{"id":44,"date":"2024-12-17T09:28:46","date_gmt":"2024-12-17T08:28:46","guid":{"rendered":"https:\/\/semmelweis.hu\/pharmaster\/?page_id=44"},"modified":"2026-08-24T09:41:47","modified_gmt":"2026-08-24T07:41:47","slug":"studycontent","status":"publish","type":"page","link":"https:\/\/semmelweis.hu\/pharmamaster\/studycontent\/","title":{"rendered":"Study content"},"content":{"rendered":"
\n
Our curriculum is designed to address all critical aspects of the industry and equip you to take on a variety of roles and leadership positions.\u00a0<\/h6>\n
These subjects provide a comprehensive knowledge of the most important areas of the pharmaceutical and healthcare industry. The Pharma Masterclass programme not only opens up new career opportunities for you, but also gives you a competitive edge in the job market.<\/h6>\n<\/div>\n
Study Content:<\/h5>\n
Business Development, Intellectual Property Protection, Life-cycle management<\/a><\/p>\n
\n

Semmelweis University, Faculty of Medicine
\n<\/strong><\/span>Pharmaceutical Innovation and Business Administration Master of Science<\/span><\/p>\n

Name of the host institution (and any contributing institution): <\/span><\/strong>Department of Pharmacology and Pharmacotherapy<\/span><\/p>\n

Name of subject:<\/strong> Business Development, Intellectual Property Protection, Life-cycle management<\/span><\/p>\n

English:<\/strong> Business Development, Intellectual Property Protection, Life-cycle management<\/span><\/p>\n

in German:<\/strong> not applicable<\/span><\/p>\n

Credit value:<\/strong> 5<\/span><\/p>\n

Semester:<\/strong> 2025\/2026 2nd Semester<\/span><\/p>\n\n\n\n\n
Hours per semester<\/strong><\/span><\/td>\nLecture<\/strong><\/span><\/td>\nCourse work<\/strong><\/span><\/td>\nSeminar<\/strong><\/span><\/td>\n<\/tr>\n
150<\/span><\/td>\n25<\/span><\/td>\n125<\/span><\/td>\n–<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n
Hours per week<\/strong><\/span><\/td>\nLecture<\/strong><\/span><\/td>\nPractical lesson<\/strong><\/span><\/td>\nSeminar<\/strong><\/span><\/td>\n<\/tr>\n
Course blocks tailored to the students\u2019 employment obligations on Fridays and Saturdays<\/span><\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Type of course:<\/span><\/strong><\/p>\n

compulsory<\/span><\/p>\n

Academic year:<\/span><\/strong><\/p>\n

2025\/2026<\/span><\/p>\n

Language of instruction (for optional and elective subjects):<\/span><\/strong><\/p>\n

English<\/span><\/p>\n

Course code:<\/span><\/strong><\/p>\n

(in the case of a new course, to be completed by the Dean\u2019s Office, following approval)<\/span><\/p>\n

Course coordinator name:<\/strong><\/span><\/p>\n

Prof. Dr. P\u00e9ter Ferdinandy<\/span><\/p>\n

Course coordinator location of work, telephone availability:<\/strong><\/span><\/p>\n

Semmelweis University Department of Pharmacology and Pharmacotherapy, 1089 Budapest, Nagyv\u00e1rad t\u00e9r 4. Tel: +36-1-2104416, e-mail: ferdinandy.peter@semmelweis.hu<\/span><\/p>\n

Course coordinator position:<\/strong><\/span><\/p>\n

Head of Department, full professor<\/span><\/p>\n

Course coordinator Date and number of habilitation:<\/span><\/strong><\/p>\n

June 2 2001., 26\/2001 Hab.<\/span><\/p>\n

Objective of instruction and its place in the curriculum:<\/span><\/strong><\/p>\n

This course introduces participants to the fundamentals of intellectual property protection, business <\/span>development, strategic planning, and product life-cycle management in the pharmaceutical and <\/span>biotech industry. Learners will gain practical skills to analyze markets, evaluate opportunities, and <\/span>develop actionable business plans for new and existing products. The course also covers strategies for<\/span>
\npartnerships, licensing, and collaborations, as well as approaches to maximize product value and <\/span>navigate challenges throughout its life cycle.<\/span><\/p>\n

