New job at the FAGG
Since September 1, 2011, I am working at the FAGG (Dutch abbreviation for Federal Agency for Medicines and Health Products). No, it is not an organisation where only fags work (LOL).
I was looking for some time for this type of job, although I have to admit I would prefer to work at an earlier step in the whole process. I am closing dossiers, checking that all adjustments to be made in the Summary of Product Characteristics (SPC), the Leaflet and Packaging with regard to legal drugs in Belgium are made (and this for the three languages of Belgium: Dutch, French and German). Reading the SPC and Leaflets I notice I still miss science, gaining its knowledge and meeting other scientists. I would prefer to work in the middle of the whole process because at that level people read and decide about the content of the English texts provided by the industry and they meet each other to discuss the process and adjust it when necessary. The text they approve will then be used in all countries of the European Union plus two other European countries as the reference text to be used for the translations. The people working at that level make decisions concerning the correctness of the information in the text: did the industry include all information required to be present in the documents at the correct place and written in such a way that people who need the information understand the content. For instance: the SPC contains information for doctors regarding the (side-)effects of the drug with more scientific background information than the Leaflet that is for the general public; nevertheless in both documents the information need to be complete and correct. But, I like my job and, although it is less intellectual challenging than the other level as I check whether all information present in the English version is present in the translated documents, I can still make a difference. Twice I noticed something that the previous level overlooked: once a manufacturer was forgotten to be mentioned in the Leaflet while the other time an important warning about soya was not mentioned on the package. The persons responsible for the European wide text agreed that these things should be present in the texts so they informed the companies to include the information during the next review.
It is also the first job in my life that doesn't require me to work after the official hours. In the past I took often some work home or I had to work during the weekend to complete a scientific experiment (sometimes they need attention everyday for a certain period so the weekend work was not due to bad planning). Now, when I leave work, I also finish work as I can't work on the dossiers from home.
Another positive thing about the work is that I am in contact with other people regarding the dossiers. Firstly, there are nice colleagues. I also communicate with people from the pharmaceutical industry mainly via email although I had a few phone calls. However, I don't think I will often (if at all) meet people face to face.
Finally, the job allows me to pay the bills.
I was looking of this kind of job for quite some years. But mostly (if not always) the adverts stated companies were looking for Regulatory Affairs Manager with at least two years experience. Now, doing this work I can gain that experience: I will know how the documents look like, the pittfalls, ... . In the meanwhile I can talk with people at work and elsewhere involved in the other stages of the process. So I will gain the experience necessary to apply in future for the possition of Regulatory Affairs Manager in the industry.
A final remark as a sideline regarding the translation into three languages. It is an enormous work and many people are involved in this in all countries therefore giving many people work. However, it makes me believe that we need one world language (for instance Esperanto as a neutral language so no one can say that others only have to learn one language while the rest of the world has to know two languages). Nevertheless, we need the other languages to exist so that cultural differences can continue to exist. So, all people have to learn two languages: their mother language and the world language. But even then, these translations need to be necessary as local people don't need to read documents in the official language in their own area as otherwise those local languages might still disappear. But by including also the world language in the Leaflet, tourists could still understand the Leaflet when visiting a country. (When they decide to live in that country they should be forced to learn the local language out of respect for the people born there or not be allowed to stay as they are not interested in the region where they live; this will prevent tentions arising between people living in a certain area).
I was looking for some time for this type of job, although I have to admit I would prefer to work at an earlier step in the whole process. I am closing dossiers, checking that all adjustments to be made in the Summary of Product Characteristics (SPC), the Leaflet and Packaging with regard to legal drugs in Belgium are made (and this for the three languages of Belgium: Dutch, French and German). Reading the SPC and Leaflets I notice I still miss science, gaining its knowledge and meeting other scientists. I would prefer to work in the middle of the whole process because at that level people read and decide about the content of the English texts provided by the industry and they meet each other to discuss the process and adjust it when necessary. The text they approve will then be used in all countries of the European Union plus two other European countries as the reference text to be used for the translations. The people working at that level make decisions concerning the correctness of the information in the text: did the industry include all information required to be present in the documents at the correct place and written in such a way that people who need the information understand the content. For instance: the SPC contains information for doctors regarding the (side-)effects of the drug with more scientific background information than the Leaflet that is for the general public; nevertheless in both documents the information need to be complete and correct. But, I like my job and, although it is less intellectual challenging than the other level as I check whether all information present in the English version is present in the translated documents, I can still make a difference. Twice I noticed something that the previous level overlooked: once a manufacturer was forgotten to be mentioned in the Leaflet while the other time an important warning about soya was not mentioned on the package. The persons responsible for the European wide text agreed that these things should be present in the texts so they informed the companies to include the information during the next review.
It is also the first job in my life that doesn't require me to work after the official hours. In the past I took often some work home or I had to work during the weekend to complete a scientific experiment (sometimes they need attention everyday for a certain period so the weekend work was not due to bad planning). Now, when I leave work, I also finish work as I can't work on the dossiers from home.
Another positive thing about the work is that I am in contact with other people regarding the dossiers. Firstly, there are nice colleagues. I also communicate with people from the pharmaceutical industry mainly via email although I had a few phone calls. However, I don't think I will often (if at all) meet people face to face.
Finally, the job allows me to pay the bills.
I was looking of this kind of job for quite some years. But mostly (if not always) the adverts stated companies were looking for Regulatory Affairs Manager with at least two years experience. Now, doing this work I can gain that experience: I will know how the documents look like, the pittfalls, ... . In the meanwhile I can talk with people at work and elsewhere involved in the other stages of the process. So I will gain the experience necessary to apply in future for the possition of Regulatory Affairs Manager in the industry.
A final remark as a sideline regarding the translation into three languages. It is an enormous work and many people are involved in this in all countries therefore giving many people work. However, it makes me believe that we need one world language (for instance Esperanto as a neutral language so no one can say that others only have to learn one language while the rest of the world has to know two languages). Nevertheless, we need the other languages to exist so that cultural differences can continue to exist. So, all people have to learn two languages: their mother language and the world language. But even then, these translations need to be necessary as local people don't need to read documents in the official language in their own area as otherwise those local languages might still disappear. But by including also the world language in the Leaflet, tourists could still understand the Leaflet when visiting a country. (When they decide to live in that country they should be forced to learn the local language out of respect for the people born there or not be allowed to stay as they are not interested in the region where they live; this will prevent tentions arising between people living in a certain area).
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