Applied Drug Development, Caps - University of W

The Applied Drug Development Capstone Certificate program at the University of Wisconsin-Madison equips individuals with the skills and knowledge to contribute effectively to drug development teams. The program covers the drug development process, regulatory practice, pharmaceutical economics, and project management. Graduates are prepared for careers in the pharmaceutical industry, academia, or government agencies involved in drug development and regulation.

Program Outline

Degree Overview:

The Applied Drug Development Capstone Certificate program at the University of Wisconsin-Madison is designed to equip individuals with the foundational skills and knowledge necessary to contribute effectively to drug development teams. The program aims to produce graduates who are proficient in the basic conceptual and methodological underpinnings of drug development and can apply their expertise to real-world problem-solving.

Objectives:

Develop a comprehensive understanding of the drug development process, from early discovery to regulatory approval.
Acquire essential skills in regulatory practice, pharmaceutical project management, and pharmaceutical economics.
Foster critical thinking, analytical, and problem-solving abilities in the context of drug development.
Prepare graduates for careers in the pharmaceutical industry, academia, or government agencies involved in drug development and regulation.

Program Description:

The Applied Drug Development Capstone Certificate consists of four core courses:

PHM SCI 762: The Drug Development Process I
PHM SCI 763: The Drug Development Process II
PHM SCI 751: Introduction to Regulatory Practice
PHM SCI 753: Pharmaceutical Economics and Project Management
PHM SCI 752: GxP (Good Practice): Working in a Regulated Environment

Outline:

Core Courses:

PHM SCI 762: The Drug Development Process I

Introduction to the drug development process
Target identification and validation
Preclinical development
Investigational new drug (IND) application

PHM SCI 763: The Drug Development Process II

Clinical development
Phase I-III clinical trials
Data analysis and interpretation
New drug application (NDA) submission

PHM SCI 751: Introduction to Regulatory Practice

Overview of regulatory agencies and their role in drug development
Regulatory requirements for drug development
Good laboratory practices (GLP) and good manufacturing practices (GMP)
Clinical trial design and conduct

PHM SCI 753: Pharmaceutical Economics and Project Management

Principles of pharmaceutical economics
Cost-benefit analysis
Drug pricing and reimbursement
Project management for drug development

Elective Courses:

PHM SCI 752: GxP (Good Practice): Working in a Regulated Environment

Good laboratory practices (GLP)
Good manufacturing practices (GMP)
Good clinical practices (GCP)
Quality assurance and control in drug development

Assessment:

The assessment methods used in the Applied Drug Development Capstone Certificate program include:

Exams: Midterm and final exams are used to assess students' understanding of the course material.
Assignments: Homework assignments, case studies, and projects are used to evaluate students' ability to apply their knowledge to practical situations.
Presentations: Students may be required to present their research findings or case studies to the class.
Participation: Class participation and engagement are also considered in the assessment process.

Teaching:

The Applied Drug Development Capstone Certificate program is taught by experienced faculty members from the School of Pharmacy at the University of Wisconsin-Madison. These faculty members are actively involved in drug development research and have extensive industry experience. The program utilizes a variety of teaching methods, including:

Lectures: Faculty members present the core concepts and theories of drug development.
Discussions: Students engage in discussions and debates on current topics and issues in drug development.
Case studies: Students analyze real-world case studies to apply their knowledge to practical scenarios.
Guest speakers: Industry professionals and regulatory experts are invited to share their insights and experiences with students.

Careers:

Graduates of the Applied Drug Development Capstone Certificate program may pursue careers in various fields related to drug development, including:

Pharmaceutical industry: Research and development, clinical operations, regulatory affairs, marketing, and sales
Academia: Teaching and research in drug development, pharmacology, and toxicology
Government agencies: Regulatory bodies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
Nonprofit organizations: Advocacy and research in drug development and access to medicines

Applied Drug Development, Capstone Certificate

Program Overview