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Version
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UNIVERSITÉ DE PARIS-SUD
FACULTÉ DE PHARMACIE
5, Rue J.-B. Clément
92296 CHATENAY-MALABRY CEDEX
France |
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D.E.S.S. of INTERNATIONAL DRUG DEVELOPMENT
and REGISTRATION
Course director: Professeur Charlotte DUPONT
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| Course objectives : |
| This postgraduate Diploma is designed
to enhance the training of the professionals of the drug industry
by an in-depth study of both scientific and regulatory aspects
of drug development and registration worldwide. This distinctive
course focuses not only on the major pharmaceutical markets
such as the European Union (EU), the U.S.A., Canada and Japan,
but also on Africa, Australia, Latin America, S.E. Asia, Switzerland,
the Middle East, Central and Eastern Europe. |
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| Career perspectives : |
- Development and regulatory affairs
divisions in the international pharmaceutical industry,
- French medicines evaluation Agency,
- European Medicines Evaluation Agency (EMEA),
- Contract research organizations.
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| Admission criteria and procedure
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10 to 15 candidates are accepted
each year : pharmacists, doctors of medecine, veterinary surgeons,
M.Sc., or equivalent diploma for foreign students.
Unemployed qualified persons* or salaried employees* may also
apply.
The candidates will be interviewed by a jury made up of faculty
members and representatives of the industry ; an excellent level
in French and in English is required.
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| Academic information : |
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From October to February :
- over 300 hours teaching (lectures and tutorials), 3 to 4
days per week ;
- projects on the development and registration of given products.
From February onwards : a six-month professional training
period.
Courses, given in French and in English, are multidisciplinary
and highly interactive. They are based on authentic case studies,
respecting the confidentiality of data.
All speakers, whether French nationals or foreigners, are
specialists : professionals from the drug industry, university
or agency members.
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| Course outline |
Medicinal products for human and
veterinary use : the pharmaceutical industry.
National and European registrations within the E.U. : legislation,
guidelines, organization.
Registration in the U.S.A., Canada and Japan : legislation and
organization. ICH.
Pharmaceutical documentation : analytical tests and galenic
studies (GMP).
Preclinical documentation : pharmacology, toxicology (GLP),
pharmacokinetics.
Clinical documentation : ethics, GCP, clinical pharmacology,
analysis and reports of clinical trials, statistics and data
processing, special risk populations, case studies of clinical
development.
Drugs with specific development : vaccines, sera, medicinal
products derived from human blood and plasma, medicinal products
from new biotechnology or high technology, radiopharmaceuticals,
veterinary drugs, herbal remedies, medical devices, homoeopathic
medicinal products, orphan drugs, abridged applications...
Constitution of registration dossiers : Summary of product characteristics
(SmPC), experts reports and tabulated study reports (TSR). Record
keeping. National specificities. Other markets (Latin America,
Africa, S.E. Asia, Australia, Switzerland, the Middle East,
Central and Eastern Europe).
Communication skills : preparation of the application dossier,
discussions with the Health Authorities, inspections, post marketing
surveillance. Information leaflets and advertising related to
the marketing authorization.
Economic problems linked with the marketing authorization :
patents, transparency, reimbursement and pricing.
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| Student assessment |
The final mark out of 100 is composed
of the following :
- continuous assessment : presence, communication and intellectual
skills (analysis and judgement) (mark out of 30),
- project formulation for the development and registration of
a given product(mark out of 20),
- professional training period, oral and written report which
may be confidential (mark out of 50).
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* For further information, contact Professeur B. LEGENDRE : Tel : 33.1.46.83.54.57,
responsible for continuing education programs.
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