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- Regulatory Affairs
- Bioequivalence
- Evidence Based Outcomes
- Pharmacoeconomics
- Clinical Pharmacology
We offer basic courses for up to 5 participants
in all mentioned areas. During the courses the scientific
basis in each area is presented together with the
legal (especially Regulatory Affairs) framework. The legal background is based
on EU and Polish law. In addition to legal framework the common practices are
presented.
We have also good experience with the organization
of big conferences dealing with the above topics.
We have organized several such conferences, e.g.:
- First Leon Ko¼miński Academy. Conference on
Pharmacoeconomics and Health Technology Assessment,
Warsaw, Nov. 29-30, 2002.
- Rejestracja Leków w Polsce po 1 Maja 2004,
Warsaw, Feb 23,2004.
Our service include:teaching the basics
of clinical experimentations (statistics, ethics,
GCP and ICH) including bioequivalence (how to plan
successful study ?), principles of EBM, pharmacoeconomics
- basics, teaching the principles of clinical trials.
Our experience: two big conferences, teaching
pharmacokinetics and teaching and introduction to clinical
aspects of new pharmaceutical law (in effect from Nov.1)
and new EMEA guidelines. |
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From
plans to goals and value. |
The ideas mentioned above are extremely important
at the stage of planning. Once the project is well-planned
the chances for success are high. Success means value:
excellent plan is a success as well as each step,
even the smallest one, on the way to the big goal.
We think meticulously on each move - this is how
we build and how we consider value.
Achieving a goal is of paramount importance. It
does not matter whether you are starting your business
or "you are old" in the business and you know how
to do it. When you are starting you need a success
to survive, when you are "old" you cannot afford
a failure. Throughout the life of your medicinal
product, especially at its delivery, and to help
its survival our service is of real value. Try us
to know how profitable could be our assistance. |
| Expert
voice |
Expert Voice
During last two months there is a growing pressure
on the budget to increase the GNP share for the
health care. All the parties present at several
meetings, e.g. "Koalicja dla Zdrowia", "Reimbursement", "Rynek
Zdrowia" and others argue that this share should
be increased by 2%. Ministry declares (this is
not a new declaration, some may thing about déja
vu phenomenon)... read
more |
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