PROGRAM – PROGRAMME

Četvrtak, 1. oktobar 2015. – Thursday, October 1st 2015

Teme – Themes

Predavači –  Speakers

Update on the EU GMP Regulations Dr Bernd Renger, Renger Concultancy
OOS results; regulatory expectations and remediation approaches Dr Christopher Burgess, EQPA
The role of QP in assuring the GMP compliant APIs Andrej Ferlan, Solutiones d.o.o., Consulting, Education and Training, Ljubljana, Slovenia
Strategic development plan for Drug Agency of Republic of Macedonia Marija Darkovska, Macedonian Drug Agency
Modern Data and Documentation Management and recording.State of the art Data and Document Structuring:

Data Integrity ‐Electronic Signatures vs. digital Signatures.

Electronic Signature Law and requirements on signing electronically

Stephan Dresen, Actavis, Weiterstadtu, Germany
PAT i Real Time Release Prof dr Svetlana Ibrić, Farmaceutski fakultet – Univerzitet u Beogradu (Faculty of Pharmacy – University of Belgrade)

Petak, 2. Oktobar 2015. – Friday, October 2nd 2015

Kontinuirana proizvodnja i puštanje leka u prometContinual production and release into the market Mate Poropat, Jadran‐Galenski Laboratorij d.d., Croatia
The revised Annex 16 of the EU GMP Guide and is Implications for QPs Dr Bernd Renger, Renger Concultancy
What QPs need to know about statistics Dr Christopher Burgess, EQPA

TRI PARALELNE RADIONICE – THREE PARALLEL WORKSHOPS

Radionica 1 Upravljanje rizicima tokom transporta lekovaWorkshop 1 Risk management during drugs transportation
Radionica 2 OOS u studijama stabilnostiWorkshop 2 OOS in stability studies
Radionica 3 Uloga QP‐a u upravljanju konfliktnim situacijamaWorkshop 3 QP role in managing conflict situations