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WHAT DOES REGULATORY COMPLIANCE MEAN TO YOU?

Not the same as it means to me, I’m sure! 

It depends on where you work and what your responsibilities and interests are.

Because of my personal interest in the licensing of medicinal products, my attention will be on aspects of pharmaceutical compliance, especially pharmaceutical regulatory compliance, that concern gaining approval of .... and maintaining in good order .... a company’s Marketing Authorisations.  As I’ve suggested, we are not going to agree with each other on the meaning of compliance but also we are likely to have different interpretations of the meaning of ‘regulatory’, within the pharmaceutical world. 

You might work in manufacturing, or be involved in documentation to be read and understood by healthcare professionals or patients or you might be focussed on licensing matters or on pharmacovigilance.  All very different specialist areas.

It can go on and on!  You might have a chemistry background or be a pharmacist, engineer, toxicologist, clinician, medical writer or other specialist person and maybe you need to keep up-to-date in your work with current legislation or be aware of and understand the latest official guidelines or the most recent updates to general or individual monographs in various pharmacopoeias.  For each one of us there will be demands for our current professional competences to be maintained, not only because we personally want to give our best service and do things properly but because our employers expect and depend on us to fill our roles to a high standard.

To achieve and then maintain such high performance requires personal effort and motivation but also deserves company support.  Part of this can come from the organisational culture where one works but individually we have a personal responsibility to manage our career development and to take advantage of training opportunities when and where we can. 

What if we are students, or self employed or even unemployed?  Then the challenge is lonelier but if we want to seek out or improve our careers in the pharmaceutical world we may have to try harder, expand our horizons and seek out the less expensive opportunities for training and betterment.  Education is after all a lifetime experience!

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