Regulatory Issues of Medicinal Products
4
2024-2025
02035577
Pharmaceutical Sciences
Portuguese
Face-to-face
SEMESTRIAL
5.0
Compulsory
2nd Cycle Studies - Mestrado
Recommended Prerequisites
Pharmaceutical Technology; Quality Assurance.
Teaching Methods
Plenary lectures. Laboratory training to write-up a marketing authorization dossier.
Learning Outcomes
This unity concern with the regulamentar requirements associated with the registration of medicinal products. Are also evaluated all the issues related with the rules and procedures in force by EU or ICH (International Conference on Harmonization), in particular in what concern to the stability, Good manufacturing practices and validation, both of production and analytical methods.
Work Placement(s)
NoSyllabus
Plenary lectures:
Evaluation of legal requirements related with marketing authorizations (MA), following the centralized, descentralized mutual recognition and national procedures. Rules that must be follow either by companies (marketing authorization holders) and national authorities. Timetables of the different procedures. Type or variations. Separation between major, minor variations and notifications. CTD structure. Instructions how to fill in a marketing authorization either by physical or electronic submissions. Renewal of MA. Quality requirements. National rules according NTA (Notice to Applicants). Schedule for Renewals. Periodic safety Reports (PSUR). Concept of “born date” for international procedures. International referral, being Portugal the Reference Member State (RMS).
Practical
Analysis and group discussion of Notes for Guidance (guidelines) from EMEA and ICH.
Head Lecturer(s)
João José Martins Simões Sousa
Assessment Methods
Assessment
Resolution Problems: 25.0%
Exam: 75.0%
Bibliography
NTA - Volume 2 da publicação The Rules Governing Medicinal Products in the European Union (Vol. 2ª, 2B e 2C) Eudralex: Volumes 1 a 9.