teme konferencije/conference topics
EKSTERNE PROVERE/EXTERNAL AUDITS
-
Provere od treće strane - Rizici i
benefiti/Risks and Benefits of 3rd Party Audits
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Nova poglavlja i aneksi GMPa - izazovi u
proveri/New Chapters and Annexes in GMP - Challenges for Audits
-
Regulatorni zahtevi u svrhu izdavanja dozvole za
distributere ljudskih tkiva i ćelija/The Regulatory Requirements for the
Purpose of Issuing Human Tissue and Cells License for Pharmaceutical
Wholesalers
- Dobra praksa u farmakovigilanci i Dobra Distributivna Praksa: Ka regulatornom usklađivanju i zajedničkim ciljevima/Good Pharmacovigilance Practice and Good Distribution Practice: Towards Regulatory Alignment and Shared Objectives
INSPEKCIJE KOD NOSIOCA DOZVOLE/INSPECTION AT MAH
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Inspekcija u oblasti oglašavanja i promocije
lekova i medicinskih sredstava/Inspection on Advertising of Medicines and
Medical Devices
- GVP inspekcija/GVP inspection - Reklamacije i povlačenja: zahtevi za MAH/Complaints and Recalls: Requirements for MAH
- Regulatorni okvir - primjena dermalnih filera u Bosni i Hercegovini/Regulatory Framework - Application of Dermal Fillers in Bosnia and Herzegovina
PANEL DISKUSIJA/PANEL DISCUSSION: Temperaturna
odstupanja/Temperature excursions
-
Temperaturna odstupanja iz perspektive
proverivača/Temperature Excursions from Auditors’ Perspective
-
Studije slučajeva/Case Studies: Skladište;
Žalbe pacijenata; Transport; Procena rizika/Warehouse; Patient Complaints;
Transport; Risk Assessment