Pharmaceutical medicine (E03N9A)

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General

Scientists with biomedical background often end up in the pharmaceutical industry, where they practise various functions. These vary throughout their careers and depend on the department in which they work: preclinical/clinical research and development (R&D), juridical service, medical department, sales, pharmacovigilance, etc... The growing national and international instructions with regards to medicine development and research means that specific expertise is becoming more important. This course wants to provide you with all basic knowledge in order to be put into a professional function within the domain of clinical research, going from molecular biology to the promotion of drugs including the conduction of clinical studies, registration of medicines and medicine surveillance.


Exam form

Oral with written preparation, closed book, final examination during examination period.

After preparing the exam for at least 1h, the student has to give an oral presentation of his answers. During this presentation some additional information can be asked for in order to clarify the answers.


Files

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Professor Jan De Hoon provides the students with 50-60 exam questions out of which 2 will be taken for the actual exam. During earlier years students have solved these questions and made them available. The English version contains unreviewed answers on the exam questions of 2013

Pharmaceutical_medicine_Examquestions_2013

Pharm_Med_questions_2013  

Answers - Pharm Med questions


Exam questions

(Click here to add examquestions.)

Exam questions of '13 - '14

Thursday 19.06.14

DE HOON

  1. Why are elderly a high risk population for the use of drugs? (extra: other precautions in elderly? what kind of drugs can give problems?)
  2. Abstract: study on exposure to anti-epileptics in pregnant women with epilepsy and the effect on the IQ of their children at age 6.
    1. What kind of study design is used? Pros/cons of the deisgn.
    2. Would it be possible to answer the same study with a RCT? (extra: would it be ethical?)
    3. What is your opinion on the outcome?
    4. If this study would be conducted in Belgium, would an approval of EC and/or CA be required?
  3. the figure of the MRSD calculation (the pathway from NOAEL to HED to MRSD). Explain.

SPRIET

  1. Which are the most important procedures available in Europe for the registration of new drugs? Which are the pros and cons of each procedure?
  2. Explain
    1. biosimilars are not interchangeable
    2. PIP
    3. DSMB
    4. CTG repeats the procedure of MA
    5. Nuremberg code


Tuesday 17.06.14

DE HOON

  1. Belgian law concerning experiments on the human person: what is the difference between an experiment and a (clinical) trial? Give an overview of the different kinds of experiments and trials defined within the Belgian law.
  2. Abstract of an article:
    1. What kind of study design is used? Pros/cons of the design.
    2. Would it be possible to answer the same study with a cross-over design?
    3. If this study would be conducted in Belgium, would an approval of EC and/or CA be required?
    4. What would you advice for the future?
  3. Comment a figure about cyclodextrines.

SPRIET

  1. Pharmacovigilance: what is the difference between an adverse event and an adverse drug reaction? (take the definitions in the Belgian legislation into account). When will an adverse event or an adverse drug reaction be considered “serious”?
  2. Short definitions:
    1. Druggability of NCE
    2. Off-label use
    3. MRP
    4. CMA
    5. Nocebo effect

Tuesday 24.06.14

DE HOON

  1. Discuss the principles taken into account when calculating the MRSD for conducting a FIM trial.
  2. Study design article
  3. What is an informed consent, what is procedure followed and what is historical origin of the ICF

SPRIET

  1. discuss briefly:
    1. difference off-label use and unlicensed use
    2. EPAR
    3. PSUR
    4. CMA
    5. active ingredient vs drug
  1. Tabel about categories for reimbursement, give comment (just tell what each category stands for + ex and who decides category of drug)


Wednesday 25.06.14 VM

SPRIET

  1. Provide an overview of the physicochemical aspects which are part of the pre-formulation phase of a drug.
  2. Study design article
  3. Discuss the financial “life cycle” of drugs including the implications for the pharmaceutical company?
  4. sheme of dectrometorphan: explain the metabolism in the first year of life
  5. Explain:
    1. RMP
    2. Lasagna's Law
    3. Declaration of Helsinki
    4. Class 1 drugs
    5. Intrinsic validity

Exam questions of '15 - '16

Explain:

HED PIP Nocebo MRP DSMB

True/False & explain when wrong:

Drugs in category E are not reimbursed Off - label use of drugs is use of drugs in other patient population, other doses, other route of administration without taking into account the contraindications stipulated by the pharmaceutical companies The passive and active transporters are fully matured at 2 months of age Pseudopolymorphisms have same stability, … but their properties in liquid and gas state are same You can ask to someone to stop taking medications before Informed Consent Form is signed, in order to start directly with the test medication when the ICF is signed

Multiple choice:

What is part of the physicochemical characteristics? Who is not protected by Belgian law concerning participating in clinical trial? From which competent authority do you need approval of CTA?

Main question:

Most important differences between ‘small molecules’ and biologicals

Abstract

Text about retrospective cohort study, with hazard ratio’s and confidence intervals

What kind of study? Advantages, disadvantages? Do you need approval Ethical Committee? Why? Why not? Do you need approval competent authority? Why? Why not? Explain hazard ratio / confidence intervals (see if 1 is within interval or not, significant/not significant) Write a conclusion

Figure

Figure about polio vaccination. What does this show? Herd immunity