Regulatory Process Management

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)

No

Syllabus

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.