Search results with tag "The dossier"
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE …
www.ema.europa.euReference to the current edition of the pharmacopoeia should be included in the dossier for marketing authorisation. When the monograph covers a group of related materials (i.e. polymers), the particular specification chosen for the excipient, should be submitted, together with the rationale for its selection.
SAMPLE TENURE AND PROMOTION DOSSIER Section I: T …
www.valdosta.eduThis sample dossier may be helpful in providing guidance in the preparation of tenure and promotion dossiers. Since faculty members have a variety of experiences and accomplishments, each faculty member’s dossier will be a unique document. Please note that the dossier was divided into six sections and appropriate supporting documents
RESOLUTION AP-CSP (07) 1 Certification of suitability to ...
www.edqm.eu4 1 The assessors examine the dossier submitted and prepare a report in three parts: 2 - Report A or “Confidential report”. This report includes an exhaustive critical assessment of 3 the data provided and is kept in the confidential dossier for certification of suitability. 4 Report A can be made available, on request to any marketing authorisation body, in the
Guideline on Summary of requirements for active …
www.ema.europa.euchemical and herbal active substances in the quality part of the dossier, depending on the described classification. Biological active substances and immunological active substances, as defined in Annex I of the Directive 2001/82/EC and Directive 2001/83/EC, as amended, are excluded from the scope of this Guideline. 1.
The AI Dossier - deloitte.com
www2.deloitte.comThis dossier highlights dozens of the most compelling, business-ready use cases for AI across . six major industries. Each use case features a summary of the key business issues and . opportunities, how AI can help, and the benefits that are likely to be achieved. The dossier also