The digitalization era and data integrity. The industry view

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