Applied Pharmacy 3: Research, Development and Authorization

Data

Official data in SubjectManager for the following academic year: 2026-2027

Topic

During the semester, students will become familiar with the development of the pharmacone into medicine. They will acquire important knowledge related to the official indications of medicinal products and the appropriate legal interpretation of this information. By the categorization and professional interpretation of unwanted effects students will be able to evaluate the safety and efficacy of medicines. Drug authorization, and the marketing and requirements of other product categories (eg medical devices) are also part of the subject. Basic legal knowledge related to clinical research and licensing is also presented.

The subject’s role in the curriculum: The basic task of the subject is to establish and expand the legislative knowledge related to approved medications in order to acquire comprehensive knowledge and practical implications of applied pharmacy practice. The aim of the subject is to attract students' interest to drug research- and development, authorization and pharmacy regulation related topics. Interactive group work of the seminars will improve problem solving and creative thinking skills.

Lectures

• 12. Pharmacovigilance 2. - Fittler András Tamás
• 11. Pharmacovigilance 1. - Fittler András Tamás
• 10. Generic drugs, Equivalencies of drugs, Substitution 2. - Vida Róbert György
• 9. Generic drugs, Equivalencies of drugs, Substitution 1. - Vida Róbert György
• 8. Pharmacogenomics and Personalized Medicine 1 - Vida Róbert György
• 7. Variations of authorization processes, abridged authorization process: orphan drugs, generics - Vida Róbert György
• 6. Drug authorization process, Patent of drugs 1. - Vida Róbert György
• 5. Clinical trial phases 2. - Vida Róbert György
• 4. Pilot study simulation and monitoring clinical trials 2. - Vida Róbert György
• 3. Pilot study simulation and monitoring clinical trials 1. - Vida Róbert György
• 2. Nonclinical studies, preclinical development, Design and methodology in clinical trials - Vida Róbert György
• 1. Research and development of medicines: introduction - Vida Róbert György
• 13. Midterm test - Fittler András Tamás
• 14. Medical Device Clinical Investigation - Ashraf Amir Reza
• 15. Distinction between dietary supplements and medicinal products - Ashraf Amir Reza
• 16. Development and authorization of dietary supplements - Ashraf Amir Reza
• 17. Software as a Medical Device - Ashraf Amir Reza
• 18. Roles of the European Medicines Agency, website content - Fittler András Tamás
• 19. Acceleration of drug development: compassionate use, rolling review - Fittler András Tamás
• 20. Off-label and individual importation of medications - Vida Róbert György
• 21. International Health Organizations, National and International Pharmaceutical Organizations. - Vida Róbert György
• 22. Basics of law 1: The function of norms in society. The general characteristics of legal norms - Szijártó István
• 23. Basics of law 2: The sources of law. - Szijártó István
• 24. Basics of law 2: The sources of law. - Szijártó István
• 25. Functions and institutions of a modern state. - Szijártó István
• 26. Patient Rights - Vida Róbert György
• 27. End of the term consultation - Fittler András Tamás
• 28. End of the term test - Fittler András Tamás

Practices

Seminars

• 4. Pharmacogenomics and Personalized Medicine 2 - Vida Róbert György
• 3. Drug authorization process, Patent of drugs 2. - Vida Róbert György
• 2. Clinical trial phases 1. - Vida Róbert György
• 1. Basics of Clinical trials - Vida Róbert György
• 5. Generic substitution seminar: originals, generics, biosimilars - Vida Róbert György
• 6. Reporting Adevrse Drug Reactions seminar - Vida Róbert György
• 7. Medical devices: authorization and regulation - Ashraf Amir Reza
• 8. Placebo effect in relation with dietary and herbal products - Ashraf Amir Reza
• 9. Roles of the US Food and Drug Administrartion, website content - Fittler András Tamás
• 10. Off-label prescribing in practice - Vida Róbert György
• 11. Basics of law 2: The function of norms in society. The general characteristics of legal norms - Szijártó István
• 12. Courts and judicial remedies. - Szijártó István
• 13. Patient Rights in practice seminar - Vida Róbert György
• 14. End of the term test - Fittler András Tamás

Reading material

Obligatory literature

Literature developed by the Department

List of study aids to acquire curriculum (books, notes, other) and all presentations can be downloaded from MS Teams and/or Neptun MeetStreet.

Notes

Recommended literature

C. Bond (ed.): Evidence-based Pharmacy, Pharmaceutical Press, London, 2002.

A. J. Winfield, R. M. E. Richards (eds.): Pharmaceutical Practice, Churchill Livinstone

C. H. Knowlton, R. P. Penna (eds.): Pharmaceutical Care, ASHSP

M. Stephens (ed.): Hospital Pharmacy, Pharmaceutical Press, London, 2006.

Rosemary R. Berardi, Stefanie P. Ferreri et al.: Handbook of Nonpresciption Drugs, 17th edition, American Pharmacists Association, 2012.

Walker, Roger: Clinical Pharmacy and Therapeutics, 2011.

Edzard Ernst, Simon Singh: Trick or Treatment, W. W. Norton & Company, 2008. Section IV: Nutrition and Nutritional Supplementation, Section XI: Complementary and Alternative Medicine.

Edzard Ernst, Simon Singh: Trick or Treatment? Alternative Medicine on Trial

John P. Griffin, John Posner, Geoffrey R. Barker: The Textbook of Pharmaceutical Medicine, 7th Edition, 2013.

Paul Rutter: Community Pharmacy - Symptoms, Diagnosis and Treatment 4th Edition. Elsevier 2017

Conditions for acceptance of the semester

Acceptance of term/semester:

Regular attendance of classes (maximum 25 % of absence is accepted),

Assignments given in class should be carried out during term-time, and mid-term and end-of-the term test be written/taken. Passing the tests is not obligatory for semester acceptance; however advisable as you will likely have better results and a good recommended grade for the course. There is a retake opportunity only for the end-of-the term test.

Mid-term exams

Mid-term tests: During the semester a mid-term test will be written. In case of unsuccessful or missed test, additional questions will be added to the end-of-the-term test. The number of additional questions may vary regarding the number of unsuccessful or missed mid-term tests. There is no retake opportunity for the unsuccessful or missed mid-term tests.

End-of-the-term test: On the last week of the semester, a test will be written on the whole semester's curriculum. Further additional questions are included in the end-of-the-term test, if the student has not carried out an assignment during the semester. The number of these questions may vary according to the unsuccessful or missed assignments. In case of unsuccessful or missed end-of-the term test, one retake opportunity is granted to make up during the last week of the semester.

Making up for missed classes

Retake opportunity is possible following personal discussion for the end-of-the term test.

Exam topics/questions

Assessment of the student performance is carried out according to a five-grade scale: 100-86,1% -excellent (5); 86-77,1% -good (4); 77-68,1% -satisfactory (3); 68-60,1% -pass (2); and below 60,0% -fail (1) respectively. Final recommended grade for Applied Pharmacy 3. is based upon the completion of the given assignments, the mid-term test and the end-of-the term test. Students with end-of-semester test grade Pass (2) or Fail (1) must take an oral exam in which they present two essays orally. For students whose end-of-semester test is Fail (grade 1), the condition for sitting for the oral exam is to write a successful "Minimum Requirement Test" (MRT) before attempting the oral exam. If the end-of-semester test result is Pass (grade 2) or higher, there is no need to write the MRT.

Examiners

• Ashraf Amir Reza
• Botz Lajos
• Fittler András Tamás
• Vida Róbert György

Instructor / tutor of practices and seminars

• Ashraf Amir Reza
• Fittler András Tamás
• Szijártó István
• Vida Róbert György