In pharmacovigilance and in this industry largely, striking a regulatory balance undeniably precedes over anything else. If you are not regulatory compliant, you might be outmoded.

Industry’s competence parameter is not only the quality of the products they are marketing but also how well and how quick they are taking a call for regulatory compliance!

Transition that needs to be addressed…

Industry was just trying to overcome and streamline the gigantic revolution of xEVMPD. As if it was just the beginning of yet another principal leap, Regulator’s announcement of transition to ISO standards became the next breaking news for Industry.

However, a matured Organization would convert it into an opportunity by planning to do this meticulous task of configuring the current system to their advantage. It undoubtedly demands immense diligence and planning for achieving a milestone called ISO-IDMP.

Suggestive Steps to planning:

• Knowing the ISO standards to its core
• Long term planning for each standard to have seamless merger with existing system
• Anticipating the rate-limiters and modulating current strategy to overcome them
  1. Quick Interpretation of the awaited Implementation guide
  2. Outcome (files of extensive data entered into medicinal products, pharmaceutical product, substances etc) derived has to ensure a secure and successful transmission across regulatory gateway
  3. Figuring out the mandatory and the optional i.e., identifiers such as medicinal product identifiers are required and these identifier has to have some data elements defined to generate a unique identifier.
  4. Knowing how much deviation from the current practice is deemed worth and essential to record precise information
• Budget estimate
  1. This seems challenging till the final implementation guide is out for the industry to analyze and conclude how much investment is required for compliance. Alternatively, an estimate can always be ascertained.
• Involving experts to enhance pace of IDMP project
  1. The standards seems comprehensible at first instance but when considering it on a broader perspective for application, an operational know-how of xEVMPD and pharmacovigilance is a necessary requirement.
  2. Subject experts are experienced to scale where problems might occur in this transition and how to manage the task without affecting present workload
• Convenient time to begin
  1. Now is that time to have a comparative checklist of current xEVMPD practices and how different or similar the ISO standards are.
  2. This will be a time saver and an advantage where we can exclusively dedicate time and efforts on what needs to be done for the IDMP expected in mid-2016.

Soon to be aired Webinar on xEVMPD and IDMP: Spanning the similarities and distinctions will highlight more in this area.