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.
Adverse Drug Reaction (ADR)
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients.
Adverse Drug Reaction:
The detection, assessment, understanding and prevention of ADR are the objectives of the Pharmacovigilance.
ADR in the European Union:
- An ADR is characterized as unintended and noxious responses to a drug and implies a possible causal relationship between the drug and the adverse event. ADR can happen during clinical trials or once the product is on the market.
- ADR should be distinguished from untoward medical occurrence occurring after drug administration and where a causal relationship between the drug and the medical occurrence is excluded (called. Adverse Event).
- Non-serious ADRs should be distinguished from the serious ones which can result in death, life-threatening, hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or congenial anomaly / birth defect.
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