Masterarbeit

Implementation and Maintenance of additional Risk Minimisation Measures (aRMM) and their interdisciplinary challenges on a local level in a global company ***

Dr. Claudia Benz (2021)

Summary
Language: English
All medicinal products must have an RMP in order to receive approval. The RMP is a tool to prevent and minimize risks of medicinal products and it addresses the safety concerns identified in the clinical studies. Risks can be reduced by using RMM. A distinction is made here between routine RMM - which include SmPC, PL, pack size and prescription status - and additional RMM, which can be applied if rRMM are not sufficient. aRMM includes educational material, controlled distribution system and PPPs. The smooth process of generation, implementation and distribution is necessary to ensure the timely market entry of a new product. Maintenance is important in order to update the aRMMs in accordance with the RMP, so that aRMMs can be displayed at any time in a risk-proportional manner. If by evaluating the effectiveness of the RMM it can be proven that a safety concern has been resolved by the aRMMs and therefore no longer exists, the aRMMs can be adjusted or suspended accordingly.
The implementation of aRMM poses a challenge for a pharmaceutical company, in particular when the product is to come onto the market immediately after the patent expires. The process of generation by local PV and RA and approval by the NCA then often takes place under great time pressure. In order to guarantee a smooth process, the communication and interaction of many departments involved is necessary. At the local level, PV, RA and medical are particularly affected, but also local business intelligence, supply chain, customer service and marketing. Coordination with the global departments is also very important, especially with global PV, who are responsible for providing the draft materials.
Within the scope of this thesis, problems that Mylan has encountered in the past during the implementation and maintenance of aRMMs should be identified and resolved. For this purpose, the problems were compiled under the leadership of PV and RA and productive solutions were developed and implemented with the participation of all departments concerned.
A smooth implementation of aRMM is possible if harmonized educational material is available, the distribution via the ‘common’ channels such as publication on the homepage, distribution by the field service or on request by the customer service takes place and if there is sufficient time. However, the main challenges were no harmonized material or material of inferior quality available and the tight timelines. Harmonized processes at national and European level should be sought, also in order to increase the acceptance of aRMM among HCPs and patients. Within the company, the departments concerned were made aware of launches with aRMM. The process is to be improved through the early provision of draft materials by global PV - if necessary at risk - as well as timely processing by local PV.
Furthermore, the distribution of educational material via digital channels with a focus on mobile scanning via QR code was discussed, which is considered to be a very useful distribution channel to make patients and HCPs aware of aRMMs. Looking ahead, upcoming launches were checked for complex aRMM. A product with a controlled distribution system was identified and therefore the necessity or a burden on HCPs and MAHs was examined.
Concluding, the primary goal should be harmonized processes – at the national but also at the European level, in order to guarantee the same level of drug safety for European patients.
Seiten/Pages: 60
Annexes: 1, Seiten/Pages: 2