Moderator of the Event: Anna Plesovskikh, Managing Partner, PharmaPharm
13:10-13:20. Registration of the participants
13:20-13:30. Signing Partnership agreement between PharmaPharm & GMP News
13:30-14:20. Discussion panel: «Data integrity management: key points»
Main conceptions:
- Digitalization trends. Big Data. Main milestones. Time challenge
- Data integrity and security in GxP: regulatory requirements assessment
- Data integrity guide: competency review
- Quality management & digitalization: main control points
- Data integrity in pharmaceutical manufacture. The implementation results in a dynamic perspective (R-Pharm as an example)
- Data integrity (based on Agilent OpenLAB CDS 2 software)
- Electronical system for development of registration dossier for pharma product (as a tool of ensuring constant data)
- Actual ISPE documents for ensuring data integrity. Conception and benefits of using ISPE GAMP Guide and the ISPE GAMP 5
- Equipment and automatization: practical aspects of implementation and operation
Invited experts:
- Yuriy Sandler, Executive Director in CIS countries, PQE
- Tatyana Vyazmina, Quality Director, R-Pharm
- Tatiana Lebedeva, Business Manager, Gluvex
- Dmitry Polstyanov, General Manger, X-tech
- Oxana Pryanichnikova, Development manager, Heuft Eurasia, representative of ISPE, Eurasia
- Yuriy Belykh, product specialist, Agilent Technologies LLC, Russia
- Аnna Plemyashova, Corporate strategy and development director, Beltel
- Konstantin Koshechkin, Head of the informatization Department, Russian Ministry of health
- Igor Falkovskyi, Head of Good Engineer Practice, SED and GP
Jointly with SED & GP and PharmaPharm