III Всероссийская GMP-конференция | Materials of the conference
Materials of the conference
Day first, September 18th
Localization of production (13.00-14.00)


Altukhov S. – Pharmaceutical manufacture Moscow


Kukava V. – Biopharmaceutical Competitiveness


Novikova I. – Localization of pharmaceutical production


Semenov A. – Regulating the industry


Fursin A. – Pharmaceutical manufacture of Moscow


Tsyb S. – Overview of the pharmaceutical market

Integration into the international system (15.00-16.00)


Rozhdestvenskij D. – GMP Eurasian Union as a basis for the regulation of the production and study of drugs

GMP inspection. The mutual recognition (16.00-18.00)


Belen Escribano – Mutual recognition


Daniela Drago – Strengthening Regulatory Systems


Aleksandrova E. – Implementation of requirements for pharmaceutical inspectorates of member States of the EAEU International cooperation


Dezhemesova A. – Modern state of the pharmaceutical industry


Rozhdestvenskij D. – GMP Eurasian Union. The recognition of inspections and submission of the registration dossier


Stepkina E. – problems of harmonization of national standards with international requirements and GxP practices. Experience in the assessment of the conditions of production


Chadova N. – Analysis of key trends on the results of inspection of foreign manufacturers of medicines for 2016-2017

Factories of the future (16.00-18.00)


Giuseppe Fedegari – Delivering Cost-effective Unconventional Solutions for the Global BioPharmaceutical Industry


Oskar Goldstein – Current Status Continuous Manufacturing


Tomas Zimmer – Factories and plants


Voloshin D. – Pharmaceutical plant Pharma Group Baltic


Zdeněk Pavelek – Principles and tools to ensure data integrity


Malakhov O. – the Current needs of the pharmaceutical market of the Russian Federation in the engineering services


Sergeyev A. – Pharmaceutical plant JSC «Biocom»


Falkovsky I. – Pharmaceutical manufacturing

Area of business contacts


Andrew Chang – Introduction and Case Sharing of FDA CGMP Inspections

Day second, September 19th


Mejlumian A. – Comparative analysis of requirements to the composition of the registration dossier for the medicinal product

International practice (10.00-11.00)


Belen Escribano – GMP Inspections


Daniela Drago – Compliance is not equal to Quality


Yvonne French – DVP QA_Industry trends


Isabella Magic – HALMED accession to PICS and GMP inspections outside


Andrew Chang – US-EU Mutual Reliance Agreement on cGMP Inspections

Marking (11.00-12.00)


Ahantiev A. – Experience in the implementation of the labeling process


Bykov A. – Traffic monitoring System


Glushkov I. – The Introduction of an automated system of monitoring the movement of drugs


Kosenko V. – On realization in Russian Federation of the experiment in the marking of control (identification) sign


Maltsev V. – Implementation of a priority project for the labelling of medicines in the Russian Federation


Polyanskiy N. – Project Branding

Pharmacovigilance (13.00-14.00)


Zhuravlev R. – Organization of pharmacovigilance


Kosenko V. – legal requirements for pharmacovigilance


Krasheninnikov E. – System of spontaneous messages in Russia


Loginovskaya O. – Automation pharmacovigilance


Romanov B. – Pharmacovigilance

Strategic dialogue (15.00-16.00)


Apazov A. – PJSC «Pharmimeks»

Day third, September 20th
Hall «А»


Borisov K. – Business training


Zheltvay A. – Harmonization of domestic standards of production with foreign best practice examples


Livanskij S. – Evaluation of the EEU market


Nikitina I. – Change Management in pharmaceutical companies


Rozhdestvenskij D. – Single market of medicines in the EEU

Hall «B»


Mukhina S. – GxPs for HR. Introduction


Plemyashova A. – Artificial intelligence. New technology in personnel training


Plesovskikh A. – Training of staff in the pharmaceutical production. The training of employees


Abramovich R. – Training in the context of the strategy «Pharma-2020»


Ovchinnikov S. – Technology full-time education


Pyatigorskaya N. – A system of independent assessment of qualification of specialists of the pharmaceutical industry

Hall «C»


Vyazmina T. – Data Integrity Data Integrity


Maklakova O. – Certification in accordance with GMP international and Russian experience. The view from two sides


Orlov V. – Business workshop classification inconsistencies identified for the results of a GMP inspection auditing


Pavlov M. – Inspection and audit


Chadova N. – Analysis of key trends on the results of inspection of foreign manufacturers of medicines for 2016-2017

Video
The speech by John Burnas, President of ISPE
II Russian GMP-conference. Review
Kosenko V. – On realization in Russian Federation of the experiment in the marking of the control (identification) signs
Glushkov I. – The Introduction of an automated system of monitoring the movement of drugs