead drug and vaccine candidates. Therefore, the proposed actions should focus on late preclinical (e.g. Examples of Product Dossier in a sentence ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |