Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Interactions between Regulatory Affairs and Pharmacovigilance

Lisa Kunzmann (Abschlußjahr: 2015)

Summary
Language: English
Pharmaceutical companies need good functioning operating structures. Within these structures the interaction between the Regulatory Affairs Department and the  pharmacovigilance Department is a key issue for successful and smooth processes in a company and the cooperation has become increasingly important. From the beginning of a product authorisation, the Pharmacovigilance Department as well as the Regulatory Affairs Department are involved in the strategy and planning of a marketing authorisation. During the pre-authorisation phase, the marketing authorisation application phase and during the post-authorisation period, the pharmacovigilance life cycle is complementary to the regulatory life cycle.
Risk Management Plan and Pharmacovigilance System Master File play an important role right from the beginning of the marketing authorisation of the product and require a good timing as well as an effective interaction. CCDS and CCSI are essential for the preparation of all published texts (Summary of Product Characteristics and Patient Information Leaflet). A close collaboration and a proactive planning are necessary for the submission of the PSURs /PBRERs. Variations particularly safety, efficacy, pharmacovigilance changes have to be tracked carefully. Referral procedures may lead to different outcomes e.g. request to update Patient information leaflet/Summary of Product Characteristics, urgent safety restrictions, post-authorisation safety studies and post-authorisation efficacy studies. The responsibility and accountability between Regulatory Affairs and Pharmacovigilance has to be considered. Therefore, an inter-divisional process which clearly addresses the responsibilities has to be defined. Post-authorisation safety studies and post-authorisation efficacy studies require a good cooperation of Regulatory Affairs and Pharmacovigilance but in this case the Clinical Department is also involved which makes the communication as well as the information exchange even more difficult and complex. The renewal is one of the milestones of a marketing authorisation. The benefit risk balance will be re-evaluated which may imply big changes. Time and deadline management is of fundamental importance.
The interface between Regulatory Affairs and Pharmacovigilance is increasingly gaining strategic importance.
Pages: 34