Program Overview

Program Overview

The Master of Advanced Studies (MAS) in Drug Discovery and Clinical Development is a comprehensive program designed for professionals in the pharmaceutical industry, biotechnology sector, and international organizations. The program aims to provide in-depth understanding of drugs and medical devices in clinical research and development.

Objectives

• Provide essential business knowledge of drug and medical devices in clinical research and development
• Give health professionals the tools to comply with the highest scientific and ethical standards in clinical research
• Empower physicians and health scientists to lead clinical trials within hospitals, pharmaceutical, and biotechnology companies
• Enable health professionals to gain a strategic vision of clinical development and navigate the complexities of bringing new medicinal products to the global market

Audience

The program is tailored for medical doctors, biologists, pharmacists, veterinarians, nurses, biochemists, and other professionals involved or wishing to gain skills and knowledge in the field of drug discovery and development.

Learning Outcomes

• Understand the stakes, challenges, and opportunities of drug discovery and development
• Master the fundamental scientific and ethical principles of drug discovery and development
• Gain knowledge of Good Clinical Practices (GCP) and of clinical research regulations in Switzerland, Europe, and the United States
• Learn how to navigate clinical trial authorization and marketing authorization processes
• Master effective planning and management for clinical trials
• Successfully manage partnerships with pharmaceutical and biotechnology partners
• Understand the issues related to research subject protection
• Understand and take up the challenges of new technologies and personalized medicine

Program Structure

The program consists of 13 modules, covering a wide range of topics from introduction to product development to new perspectives in product development. Each module is designed to provide comprehensive knowledge and skills in specific areas of drug discovery and clinical development.

Modules

1. Introduction to Product Development: Challenges and prospects, definition of product development, success and failure, fundamentals of health economics, and regulatory framework.
2. Principles and Methods of Clinical Research: Development of research questions, choice of endpoints, overview of different study designs, statistical methods, and critical review of publications.
3. Ethical and Regulatory Aspects: Fundamentals of clinical research ethics, informed consent, purpose and function of research Ethics Committees, regulatory requirements, and good clinical practices.
4. Non-Clinical Development and Clinical Pharmacology: Fundamentals of pharmacology, safety assessment, drug metabolism, and early phases of clinical development.
5. Safety Management during Product Development: Risk management, safety monitoring, safety assessment, and pre- and post-marketing pharmacovigilance.
6. Medical Statistics and Trial Methodologies: Statistical principles, clinical trials designs, development of study protocols, and pharmaco-epidemiology.
7. Clinical Trial Planning and Set-Up: Essentials of Clinical Trial Management, budget development, investigator site selection, and clinical trial documents.
8. Clinical Trial Conduct and Close-Out: Clinical trial monitoring, recruitment, data collection, management of investigational product, and risk management.
9. Audits and Inspections: Quality management systems, audit, purpose and conduct of regulatory inspections, and site preparation.
10. Chemistry, Manufacturing, and Controls: Explanation of GMP, quality assurance, qualification and validation, raw materials, and manufacturing for clinical trials.
11. Regulatory Strategy in Product Development: Role and responsibilities of regulatory agencies, international regulatory environment, EU, Swiss, US legislation, and regulatory strategies.
12. Medical Devices: Overview of medical devices development, EU regulations, qualification and classification, clinical investigation, and market access strategy.
13. New Perspectives in Product Development: Personalized medicine, omics and big data, use of data and Artificial Intelligence, advanced therapeutic medicinal products, and new therapeutic approaches.

Admission Criteria

• Medical degree or Masters/Bachelors degree in Life Sciences or an equivalent qualification
• At least one year of relevant professional experience for Bachelors degree holders from a Swiss University of Applied Sciences
• Good command of English (level B2C1)
• Candidates attending the program during working hours must provide written authorization from their employer

Application File

• Copy of identity document
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter
• Two reference letters
• Written authorization from employer, if applicable

Fees

• CHF 15500.- for the MAS (13 modules)
• CHF 1000.- for a 1-day module
• CHF 1400.- for a 2-day module
• CHF 1800.- for a 3-day module
• CHF 2200.- for a 4-day module

Pedagogical Method

The program uses lectures, interactive seminars, and workshops, all conducted in English.

Partnerships and Accreditation

The program is accredited by several professional organizations, including Swissethics and the Swiss Association of Pharmaceutical Professionals.

Contribution to Sustainable Development Goals

The program contributes to various Sustainable Development Goals by enhancing knowledge and skills in drug discovery and clinical development, ultimately improving public health and well-being.