Tuesday, 4 September 2012

What about some "Regulatory affairs in the US and EU" - Part X of X

Preface: Yes, we finally arrived to the last station of this long trip through a regulatory affairs course. The tenth and final stop of this very interesting journey of a course written and prepared by Nicholas Wells and made available by the Pharmaceutical International Training.

What is reviewed in the tenth module? Pretty much every regulatory issues that were not covered by the previous modules are seen and put into perspective in the very final part of this course. Different areas are covered, from paediatrics, going to risk management, also combination products and the analysis of two distinct American health related programmes, there is very good information for you to savor and read about. Probably the last bit will completely absorb your attention as the author focuses on the roles and what is expected from a Regulatory Affairs Professional with excellent links for those who want to know more or search further down the line.

What about funny and curious facts revealed in this module? The different opinions on both sides of the Atlantic on what concerns testing drugs in children. Dependent opinion and the lack of trials support both sides of a scale.

International guidelines divided children in 5 classes according to age, and this is how the groups are placed for the trials:
- pre-term new born infants,
- full-term new born infants,
- infants and toddlers,
- children,
- adolescents.

In order to protect the copyright I decided not to include the age ranges so you must look for it yourselves.

What about some awesome quality information? In December 2006 the EU Commission published a regulation on the use of medicines for paediatric use where research into paediatric medicines was stressed out as a topic of major importance.

The fact that the EU grants a two year extension for the orphan medicines researched by a company, even if the results produce nothing at all, thus a nice incentive to help drive research forward.

In the US things started to be adequately shaped earlier (1997-98), regulated by the FDA with sounding cases of success, such as the "Paediatric rule" and the "Paediatric exclusivity".

The guidance documents on EU risk management seem to be imperative in any clinical research laboratories. They can be found in the PDF the author prepared. Overall, it looks like a very solid program sometimes covering a little too pragmatically every in situ little day-to-day issues.

Medicare and Medicaid, for all that goes on in our European heads regarding exactly what we want to make of the huge bill of our National Health Service (everywhere in the European Union), deserves a good reading though. Europe was and still is the best place for any citizen to go sick! However, the European idea that USA abandon the sick and the poor is total bullocks.

Is there anything missing? I was maybe expecting a little more in terms of defining a combination product properly. I must assume that I have, perhaps, missed the point, thus making the author absent of any guilt. Medicare and Medicaid, two North American Health programmes may be now a little outdated after President Obama's recent reviews concerning the health system.

Image taken from Gizmodo, [http://gizmodo.com/drug-testing/], accessed on the 28th of August 2012, last update unknown.

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