POSTGRADUATE EDUCATION IN PHARMACEUTICAL
MEDICINE

 

 

Content of Education

Section 1 / Inventing New Pharmaceuticals In Current Conditions And Context

Inventing new pharmaceuticals

Testing for biological activity of pharmaceuticals

Significance of preclinical data obtained with laboratory animals for humane application

First administration of new substance to humans

Laws and patent protection

Organisation dealing with pharmaceutical development

Managing the pharmaceutical problems within the European community

Pharmaceutical groups, new and old pharmaceuticals

Past, present, and future of pharmaceutical production

Section 2 / Pharmaceutical and Preclinical Research of New Pharmaceuticals

Pre-clinical safety assessment

Strategy and planning development of pharmaceutical form for new pharmaceuticals

Trials of pharmaceutical form suitable for pharmaceuticals under development

Biological accessibility and basic pharmacokinetic parameters

Control mechanisms in development of new pharmaceutical forms

Development of biotechnology

Novel pharmaceutical dosage forms and application methods

Role of state authorities in new pharmaceutical development process

Section 3 / Clinical trials of New Pharmaceuticals

Clinical trial within pharmaceutical company

Clinical trial plan

ICH - GCP

Principles of clinical trial design

Ethical aspects of clinical trial

Data management

Biostatistics in clinical trial

Quality control in clinical trial

Specific aspects of oncology pharmaceuticals, biotechnology products, OTC, psychiatric drugs and pediatric pharmaceuticals

Frauds and misconduct in clinical trial

Clinical trial from the viewpoint of investigators and customers

Summary report writing

Clinical trials, indemnity and the roles of sponsor and investigator

Section 4 / Pharmaceutical Marketing

Introduction of pharmaceuticals into market

Principles and marketing practice

Product manager\\\\\\\\\\\\\\\'s activities

Marketing studies

Information on pharmaceuticals and their presentation

Advertising pharmaceutical products, code of practice / ethical rules for pharmaceutical marketing

Section 5 / International Regulation and Legal Aspects of Clinical trials

Current legal regulations – National, European and differences in European countries

Legal environment for pharmaceutical development in the U.S.A. and Japan

Ethical committees\\\\\\\\\\\\\\\' activity

Informed consent, obtaining informed consent - European position

EMEA - Its structure and relationship with national authorities

Legal and ethical responsibilities of sponsor, investigation and study participants

Registration of new pharmaceuticals

Expert opinions on regulation of medicines and devices in Europe

Section 6 / Pharmaceutical Toxicology

Toxicology of pharmaceuticals

Safety pharmacology

Monitoring pharmaceutical safety in preclinical phase

Genotoxicity of pharmaceuticals

Reproductive toxicity

Pharmacogenomics

Section 7 / Statistics in Clinical trial and Data Management

Clinical trial data analysis, analysis policy

Study power and sample size

Statistic evaluation of various clinical trial designs

Data management

Quality control for clinical trial statistic analysis

Communication between medical department and biostatisticians

Section 8 / Principles of Clinical Pharmacology

Significance of clinical pharmacology in pharmaceutical development

Pharmacodynamics

Pharmacokinetics

Pharmacokinetics modeling

Therapeutic Drug Monitoring (TDM)

Interface between pharmacokinetic professionals and pharmacodynamic professionals

Pharmacotherapy

Special pharmacotherapeutical regimes for liver and kidney failures

Section 9 / Safety of Pharmaceuticals and Pharmacovigilance

History, principles and definitions

Classification of adverse reactions

Mechanisms of adverse effects

Monitoring pharmaceutical safety

European pharmacovigilance system

Data management and signal detection in respect of pharmaceutical safety

Determining causative connections and risk management

Pharmacoepidemiological study – basic principles, methodology

Legal rules and regulations for pharmacovigilance

Pharmaceutical safety and role of media

CIOMS, ICG, and current development of pharmacovigilance regulations

Section 10 / Economic of Pharmaceutical Development and Healthcare

Financial management and corporate finance

Time, project, and human resources management

Principles of health economics

Health-related quality of life

Principles of pharmacoeconomics

Evidence Based Medicine

Costs of clinical trial management

Course Structure

The European Pharma School basic course is two year post-graduate level in pharmaceutical medicine. The course is organised into ten sessions, taking place once every two months, Thursday through to Saturday. The sessions cover the issues of the entire field.

 

Each session is a separate unit with an integrated summary related to the given topic.

Graduates of the basic study will be eligible for the advanced pharmaceutical medicine course. This advanced course deals with certain selected topics in much greater detail than the basic course, and thus, it complies with the requirements for higher level of education and training.

 

The lectures are equally divided between lecturers from the Czech Republic and foreign institutions. Foreign lectures will be simultaneously interpreted into Czech. Each session is coordinated by an expert in the field thus ensuring the quality of the programme.

 

Upon completion of the entire course the student will be awarded a diploma. Students may complete individual sessions or the entire course. After each session, a certificate of completion will be issued. Should a candidate wish to obtain a diploma for the entire basic two-year course, they will need to obtain certificates from all sessions within three years and pass a final written exam. After a successful completion, the candidate will receive a diploma certified by all the institutions involved. The diploma has European-wide validity.

 

After completion of the advanced course, the graduate may also apply to sit an exam with Cardiff University/Faculty of Pharmaceutical Medicine to obtain the British Diploma in Pharmaceutical Medicine. This Diploma is one of the highly recognised certificates and greatly contributes to the candidates future job prospects.

This course is designed for

professionals working in pharmaceutical companies, contract research organisations, academia and regulatory authorities working in areas such as clinical development, registration, pharmacovigilance and marketing,

professionals from clinical departments of pharmaceutical companies that need international certification of their education,

professionals who need to be re-trained to return to an industry position following a break in their career,

graduates of the undergraduate course in pharmaceutical medicine at the 3rd School of Medicine of the Charles University.

Price

Each section:  CZK 45,000

Regular two-year tuition:  CZK 350,000 (a ten-section program)

Dates

Start 2009

 

Three-day session: Thursday through Saturday once every two months (minimum required number of participants is ten).

Total of ten educational sessions during the two-year course.