|
|
| |
Version
: FR | GB |
Le DESS
de Développement et d'Enregistrement International
des Médicaments de Châtenay-Malabry
(PARIS XI) est une formation unique.
Là où d'autres n'enseignent que la réglementation,
ce DESS a su parfaitement intégrer l'aspect technique
et scientifique propre à l'univers des affaires
réglementaires pharmaceutiques, tout en tenant
compte des spécificités de chaque région
du monde.
|
| |
|
UNIVERSITÉ
DE PARIS-SUD
FACULTÉ DE PHARMACIE
5, Rue J.-B. Clément
92296 CHATENAY-MALABRY CEDEX
France |
 |
|
| TEACHERS |
|
| Professeur Pierre BAC
(pierre.bac@cep.u-psud.fr)
Docteur Michèle GERMAN (michele.german@cep.u-psud.fr)
|
| |
|
| |
|
| CONTACT: SECRETARY
OF THE COLLEGE OF PHARMACY |
|
| Madame Caroline PARANT (caroline.parant@cepadm.u-psud.fr)
|
| |
|
| ADMISSION REQUIREMENTS |
| This Master is opened
to Pharmacy, Medicine, Veterinary and Scientific students
who validated a M1 level or an equivalent. 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. |
| |
|
| |
|
| |
|
| SUBSCRIPTION FORMALITIES |
|
| Download the formulary on
http://www.u-psud.fr (university website)
Faculté de Pharmacie
Service de Scolarité
5, rue Jean-Baptiste Clément
92 296 Châtenay-Malabry
|
| |
|
| 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.
|
| |
| |
| |
| CAREERS PERSPECTIVES |
Pharmaceutical companies,
national and international drug agencies, consulting offices
and contract research organizations in the following sectors:
- Non-clinical and clinical drug development
- Pharmacovigilance
-Regulatory affairs: MA application, regulatory and concurrence
update, extension of indications, MA renewal, clinical
trial application, variations, SPCs/PILs updates, medical
and pharmaceutical information…
|
| |
| MASTER ORGANIZATION |
- 6 credits to validate.
- French or English lectures and conferences led by Pharmaceutical
Industry or Drug Agencies professional. Personal or Team
projects.
- A 6-month training period (France, European Union, Switzerland,
Canada, United-States, Australia) validated by a report
and an oral presentation about the missions carried out
during the training.
- For Pharmacy students, a report on a drug development
or registration point could lead to the exercise theses
(PhD).
- The teachers help the students for:
- Their training research and their choices: a list of
the pharmaceutical companies in France and abroad which
are engaged in the reception of the students is available;
Resume and motivation letters redaction; interview preparation
and organization of interviews in the college of Pharmacy.
- Their professional insertion after the diploma, in partnership
with three consulting offices.
|
| |
| EUROPEAN CREDITS (
A TOTAL OF 60 CREDITS) |
- Scientific content of the
MA dossier…....……………………………………………………………10
credits
- European drug development and registration………………………………………………………..5
credits
- International drug development and registration……..…………………………........……………..5
credits
- Biotechnology products development and registration……………….……..……………………...3
credits
- MA activities, economic aspects...………………………………………………………………….…3
credits
-Drug development project……………………………………………………………………………...4
credits
- A 6-month training period at minima………………….………………………………………...30
credits
|
| |
|
|
|
|
