Standard Operating Procedures and Data Management

Year
3
Academic year
2022-2023
Code
01008127
Subject Area
HEALTH SCIENCES AND TECHNOLOGIES
Language of Instruction
Portuguese
Mode of Delivery
Face-to-face
Duration
SEMESTRIAL
ECTS Credits
3.0
Type
Compulsory
Level
1st Cycle Studies

Recommended Prerequisites

Pharmaceutical development of medicines, Quality systems and Good Practices, Regulation in medicine Development.

Teaching Methods

The classes follow the masterful lesson model. The presentation of the syllabus of each class is preceded by an introduction where the main objectives of the matter are addressed. They are taught to enable students to grasp the knowledge transmitted in a logical and reasoning deductible. Whenever possible, the syllabus will be supplemented with examples, to enable a better consolidation of knowledge. The didactic support material will be available on Nónio.

Learning Outcomes

The curricular unit aims to acquire knowledge in the following areas:

- Document management of an organization;
- Structure of standard operating procedures (SOPs): coding, purpose, scope, references, terms and definitions, review, distribution procedure (flowchart), attachments ...;
- Development/creation of procedures;
- Identification of areas of activity where standard operating procedures are applicable (Example: Quality management, clinical trials, pharmacovigilance, …);
- Preparation and planning of training actions related to information flow/training of the SOPs.

Work Placement(s)

No

Syllabus

Theorical lectures
Document management of an organization. Flow identification: document management (standards, records, work instructions), productivity and file of an organization.
Presentation of the activities within the organization created: Quality Assurance, Clinical Trials and Pharmacovigilance.
Procedures: Introduction; Process; SOP General format; Examples.
Identification of the required items for the preparation of the SOPs: Purpose; Application Field; Definitions and Abbreviations; Related documents; References, procedure itself (flowchart: flow, description and responsibilities); Requirements; Attachments.
Training and further distribution of registration on the procedures and forms within different areas: training procedure and application forms.

Practical lectures
Bibliographical research related to identified activities and for which the development of SOP is needed.
Development/creation of standard operating procedures.


Head Lecturer(s)

Filipa Alexandra Mascarenhas Melo

Assessment Methods

Assessment
Analysis of the proposed group work according to the activity areas, Theoretical and practical Continuous Evaluation: 20.0%
Exam: 80.0%

Bibliography

Guidelines: guidance for preparing standard operating procedures (SOPs)
Normas da Gestão da Qualidade (ISO 9001:2008)
Legislação/guidelines aplicáveis às áreas de actividade identificadas:
• Eudralex: Volumes 9A Pharmacovigilance guidelines
• EudraLex - Volume 10 Clinical trials guidelines
• Guidelines europeias e ICH.