Medicine Development Regulation

Recommended Prerequisites

Pharmaceutical dosage forms (analysis and production); English.

Teaching Methods

Teaching methods: Theoretical lessons tutorials Theoretical and practical - Presentation and discussion of guidelines mentioned in the program. A new paediatric medicine purposed by the students.

Learning Outcomes

Knowing the legal texts relating to pharmaceutical development. Acquire skills for the development of drugs supported on regulatory principles. Knowing interconnect knowledge of the chemical and physical areas of pharmaceutical technology in order to delineate studies to drug registration. Collect on databases the information that is necessary to the introduction in the market of new medicines.

Work Placement(s)

No

Syllabus

The Regulatory System of the drug in the European Union Pharmaceutical development of medicines (adults and paediatric use): 1) information to include on CTD (module 3); 2) definition of: “control strategy”; “critical process parameter”; “critical quality atribute”; “design space”; “quality by design”; “quality target product profile” Preclinical safety Clinical efficacy and safety The European system and its operation National registration system and decentralized (mutual recognition) Centralized system and EMEA The operation of the several CHMP and CXMP The scientific advice from the EMEA / CHMP The European coordination of regulatory authorities and the free movement Pharmacovigilance system in Portugal and in the European Union Identification of the risk factors in adverse reactions and drug interaction T/P
A new paediatric medicine proposed by students (information that should e included on CTD module 3)
Student oral presentations (guidelines).

Head Lecturer(s)

Olga Maria Fernandes Borges Ribeiro

Assessment Methods

Assessment
Other: 30.0%
Exam: 70.0%

Bibliography

Note for guidance on pharmaceutical development-EMEA/CHMP/167068/2004-ICH;
Concept paper on the development of a quality guideline on pharmaceutical development of medicines for paediatric use- EMEA/138931/2008;
Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medical products in clinical trials- CHMP/QWP/185401/2004 final
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and marketing authorization for Pharmaceuticals - M3(R2) - 11 June 2009
Diretiva 2005/28/CE da CE, de 08/04/2005
DL nº 129/92, de 06/07
Lei dos ensaios clínicos com medicamentos de uso humano – DL nº 46/2004 - transpõe para a ordem jurídica nacional a Directiva nº 2001/20/CE.
Portaria nº 1005/92 e Portaria nº 466/95
Alteração aos nºs 8º, 23º, 48º e 49º da Portaria nº 1005/92, de 23/10
Lei nº 176/2006 de 30/08 - Estatuto do Medicamento
Lei nº 21/2014, de 16/04 (Lei da Investigação Clínica).