Method of instruction (lecture, group work, practical lesson, etc.):<\/span><\/strong><\/p>\n

Lecture, course- -work<\/span><\/p>\n

Competencies acquired through completion of course:<\/span><\/strong><\/p>\n

\u2026\u2026.<\/span><\/p>\n

Course outcome (names and codes of related subjects):<\/span><\/strong><\/p>\n

\u2026\u2026.<\/span><\/p>\n

Prerequisites for course registration and completion: (CODE):<\/span><\/strong><\/p>\n

None<\/span><\/p>\n

In the case of multi-semester courses, position on the possibility of and <\/span>conditions for concurrent registration:<\/span><\/strong><\/p>\n

None<\/span><\/p>\n

The number of students required to start the course (minimum, maximum), <\/span>student selection method:<\/span><\/strong><\/p>\n

All students admitted to the MSc course<\/span><\/p>\n

Detailed course syllabus (if the course can be divided into modules, please <\/span>indicate):<\/span><\/strong><\/p>\n

(Theoretical and practical instruction must be broken down into hours <\/span>(weeks), numbered separately; names of instructors and lecturers must be <\/span>listed, indicating guest lecturers\/instructors. It cannot be attached separately! <\/span>For guest lecturers, attachment of CV is required in all cases!)<\/span><\/strong><\/p>\n

Basics of Intellectual Property Protection for Business \u2013 Renata Papp MD PhD – 4*45\u2019<\/span><\/p>\n

Market Analysis and Opportunity Assessment (Market research fundamentals, SWOT Analysis and <\/span>Competitive Positioning, Evaluating product opportunities, Basics of value proposition and targeting) <\/span>\u2013 David N Bernstein Visiting Professor \u2013 4*45\u2019<\/span><\/p>\n

Business Planning and Strategy (Introduction to Business Plans in Pharma\/Biotech, Strategic Planning <\/span>Basics, Partnerships and Collaborations, Simple Financial Planning, Risk Assessment and Mitigation) \u2013 <\/span>David N Bernstein Visiting Professor \u2013 6*45\u2019<\/span><\/p>\n

Business Case Workshop – Hands-on exercise: develop a mini business case for a product 4*45\u2019<\/span><\/p>\n

Case Study: Real-World Product Strategy 5*45\u2019<\/span><\/p>\n

Raising Capital \u2013 2*45\u2019<\/span><\/p>\n

Other courses with overlapping topics (obligatory, optional, or elective <\/span>courses) in interdisciplinary areas. To minimalize overlaps, topics should be <\/span>coordinated. Code(s) of courses (to be provided):<\/span><\/strong><\/p>\n

None<\/span><\/p>\n

Requirements for attendance, options for making up missed sessions, and <\/span>method of absence justification:<\/span><\/strong><\/p>\n

Full attendance is required. Completing additional e-learning materials are required to make up <\/span>missed courses. <\/span>Assessment methods during semester (number, topics, and dates of midterms <\/span>and reports, method of inclusion in the course grade, opportunities for makeup <\/span>and improvement of marks):<\/span><\/strong><\/p>\n

(number, topics, and dates of midterms and reports, method of inclusion in <\/span>the course grade, opportunities for make-up and improvement of marks)<\/span><\/strong><\/p>\n

Project work and online test at the end of the semester<\/span><\/p>\n

Number and type of individual assignments to be completed, submission<\/span><\/strong>
\ndeadlines:<\/span><\/strong><\/p>\n

Project work focused on a given topic, after the end of lectures<\/span><\/p>\n

Requirements for the successful completion of the course:<\/span><\/strong><\/p>\n

Project work approved + appropriate test results<\/span><\/p>\n

Type of assessment:<\/span><\/strong><\/p>\n

score-based<\/span><\/p>\n

Examination requirements (list of examination topics, subject areas of tests, <\/span>lists of mandatory parameters, figures, concepts and calculations, practical <\/span>skills, optional topics for the project assignment recognized as an exam and <\/span>the criteria for its completion and evaluation)<\/span><\/strong><\/p>\n

project work submitted \u2013 test completed. Test includes questions regarding all topics of the subject.<\/span><\/p>\n

