Pharmaceutical Development and Project Management

Recommended Prerequisites

Theoretical and practical knowledge in medicine area, namely Pharmaceutics I, II and III and Regulatory affairs.

Teaching Methods

The classes are taught to enable to grasp integrated scientific knowledge. Subjects are systematized always aiming to achieve the competencies that are established. The presentation of the syllabus of each class is always preceded by a brief introduction. The syllabus will be complemented with case studies for a better comprehension. At the end of each lesson are highlighted the most relevant concepts and provided material support teaching, together with the summary, accompanied by the respective bibliography. Simultaneously, the classes are available in Nónio.

Learning Outcomes

Acquisition of skills concerning the pharmaceutical life time cycle and management. Complementary aspects from a clinical and regulatory point of view.

Work Placement(s)

No

Syllabus

Module 1: Life cycle of medicines: from the molecule to the market; Regulatory issues: Alignment with pharmaceutical development;
Module 2: Organization, administration and management of a R&D unit;
Module 3: Advanced tools at development and manufacturing;
Module 4: Quality control: resources, budget and management;
Module 5:Transference technology and up-scaling management;
Module 6: Product research and development process. Project management and Clinical Development.

Head Lecturer(s)

Ana Rita Ramalho Figueiras

Assessment Methods

Assessment
Exam: 100.0%

Bibliography

No final de cada aula lecionada será disponibilizada aos alunos a respetiva bibliografia de apoio aos conteúdos programáticos abordados.
At the end of each lecture, appropriate bibliography will be made available for the students.
Drug Development Programme Management; Barbara Ann Lead; Interpharm Press; Denver Colorado; 2000
Pharmaceutical Project Management; Edited by Tony Kennedy; volume 86;
Twenty – First Century Pharmaceutical Development; Editor: Peter Blaisdell; Interpharm Press; Denver Colorado; 2000.