Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Entry of New Oncological Medicinal Products in Colombia Concerning Patient, Government and Industry Interests and How the Quality in the Regulatory Affairs environment Can Be Used as a Tool for Ensuring Access to the Market of Innovative Medicines ***

Carolina Rodriguez Beltran (Abschlußjahr: 2015)

Summary
Language: English
This Master Thesis evaluate how oncological medicinal products are introduced in the market in Colombia, explains the general considerations for the registration of them, including the  relevant laws to be take  into account and includes a description and analysis of  how the approval behavior of oncological medicinal products has been from 2010 to 2014 (establishing a comparison with the decisions taken in two of the most important Health authorities worldwide, EMA from Europa and FDA from the United States).
Other topics influencing indirectly the entry of oncological medicinal products are also analyzed, within Health System, Health Reforms and Free Trade agreements with The United States are included.
As political, economic and scientific aspects are influencing the entry of medicinal products in Colombia, the complexity of the topic is very high and all three aspects are connected, the main goal is to analyze from the scientific point of view, how the quality of the Regulatory Affairs Environment can be used as an effective tool for guaranteeing the access of innovative safe, effective and cost-effective oncological medicinal products to patients without creating unnecessary barriers while considering the fairest solution for the parties involved (Patients, Physicians, government and pharmaceutical industry).
Pages: 75
Annexes: 3, Pages:6