Time travel to IDMP 2016
We are presenting a business situation that might have arisen at your organization with respect to XEVMPD implementation.
This email is to help you understand the importance of starting early for IDMP.
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Jan 11th 2012: Leon Bruster looked up at the huge clock in his office and noted the time. It was just 3 minutes past 11 on this cold Wednesday morning. The icicles had just started forming outside his window pane. However, time was a luxury he didn’t seem to have. The 39 year old head of regulatory at Rova Pharma had his task cut out.
The organization needed to gear up quickly for the upcoming XEVMPD regulation that was going to come into force by July 2012 and the work on this project hadn’t even commenced. He was panicking when his cell phone rang. He picked it up and said ‘hello’. ‘Hello’ said the voice at the other end. He didn’t realize it but Leon was late for his meeting with the CFO Julian Gavin. Julian sounded brief ‘you are late, James and I are waiting’. James Smith was the CEO of Rova Pharma.
Apologizing profusely Leon rushed towards the lift trying to make up for lost time. He arrived at the top floor of the all glass modern art building in about 2 minutes. James and Julian looked like they were engaged in a very grim discussion. He entered the conference room trying to catch his breath before taking his seat at the long wooden table at the centre of the room.
James was the more jovial one of the two. The 52 year old American executive was a recent entrant to Switzerland and thus a little at ease in terms of protocol. He smiled at Leon as he saw him enter the room.
Leon took a few breaths and said ‘Julian we seem to have a big issue with respect to our regulatory implementation for XEVMPD. The issue is that we are totally unprepared for the upcoming XEVMPD implementation deadline on July 1st 2012. Frankly I am worried because I have reviewed our systems and found that we will most likely miss the deadline to implement XEVMPD’.
James looked towards Julian and spoke ‘What could be the potential impact?’ Julian replied ‘we may get a couple of warnings from the regulator, after which they could impose a penalty of upto 10 million Euros, final step could be to tell us to pull our products off the shelf’.
His forehead wrinkling, James looked at Leon and asked ‘What are the key factors that will enable our success in this implementation’? Leon took a deep breath and replied ‘Key factors will be the cross departmental collaboration, buy in from executive management and buy in from individual functional heads. Additionally, questions like who owns the project, who drives outcomes, who will be the key resource in charge of the entire operation will need to be answered. Data readiness, process readiness are key factors with respect to time.’
James sat up in the chair and continued ‘what do we need to do to hit this target Leon’?
Leon replied ‘Considering the timeline, data, process readiness and the consequences to our company should we miss the timeline, I would say that we need an experienced partner who can take over and provide us a turnkey solution’.
James thought for a moment and replied ‘I am authorizing budget on this activity and putting you in charge Leon. You can touch base with Julian on specifics, let us go ahead and select a partner who can deliver this for us. Under no circumstances should we miss this deadline, so let’s go all out and close this project. I am counting on you to deliver this to us Leon. My office has an open door policy, so please do reach out to me in case you need any help’.
This story had a happy ending, thanks to ArisGlobal’s XEVMPD ready software and professional services team which worked overtime to deliver the outcome to Rova Pharma.
The real question is whether your organization would be willing to take a last minute chance on IDMP when it gets implemented in 2016? IDMP is one of the most significant regulations coming up for mainstream adoption in the near future. Effectively utilized, this mandate will not only help your organization meet these regulatory guidelines, but also provide an opportunity to modify certain business processes and bring in improved operational efficiencies. As a company, the consequences of missing a regulatory-safety-manufacturing guideline might be too heavy.
ArisGlobal presents the IDMP Forum 2014, where our experts will share their expertise and insights on IDMP and its effective implementation. Do click the link below to register for the IDMP Forum in a city near you.