Monday, 16 January 2012

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

PTI's regulatory affairs course I decided to take and which organics I very briefly shared with my audience in this post was designed by author Nicholas Wells (degree in Applied Biology), a managing director of Independent Pharma Consultants in the United Kingdom, known to have extensive experience of international regulatory affairs having made career occupying different senior positions in companies like Pfizer, Novartis and Abbott Laboratories. Clients turn to Nicholas for assistance not only in meeting regulatory requirements, but also in designing strategies for developing and marketing products in the EU and US.

So, finally I put some brave effort in analysing this course and for the coming posts concerning this subject I will be using the same analysis  structure, i.e.:

How useful or good is the course?

I already said I'll be talking about the different modules that compose this course, but essentially to offer you guys a very resumed opinion, the idea I have about PTI's course is that it looks like a very complete course providing very accurate info with an in-depth perspective that, in the end and as a whole, is of a lot of use. The only negative point I'd stress out is that for those opting for this course and looking forward to work in the area it serves only the purpose of gaining and acquiring 1st class theoretical knowledge that will prepare them with all the necessary information of an industry where practical experience is probably what defines it all. This isn't PTI's fault, obviously; people need to understand that as any piece of education this is just education per si. This flaw is not something PTI should be worried about, however this indication is just to help those who come across this course and are trying either to find a job in an area they are not in situ experienced or to just start a career in this field with no former practical experience on regulatory affairs. Apart from that, and in terms of offering a strong insight to those who're already in this area, I believe the course is 10 out of 10! So, this course is what you make of it as you can use it as a tool, but not as an insurance.

What is reviewed in the first module?

The first module basically offers an introduction to the world of regulatory affairs with an overview of the European Union. The inaugural module shares important perspectives on the many varied tasks regulatory affairs professionals are to be involved in.

What about Funny & Curious Facts revealed in this module?

How direct and properly resumed is the way the author give us idea of the uprising of pharmacopoeias around the world by citing an article by R. G. Penn from 1979 (find it here for those who have access to science articles online).  Examples used are, for example, the Egyptian physicians working under financing by public funds basing their practices under written postulates; also some Muslim countries that by the medieval time had established a peculiar office responsible for protecting the public from fraudsters. But the early times of the British regulation on what started as a control to spices and herbs and is now a world of complex rules shows how good the text is.

What about awesome quality information?

I wouldn't expect this author to forgive mentioning the Thalidomide tragedy (see image) of the early 60s, and he didn't!!!

The author also introduces several issues concerning the correct route to gaining approval for products, the chronology that gave rise to pharmacovigilance, and the central aspects of good practice when developing and delivering pharmaceuticals.

I just loved to know there's a Committee on Orphan Medicinal Products reviewing applications made for introducing pharmaceuticals intended to help on rare diseases!

The role of the regulatory affairs professional is very well put and explained, well done! After you readi it you definitely wanna nail that job you've seen advertised somewhere over the internet.

However, a chronological figurative image of how the different bodies and regulations appeared in time and space would accommodate things in our brains in an easier way.

Is anything missing?

Well, probably more diagrams. As the first module is somehow an overall idea of this complex regulatory world, it would help a lot having some initial diagrams accompanying the many bodies involved in this paraphernalia and not only on how to obtain a market authorisation in the European Union. One can obviously find these diagrams further on, but it is easy to get dismayed by the tons of bodies and directives, etc etc etc, that populate the first module.

Picture obtained from Alex Lingham's page "The first appearance of Thalidomide",, last seen on the 16th of January 2012, last update on June 2000. 

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