Method and type of grading (Share of theoretical and practical examinations <\/span>in the overall evaluation. Inclusion of the results in the end-of-term <\/span>assessment. Possibilities of and conditions for offered grades.): (Share of <\/span>theoretical and practical examinations in the overall evaluation, Inclusion of <\/span>the results in the end-of-term assessment, Possibilities of and conditions for <\/span>offered grades)<\/span><\/strong><\/p>\n

score-based evaluation of the test results. Assessment of the project work: whether it reached at <\/span>least the satisfactory level.<\/span><\/p>\n

Formulation of the grade:<\/span><\/strong><\/p>\n

88 to 100 points: excellent (5)<\/span>
\n76-87,5 points: good (4)<\/span>
\n63-75 points: average (3)<\/span>
\n50-62 points: satisfactory (2)<\/span>
\nLess than 50 points: unsatisfactory (1)<\/span><\/p>\n

Signature of habilitated instructor (course coordinator) announcing the course:<\/span><\/strong><\/p>\n

Prof. Dr. P\u00e9ter Ferdinandy<\/span><\/p>\n

Signature of the director of the host institution:<\/span><\/strong><\/p>\n

Prof. Dr. P\u00e9ter Ferdinandy<\/span><\/p>\n

Date of submission:<\/span><\/strong><\/p>\n

5th January 2026<\/span><\/p>\n<\/div>\n<\/div>\n

Clinical Phase of Drug Development<\/a><\/p>\n
\n

Semmelweis University, Faculty of Medicine<\/span><\/strong>
\nPharmaceutical Innovation and Business Administration Master of Science<\/span><\/p>\n

Name of the host institution (and any contributing institution): <\/span><\/strong>Department of Pharmacology and Pharmacotherapy<\/span><\/p>\n

Name of subject:<\/strong> Clinical Phase of Drug Development<\/span><\/p>\n

in English:<\/strong> Clinical Phase of Drug Development<\/span><\/p>\n

in German:<\/strong> not applicable<\/span><\/p>\n

Credit value:<\/strong> 5<\/span><\/p>\n

Semester:<\/strong> 2025\/2026 2nd Semester<\/span><\/p>\n\n\n\n\n
Hours per semester<\/strong><\/span><\/td>\nLecture<\/strong><\/span><\/td>\nCourse work<\/strong><\/span><\/td>\nSeminar<\/strong><\/span><\/td>\n<\/tr>\n
\u00a0<\/td>\n16<\/span><\/td>\n\u00a0<\/td>\n6<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n\n
Hours per week<\/strong><\/span><\/td>\nLecture<\/strong><\/span><\/td>\nPractical lesson<\/strong><\/span><\/td>\nSeminar<\/strong><\/span><\/td>\n<\/tr>\n
Course blocks tailored to the students\u2019 employment obligations on Fridays and Saturdays<\/span><\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\nType of course:<\/span><\/strong><\/p>\n

compulsory<\/span><\/p>\n

Academic year:<\/span><\/strong><\/p>\n

2025\/2026<\/span><\/p>\n

Language of instruction (for optional and elective subjects):<\/span><\/strong><\/p>\n

English<\/span><\/p>\n

Course code:<\/span><\/strong><\/p>\n

(in the case of a new course, to be completed by the Dean\u2019s Office, following approval)<\/span><\/p>\n

Course coordinator name:<\/span><\/strong><\/p>\n

Prof. Dr. Istv\u00e1n Bitter<\/span><\/p>\n

Course coordinator location of work, telephone availability:<\/span><\/strong><\/p>\n

Semmelweis University, Department of Psychiatry and Psychotherapy<\/span><\/p>\n

Course coordinator position:<\/strong><\/span><\/p>\n

Professor<\/span><\/p>\n

Course coordinator Date and number of habilitation:<\/span><\/strong><\/p>\n

Objective of instruction and its place in the curriculum:<\/span><\/strong><\/p>\n

To equip students with the knowledge and practical skills needed to plan, and manage clinical trials in compliance with regulatory, ethical, and industry standards.<\/span><\/p>\n

Understanding the management of clinical trials is crucial during drug development because clinical trials are the backbone of demonstrating a drug\u2019s safety, efficacy, and quality before it reaches patients. Proper management ensures that trials are conducted efficiently, ethically, and in compliance with regulatory standards, which directly impacts the success of the drug development process.<\/span><\/p>\n

Method of instruction (lecture, group work, practical lesson, etc.):<\/span><\/strong><\/p>\n