Postgrau en Farmacovigilāncia

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informaciķ
Matricula't
Programa

1. Introducciķ i bases regulatōries
1.1 Introducciķ
1.2 Legislaciķ espanyola
1.3 EMA (Agčncia Europea del Medicament)
1.4 Legislaciķ global

2. Reaccions adverses
2.1 Reaccions adverses
2.2 Management or reporting of adverse reactions to medical products
2.3 E2B

3. Informes d’autoritzaciķ i estudis postautoritzaciķ de seguretat
3.1 Periodic Safety Update Reports
3.2 Post-authorisation Safety Studies
3.3 Signal Management

4. Sistema de Qualitat I: Sistema de Farmacovigilāncia
4.1 Pharmacovigilance Systems and their Quality Systems
4.2 Pharmacovigilance System Master File

5. Sistema de Qualitat II: monitoritzaciķ del Sistema de Farmacovigilāncia
5.1 Pharmacovigilance Inspections
5.2 Audits

6. Gestiķ del risc
6.1 Risk Management Systems
6.2 Additional Monitoring
6.3 Tools, Educat. Mats & Effectiveness Measurements for Risk Minimisation

7. Comunicaciķ i gestiķ de crisi
7.1 Public Participation in Pharmacovigilance
7.2 Continuous Pharmacovigilance, Ongoing Benefit-Risk Evaluation, Regulatory Action and Planning of Public Communication
7.3 Incident Management
7.4 Referral Procedures for Safety Reasons
7.5 Safety Communication

8. Vigilāncia de productes sanitaris
8.1 Vigilāncia de Productes Sanitaris
8.2 Vigilāncia de Productes Cosmčtics

Presentaciķ
Objectius
Destinataris
Quadre docent
Sortides professionals
Descomptes i beques
Vídeo de presentaciķ