Program konferencije

Teme Predavači

The myth about data integrity, data quality and GMP data management. 

What is the rational for your Quality Decisions and Batch Certification?

Markus Roemer,

comes compliance services

How to ensure the regular supply of medicinal products?

Challenges and practise from HALMED

Mr pharm Ana Boban, Inspektor ekspert dobre 

proizvođačke prakse i farmakovigilancije HAMLED

Stability package for Active Ingredients (APIs)  Jordi Ruiz Combalia, Spain
Integral software concept - road to integral compliance

M. sc. Damir Stanić, Amplexor

Vicepresident Business Development LifeScience

Handling post-approval changes globally – the need

for driving global regulatory convergence

Nevena Miletić, Regulatory Policy Lead – 

EEMEA, F. Hoffmann-La Roche Ltd

Kvalitet i bezbednost lekova: pacijent u fokusu

Ivan Kovačević, Medical Manager,

Medical Department, Europe, GSK

Regulatorni propisi u oblasti odstupanja kvaliteta leka i uloga QP

Mr ph spec. Svjetlana Mihaljica, 

Koordinator poslova kontrole kvaliteta

u Nacionalnoj kontrolnoj laboratoriji ALIMS

Tri paralelne radionice:

Radionica 1. Upravljanje timovima: šta QP treba da zna?
Radionica 2. Tumačenje EU GMP Aneksa 16
Radionica 3. QP Scenariji - koliko ozbiljni mogu da budu?