The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value.
Investigational New Drug (IND)
Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
Investigational New Drug
An IND is a request for authorization to administer an investigational drug or biological product to humans with the objective to collect clinical data (e.g. safety, PK, efficacy, …).
IND in the U.S.
The FDA’s primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and in phase 2 and 3 trials, to help assure the quality of the scientific evaluation of the drug’s effectiveness and safety.
For submission to the FDA, the IND application must contain manufacturing information on the product, data from animal pharmacology and toxicology studies with the product, clinical protocols and investigator information.
The central focus of the initial IND submission should be on the general investigational plan and the protocols for specific human studies.
The general principles and content/format of the IND application are dependent upon the applicable legal basis – legal basis is set out in the Code of Federal Regulations (CFR) Title 21 Part 312
Latest Glossary Definitions
Health Economics and Outcomes Research (HEOR) is the most common label given to the function within pharmaceutical and life science companies with the responsibility for generating evidence of value of new interventions for reimbursement agencies
Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.
The plan describes the reference policies and procedures to follow.
Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.
Is responsible for the authorization of medicines / medical devices and for ensuring that
The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.
Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. Tthe redaction should appear as a light blue box with a black 'PPD' label or as a black box with a red 'CCI' label.
In relation to Policy 70, “Personal data” is any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his