It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided.
We would recommend a small and focussed piece of work which has the following objectives:
- Understand the issue as it relates to your business.
- Understand the likely impact across your organisation.
- Identify, educate and mobilise an effective cross functional governance team.
- Establish an effective legislative monitoring capability.
- Define an initial “Target Response”.
- Define a plan of action.
- Identify any initiatives that are currently under way and define how they should proceed.
- Understand the high level budgetary implications.
From here, a programme of activity can be managed by the governance team to effectively manage the legislative risk.
How we can help
Our Be4ward team has many years of experience in managing and implementing solutions for serialisation for some of the world’s largest and smallest pharmaceutical companies.
We offer a range of services to assist our clients in the following areas:
- Serialisation education.
- Current situation evaluation.
- Strategy development.
- Governance establishment and membership.
- Legislative interpretation.
- Implementation program design.
- Requirements definition.
- Solution design.
- Supplier selection.
- Project implementation.
- Solution validation support.
As a first step, we would welcome the opportunity to discuss your situation and identify any immediate areas in which we might be of assistance.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help us improve the thinking by adding your comments and share this with others who may have a view.
To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact us directly at [email protected].