Drug Development and Regulatory Affairs

Pharmacokinetics and Pharmacodynamics, Pharmacotherapy, Pharmacology, Pharmacoepidemiology and Pharmacovigilance.

M1. The learning process value the skills of learning and the collaborative work. From the bibliographic support recommended, students will integrate the knowledge trough working groups and holistic analyses of practical cases to report in the classroom. The teacher acts as a facilitator of learning process.

M2. The learning will be done through the study of theory, analysis and discussion of practical cases. The theoretical component uses the expository method, in a student-centered learning context.

M3. Working groups, with collaborative knowledge dissemination tools, being their commitment and relation with these means relevant factors to learn. The practice is action-oriented, where the student is challenged to solve and roleplaying, clinical cases. (Problem Based Learning).

The acquisition of knowledge is proven through a written evaluation test (60%) and carrying out a bibliographic research work with presentation and/or through problem-based learning cases discussion (40%)

O1 – Deepen the knowledge previously acquired about the drug development in pre-clinical and clinical components, providing the respective regulatory framework.

O2 – Identify fundamental ethical issues for conducting pre-clinical and clinical research.

O3 – Describe the legal and regulatory framework for clinical research.

O4 – Explain the concepts related to the conception and design of clinical studies.

O5 – Describe the most used study designs.

O6 – Understand the principles of regulation of medicines and healthcare products, the role of regulatory authorities and regulatory systems in Europe.

O7 – Understand the drug registration procedures and marketing authorization process.

O8 – Acquire basic skills in intellectual property.

1. Pre-clinical research
   1.1 Overview of the drug development process
   1.2 Pre-clinical evaluation
   1.3 Types of experimental design
   1.4 In silico, in vitro and in vivo assays
   1.5 Cell models
   1.6 Animal experimentation
   1.7 Ethical issues of using animal models

2. Clinical research
   2.1 General concepts about clinical trials (CT)
   2.2 Regulatory and ethical framework of CT
   2.3 Types of CT
   2.4 Primary/secondary endpoints; creased endpoints
   2.5 CT Phases
   2.6 Non-inferiority, equivalence and superiority studies
   2.7 Registration of a CT
   2.8 CT Protocol
   2.9 Informed consent
   2.10 Monitoring of a CT

3. Regulatory Affairs
   3.1 Regulatory structure in Portugal and Europe
   3.2 Drug Marketing Authorization Dossier (Common Technical Document)
   3.3 Different process of Marketing Authorization
   3.4 Procedures: Centralized, Decentralized, Mutual and National Recognition
   3.5 European and ICH Guidelines

4. Industrial and intellectual property
   4.1 Patents
   4.2 Regulation and content of patents

NAO

Principal

• Spilker, Bert (2009), Guide to drug development: a comprehensive review and assessment (1st), Wolters Kluwer Health/Lippincott Williams & Wilkins
• Hu, Feifang and Rosenberger, William F. (2006), The theory of response-adaptive randomization in clinical trials (1st), Wiley, Hoboken, NJ

Secundary

• Tom Brody. Clinical Trials. Academic Press, 1st edition, 2012
• Richard Chin & Bruce Y. Lee. Principles and Practice of Clinical Trials Medicine, Elsevier, 2008
• Lei n.º 21/2014 de 16 de Abril de 2014 – Lei da investigação clínica
• EudraLex – Volume 10 – Clinical trials guidelines
• The Rules Governing Medicinal Products in the European Union (Vol. 2ª, 2B e 2C) Eudralex: Volumes 1 a 9.