[Monday, June 18, 2012] – Day 1 |
|
| 10:00 – 17:00 | Registration for the conference |
| 10:30 – 11:15 | Opening of the conference – Opening speech of the organizers, representatives of regulatorybodies and public organizations |
| 11:15 – 12:00 |
Report 1 Modern System of Quality Control of Medicines Natalya Bunyatyan |
| 12:00 – 12:30 | Coffee break |
| 12:30 – 13:15 |
Report 2 The Experienceof the Republic of Kazakhstan in the Registration of the Medicines and the Establishment of National Pharmacopoeial Standards By Ardak Tulegenova |
| 13:15 – 14:00 |
Report 3 Practice of Incorporating the ICHQ 10 Principles in the Quality System of Modern Pharmaceutical Company By Svetlana Skorik |
| 14:00 – 15:00 | Lunch break |
| 15:00 – 15:45 |
Report 4 Management of Corrective and Preventive Actions (CAPA) By Alla Teterina |
| 15:45 – 16:30 | Roundtable discussion |
| 19:00 – 23:00 | Banquet |
[Tuesday, June 19, 2012] – Day 2 |
|
| 10:30 – 11:15 |
Report 5 Documentation of Change Control By Natalia Gudushauri |
| 11:15 – 12:00 |
Report 6 Risk Assessment in Medicines Development By Veniamin Khazanov |
| 12:00 – 12:30 | Coffee break |
| 12:30 – 13:15 |
Report 7 New FDA Approaches to the Process Validation By Roman L`oretts |
| 13:15 – 14:00 |
Report 8 Self-Inspection under GMP: the Experience of Foreign Companies By Andrew Meshkovskii |
| 14:00 – 15:00 | Lunch break |
| 15:00 – 15:45 |
Report 9 Validation of self-inspection processes By Igor Topnikov |
| 15:45 – 16:30 | Roundtable discussion |
| 21:00 – 24:00 | Football club |
[Wednesday, June 20, 2012] – Day 3 |
|
| 10:30 – 11:15 |
Report 10 Suppliers’ Audit By Valentina Vigran |
| 11:15 – 12:00 |
Report 11 Review of Regulationson the Results of the FDA Inspections for 2010-2011 The speaker is being clarified |
| 12:00 – 12:30 | Coffee break |
| 12:30 – 13:15 |
Report 12 Removal of the Notorious "Human Factor" The speaker is being clarified |
| 13:15 – 14:00 |
Report 13 Leadership -What OOO (KLO) Can Learn from the Climbers and Tourists By Taras Kalita |
| 14:00 – 15:00 | Lunch break |
| 15:00 – 15:45 |
Report 14 Risk Assessment at Creating the Incentives System for the Quality Director By Elena Lifanova |
| 15:45 – 16:15 | Official closing of the conference |
| 17:00 – 19:00 | Audit of the production sites |
[Thursday, June 21, 2012] – Day 4 |
|
| 10:30 – 12:00 |
Master-class European Certification Experience of Authorized Persons The speaker is being clarified |
| 12:00 – 12:30 | Break |
| 12:30 – 14:00 |
Master-class Risk Assessment at Selecting Project Decisions/Solutions on the Personnel Separation and Material Flows By a FAVEA representative |
| 14:00 – 15:00 | Lunch break |
| 15:00 – 16:30 |
Master-class Remain a Firefighter or Become a Therapist? Professional Selection of Quality Manager(Overcoming the Personnel Resistance) By Aleksandr Aleksandrov |