Occupation:
Clinical Research/Medical Development
Time in Japan:
Two year
Where are you from?
I was born near Volvic (where the mineral water comes from), in the center of France. I'
of mixed origins, but the only culture (and passport) I have is French!
What brought you to Japan?
I had no intention of coming here permanently before I met Yaeko. We met in FranceÑI was
studying Japanese, she was studying French, and we were friends for quite a long time
before we got married in '95. That's when I decided to really learn Japanese. I didn't
have to look for a job; I was contacted by a friend of a friend, met the president of Shin
Nippon Biomedical Laboratories and came here.
What do you do?
Anything related to drug development. My job involves clinical research, registration to
the MHW (Ministry of Health and Welfare) or other regulatory authorities, and many other
things. It's rather complicated. The environment of clinical research in Japan changed two
years ago and most companies and hospitals can't follow the new regulations. What the
industry might do is start clinical research abroad and bring the data back for submission
to the MHW using what's called a bridging process. This is difficult and they need people
who understand the international and Japanese legal environment. We're able to provide
that kind of service.
What research are you doing?
Because we're a service company we do many different things. I've been working recently on
projects concerning medical devices like drug inhalers, and research on drugs for
diabetes, cardiovascular diseases, or asthma.
Do you run into a lot of red tape?
There's not much difference between here and Europe or America. The rules have been
harmonized through the ICH (International Conference on Harmonization). The main
difference I see lies in the way rules are seen in JapanÑit's very difficult to deviate
from them, even if they're not legally binding. A good part of my job is that of legal
adviser. There are different levels of rules. There's the law, then there are ministry
ordinances which have the same value as a law, and finally there are guidelines or
guidance, which are not legally binding. In the US, to a certain extent, you could
disrespect parts of these guidelines or negotiate with the authorities. But in Japan you
have to comply. It's strange when a certain rule has to be followed and you advise a
foreign company, well, it's not exactly a legal rule but that's how Japan does things.
Do you have any advice for people getting jobs in your field in Japan?
I would advise anyone interested in Japan to start by learning Japanese, especially kanji.
It's the only way to really learn about the culture, the people and the country. Forget
everything you heard about Japan before you came because most of the information is wrong
or exaggerated.
What do you like best about Japan?
The food. I love sushi and sashimi. I love the culture, the people. I feel more at home
here than in France. If I had to live outside of Japan permanently, I would need to get
access to good quality Japanese food. I would also need a tatami room and a Japanese
bathroom. What else? Japanese cable or satellite TV.
What do you find frustrating here?
Not much. Maybe that it's very hard to make Japanese deviate from rules; they have a
tendency to respect them. In France, we like to not follow rules. In the US it's more
pragmatic; if the rule is good, you follow it, if not you don't. But you have to define
what's good and what's not.
What's your recipe for a happy life in Japan?
A recipe for a happy life in Japan (or anywhere else): Be flexible and try to see reality
through the eyes of the others. Challenge yourself!
Dr. Jean-David Rafizadeh-Kabe spoke to Maki Nibayashi.
Occupation:
LIFE IN JAPAN: