Direct link to PMLiVE: PMLiVE
Full text :
Standardization often leads to a “silo management” approach (complaints handling, pharmacovigilance, medical information, training …), each activity being managed more or less independently.
So what can be done? Subsidiaries could have the freedom to adapt processes to local need and facilitate cross-disciplinary compliance management:
– Flexibility – with a degree of freedom provided to the subsidiary will enable greater reactivity to a rapidly changing environment, especially on a regulatory aspect. For example, in the UK, the local branch must consider pharmaceutical regulation, codes of practices but also the provisions of the Bribery Act
– Cross discipline – while compliance requires a global and systemic vision of all critical processes, no process functions independently. To avoid the risk of non-compliance (at the point at which these siloed processes meet), it is important to encourage cross-functional working.
Of course, there will always be a need to standardize operatins mode between subsidiaries and their corporate offices: it makes perfect sense due to the existence of supranational codes (e.g.EFPIA code) and legislation. However, this should be suported by cross-disciplinary working at local affiliate level to ensure that global processes can be shaped to meet local needs.
Advances in computer technologies for process management can support cross-functional working by ensuring that:
– Each subsidiary can adapt corporate processes to meet their own needs and challenges
– Affiliates communicate with each other across a single platform to allow control of all critical processes (HCPs relationships transparency, product risk, product information…), without exception.