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