Medicine Development Regulation

Recommended Prerequisites

Pharmaceutical Development of the medicines.

Teaching Methods

Teaching methods:

Theoretical lessons tutorials

Theoretical and practical - Presentation and discussion of guidelines mentioned in the program by students.

A new paediatric medicine purposed by the students

Learning Outcomes

Learning outcomes (ver nota anterior. Introduzir texto em inglês)

Knowing the legal texts (Guidelines) 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. Know the legislation in force regarding medical devices

Work Placement(s)

No

Syllabus

The Regulatory System of the drug in the European Union (ICH, OMS, EMA e INFARMED)

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

The European system and its operation

National registration system and decentralized (mutual recognition)

Centralized system and EMA

The operation of the several CHMP and CXMP

The scientific advice from the EMA / CHMP

The European coordination of regulatory authorities and the free movement

Medical devices

T/P

A new paediatric medicine proposed by students (information that should be included on CTD module 3)

Student oral presentations (information on web pages of ICH, EM and INFARMED)

Analysis of practical cases of pharmaceutical development according to the Quality by Design approach

Head Lecturer(s)

Carla Sofia Pinheiro Vitorino

Assessment Methods

Assessment
Attendance & participation in theoretical classes; T/P classes are mandatory: 1.0%
Laboratory work or Field work: 30.0%
Exam: 69.0%

Bibliography

•          Note for guidance on pharmaceutical development-EMEA/CHMP/167068/2004-ICH;

•          ICH guidelines topic Q8, Q9 and Q10

•          Guideline on pharmaceutical development of medicines for paediatric use- EMEA/138931/2008;

•          Guideline on manufacture of the finished dosage form EMA/CHMP/QWP/245074/2015

•          Guideline on excipients in the dossier for application for marketing authorization of a medical product - EMEA/CHMP/QWP/396951/2006

•          Guideline on summary of requirements for active substances in the quality part of the dossier - CHMP/QWP/297/97

•          ICH topic Q 6 B - CPMP/ICH/365/96 (Biological products)

•          Guideline on plastic immediate packaging materials

•          Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medical products in clinical trials - CHMP/QWP/185401/2004 final

•          Guideline on quality of transdermal patches - EMA/CHMP/QWP/608924/2014

•          Pharmaceutical qu