Universitat Internacional de Catalunya

Product Development in the Pharmaceutical Industry

Product Development in the Pharmaceutical Industry
3
14865
4
First semester
op
Main language of instruction: Spanish

Other languages of instruction: Catalan, English

Teaching staff


Dr. MARFÀ BRUIX, Santiago - smarfa@uic.es

Questions will be resolved before or after class. To resolve non-face-to-face questions, they will be done by videoconference.

Introduction

The course presents the process of developing biomedical products, including medicines and in vitro diagnostic products. Each of these areas has specific features that will be analysed throughout the course, at the levels of R&D, regulation and market access, among others. An ethical and sustainable approach is promoted, aligned with SDGs 3, 4, 5, 8, 9 and 12.

  • SDGs to which this course contributes: SDG 3 (Good Health and Well-being), SDG 4 (Quality Education), SDG 5 (Gender Equality), SDG 8 (Decent Work and Economic Growth), SDG 9 (Industry, Innovation and Infrastructure) and SDG 12 (Responsible Consumption and Production).

Pre-course requirements

It is recommended to have taken and to recall the concepts from Introduction to Bioenterprise.

Objectives

The teaching staff aims to explain the life cycle and key principles of biomedical product development, including both drugs and in vitro diagnostic products. It also seeks to provide knowledge about regulatory, quality, and market access considerations that influence strategic decision-making throughout the process. During the course, the objective is to foster the ability to identify opportunities for value creation and market expansion from a business development perspective, while also guiding students in the clear, ethical, and collaborative communication of proposals and results. Finally, the course will introduce sustainability and responsibility criteria to help understand the impact of product development on society, in alignment with the Sustainable Development Goals (SDGs 3, 4, 5, 8, 9, and 12).

Competences/Learning outcomes of the degree programme

  • CN14 - Identify the principles of biomedical sciences related to health, as well as the basic concepts and tools that have an impact on Biomedical Sciences and allow them to work in any of its fields (biomedical companies, bioinformatics labs, research laboratories, clinical analysis companies, etc.).
  • CP05 - Apply biological foundations in the search for practical solutions to health problems, following ethical standards and scientific rigour and respecting fundamental equal rights between men and women, and the promotion of human rights and the values inherent in a peaceful society of democratic values that includes inclusive, non-discriminatory language without stereotypes.

Learning outcomes of the subject

Upon completing the course, students should be able to:

  • Understand the development process of biomedical products, from research to commercialization, and their impact on therapeutic areas.

  • Analyze regulations, intellectual property, and market access in the pharmaceutical industry.

  • Design market access and international expansion strategies for pharmaceutical and diagnostic products.

  • Assess the importance of pharmacovigilance and post-marketing monitoring.

  • Integrate product development knowledge into public funding and commercialization strategies.

Syllabus

Pharmaceutical development(Related SDGs: SDG 3, SDG 9, SDG 12)

  • Therapeutic areas

  • Pipeline

  • Types of medicines (synthetic, biological)

  • Intellectual property

  • Preclinical and clinical phases

  • Generics and biosimilars

  • Registration requirements and types

  • Pharmacovigilance

  • Vaccines

In vitro diagnostic (IVD) product development(Related SDGs: SDG 3, SDG 9, SDG 12)

  • Types and development phases

  • Specific regulation

Market access(Related SDGs: SDG 3, SDG 8, SDG 12)

  • Efficiency (economic evaluation) and budget impact

  • Payment and reimbursement models

  • From product development to public funding: steps to follow

Expansion to international markets(Related SDGs: SDG 8, SDG 9, SDG 12)

  • Expansion strategies

  • Business models

Teaching and learning activities

In person



Fully on-site modality.

  1. Lectures – 16 hours: knowledge transfer to the whole group.

  2. Case method (CM) – 14 hours: case resolution, debates and group presentations with concepts introduced as needed and under supervision.

SDG contribution within the methodology: SDG 4 (active learning and formative assessment); SDG 5 (inclusive dynamics and co-assessment with a gender-equality lens); SDG 9 (focus on processes/technologies); SDG 3 and SDG 8 (analysis of health and socio-economic impact in cases); SDG 12 (reflection on product life cycle and efficient use of resources).

Evaluation systems and criteria

In person



First sitting:

  • Class participation and attitude: 10%.

  • Presentation of the Pipeline and Product Development (teamwork): 40%. Study and oral presentation of (a) the pipeline of one of the world’s major pharmaceutical companies chosen by each group, together with (b) the development of one product, detailing the different phases and the information required up to delivering the value dossier to the public healthcare payer.

  • Multiple-choice exam: 50%.

Second and subsequent sittings:

  • Participation (10%) and presentation (40%) grades from the first sitting are retained.

  • Multiple-choice exam: 50%.

  • NOTE: In second and later sittings, the maximum achievable grade is 6/10.

General conditions and minimums:

  • To compute the final average, a minimum of ≥5/10 in the Pipeline & Product Development Presentation is required.

  • To compute the final average, a minimum of ≥4/10 in the multiple-choice exam is required.

  • Minimum overall grade to pass the course: 5/10.

  • Attendance: failure to meet a minimum attendance of 75% will reduce the participation score.

  • There is no midterm exam.

  • Negative marking in multiple-choice exams: –0.33 per wrong answer when there are 4 options (1 point for the correct one) and –0.25 when there are 5 options.

SDG alignment in assessment: the exam and participation ensure SDG 4 (quality education). The presentation (pipeline, development and expansion/BD) must include impact and sustainability analysis, contributing to SDG 3, SDG 8, SDG 9 and SDG 12, and a gender-equality and inclusion perspective (SDG 5) will be valued.

Bibliography and resources

  • Kolchinsky, P. The Entrepreneur’s Guide to a Biotech Startup.

  • ICH Guidelines (E6(R2) Good Clinical Practice; E8(R1) General Considerations for Clinical Studies).

  • Regulation (EU) 2017/745 (MDR) on medical devices; Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices.

  • EMA and AEMPS guidance for authorisation procedures and pharmacovigilance.

  • Teaching resources and audiovisual materials to be indicated during the course.

Evaluation period

E: exam date | R: revision date | 1: first session | 2: second session:
  • E1 14/01/2026 A21 18:00h
  • E2 18/06/2026 A10 18:00h
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