Masterarbeit
Best practice of worldwide product variations regarding planning, conduct and implementation ***
Dr. Maike Melullis (2015)
Summary
Language: English
The pharmaceutical Industry is a highly regulated environment; in most countries, it is forbidden to sell Medicinal products unless you have obtained a Marketing Authorization by the respective National Competent Authority (NCA). This requirement is not limited to countries with a high regulatory standard, but is basis for pharmaceutical legislation in countries all over the world.
The application for Marketing Authorization includes (besides the necessary administrative information), a regulatory dossier summarizing the obtained information on the quality, efficacy and safety of the medicinal product, which is then assessed and approved by the NCA. Changes made to this dossier have to be notified to the authority via variation application. Therefore, any change made to a product that is marketed worldwide will have an impact on the registrations in all affected countries. Submission of such a change requires careful planning and coordination before, during and after implementation of this change. Regulatory Affairs plays a major role in coordinating the internal and external stakeholders to make sure the implementation of the change is done in compliance with the registered information and legal obligations.
The objective of this Master Thesis is to identify the challenges a worldwide roll-out of variations brings with it during the phases of planning, roll-out and implementation, and to propose strategies and tools on how to deal with them.
Pages: 57