Regulatory issues of medicinal products

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)

No

Syllabus

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