Regulatory Process Management
5
2018-2019
02035665
Optional
Portuguese
Face-to-face
SEMESTRIAL
3.0
Elective
2nd Cycle Studies - Mestrado
Recommended Prerequisites
Pharmaceutical Technology, Quality Assurance; Regulatory Affairs.
Teaching Methods
Plenary lectures. Seminars.
Learning Outcomes
Unity in complement of Regulatory Affairs particulary focused for future profesionals, supported in two main areas: Post MA phase and extra EMA environments. The main objetive is to prepare professionals, namely experts in the elaboration of submission documents in the european area as well as other regulatory environments; construction of the CTD regional module; MA follow ups; worldwide auditing (FDA, GCC, Anvisa) and GMP Certification; prices and reibursements systems. Market access and contract manufacturing.
Work Placement(s)
NoSyllabus
Pleanry lectures
After MA issues: Variations. Evaluation of correct submission. Renewals.
Audits and Inspections. Manufacturing Licence and GMP Certification.
Organization of Regulatory Agencies: EMA and decentralized Agencies. Major international agencies.
Diferentiate procedures: art. 58º, conditional approval, compassionate use
Particular procedures: PRIME, pediatrics, special authorization.
Centralized Procedures: particulars, decision criteria, public information, scientific advice.
European referrals.
Price calculation system and reibursements and market access.
Seminars
Discussion and presentation of real cases.
Head Lecturer(s)
Catarina Joana Dias Neto Pratas Cardoso
Assessment Methods
Assessment
Report of a seminar or field trip: 15.0%
Resolution Problems: 15.0%
Exam: 70.0%
Bibliography
Eudralex: Volumes 1 a 9
GMP rules.
Quality Guidelines.
EMA and FDA websites.