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.
Target product profile (TPP)
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
Target product profile (TPP) in the US
A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. Submission of a TPP is voluntary. Purpose of a TPP is to provide a format for discussions between a sponsor and the FDA that can be used throughout the drug development process, from pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development through post marketing programs to pursue new indications or other substantial changes in labeling.
Target product profile (TPP) in the EU
The Target product profile is referred to as the Quality Target Product Profile (QTPP) in the EU. The quality target product profile forms the basis of design for the development of the product. Considerations for the quality target product profile could include:
- Intended use in clinical setting, route of administration, dosage form, delivery systems;
- Dosage strength(s);
- Container closure system
- Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics (e.g., dissolution,aerodynamic performance) appropriate to the drug product dosage form being developed;
Drug product quality criteria (e.g., sterility, purity, stability and drug release) appropriate for the intended marketed product.
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