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CEMDC, Semmelweis University

CEMDC Cooperative European Medicines Development Course (2017-2019)

Practical Information

Commencing Date :
30 September 2017
Language :
English
Location :
Budapest Hungary


Teaching Methodology :
Blended Learning
Duration :
2 Year(s)


European Fees :
4800 EUR
Scholarship Possibilities :
Yes

Course Contact

CEMDC, Semmelweis University

University Accreditation : Yes

Centre of Excellence

Description

Cooperative European Medicines Development Course (CEMDC) - under discussion www.semmelweis.hu/cemdc The need to provide high-quality and cost-effective medication for mankind living in various countries led to the intensive globalization of the research and manufacturing of medicines. The global need for properly educated professionals with a broad education covering all aspects of medicine development can be primarily provided by highly complex life-long continuous professional training. Unfortunately countries with smaller populations and/or small size pharmaceutical industry cannot provide and maintain this education cost-effectively for a prolonged time. For covering their needs the Cooperative European Medicines Development Course (CEMDC) was organized with the participation of 10 regional universities. (Estonia, Hungary, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Turkey) The PharmaTrain harmonized European course program is used for the teaching. The aim of the course scientifically accredited by PharmaTrain and IFAPP is to train experts who understand the complex process of medicines development from molecule to health care and who can apply this knowledge working in large or small, innovative or generic pharmaceutical companies, small and medium sized enterprises, regulatory agencies as well as in health care and health insurance management. The course material was carefully compiled by academic and industry experts to meet the needs of both the pharmaceutical industry and health care. The training is given in English. Students can apply with a diploma of medicine or pharmacy, MSc or equivalent degrees in natural or life sciences. A satisfactory English knowledge is needed to follow the program. The course is open for students of all nationalities The modules of the course can be visited individually according to the interest of the applicant. Each modules are finished by examination. Employers are encouraged to support this effort to train highly qualified experts for the development of better medicines by giving them some free time and, if possible, financial assistance to follow the course. Instead of providing fellowship the course fee can be reduced upon negotiation in limited cases. Further information For additional information concerning the education plan, participation fee, registration and contact details please consult: http://www.semmelweis.hu/cemdc/about-courses/ Information on the CEMDC and PharmaTrain can be found on the same website: www.semmelweis.hu/cemdc

Covered Areas

Scientific Areas

- PK/PD modelling - Production technologies - Target discovery and lead selection

Therapeutic Areas

Ageing

Methodology

Quality - GMP, GCP, GLP

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered


Modules

Module Title

Type

Duration

Credits

CPD

Module 1a (Int): Introductory Programme, Module 1b: Principles of Discovery of Medicines and Development Planning Core Full time 15.0 ECTS
Module 2: Non-Clinical Testing, Pharmaceutical and Early Clinical Development Core Full time 15.0 ECTS
Module 3: Clinical Development of Medicines: Exploratory and Confirmatory Core Full time 15.0 ECTS
Module 4: Clinical Trials Core Full time 15.0 ECTS
Module 5: Regulatory Affairs; Drug Safety & Pharmacovigilance Core Full time 15.0 ECTS
Module 6: Healthcare Marketplace; Economics of Healthcare, Pharmacoeconomy (added elective section) Core Full time 15.0 ECTS
Module 7: Biological Medical Products and Advanced Elective Full time 15.0 ECTS
Module 8: Follow-On Drugs: Generic, Biosimilar Elective 15.0 ECTS No