Documentation and Good Regulatory Practices

Recommended Prerequisites

Pharmaceutical Technology; Management and Quality Assurance / Regulatory Affairs Medicines / Pharmaceutical Technology; Quality Assurance / Regulatory issues of medicinal products.

Teaching Methods

Plenary lectures. Laboratory training to write-up a marketing authorization dossier.

Learning Outcomes

Be aware of the type of documentation submission in order to get marketing authorization. Knowledge of the relevant guidelines and technical topics. Organization of documental dossier. Good pratices linked with the general procedures. National and EU rules and Guidelines.

Work Placement(s)

No

Syllabus

Plenary lectures:

Identification of national and EU Institutions and their role on the approval of medicinal products. Specific committees (EWP, QWP). Recognition of legal basis supporting MA (marketing authorization). General documentation required for national, mutual recognition, decentralized and centralized procedures. Calendar of these type of submissions. Variations: type and conditions/documentation applied. Renewals. Requirements in terms of quality and integration with the structure of the Common Technical Dossier. Guidelines applied. PSURs.

CMD as legal referee in EU procedures. Portugal as EMR. Good practice applied to EMR and CMS.

Practical

Analysis and group discussion of guidelines from EMA and ICH.

Head Lecturer(s)

Carla Sofia Pinheiro Vitorino

Assessment Methods

Assessment
Synthesis work: 25.0%
Exam: 75.0%

Bibliography

Eudralex: Volumes 1 a 9

Specific Guidelines adopted by EMA/ICH as the basis to fill in the following documentation Modules: 3, 4 and 5

Material de apoio às aulas.