The Ministry of industry and trade of the Russian Federation

The programme

October 16, Day 1

9:00-10:00 Participants registration, coffee break
10:00–10:30 CONFERENCE OPENING
Moderator: Deputy Head Pharmaceutical Production Inspection and Expertise Administration Tatiana Nikolko

Invited Speakers*:

  • Deputy Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation Elena Denisova
  • Director of FSI “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov

EDUCATIONAL BLOCK

10:00–13:00 Inspection of pharmaceutical production. Regulator’s view
  • Inspection organisation, preparation and conduct
  • Responsibility of the manufacturer and the applicant
  • Analysis of the most frequent nonconformities identified during the inspection process

Moderator: Deputy Head Pharmaceutical Production Inspection and Expertise Administration Tatiana Nikolko

Invited Speakers*:

  • Deputy Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Minpromtorg of Russia Elena Denisova
  • Head of Department of Medicines Production Inspecting of the FSI «SID & GP» Natalia Chadova
  • Deputy Head of Educational Centre of the FSI «SID & GP» Vladimir Orlov
  • Leading Specialist of the Department for Pharmaceutical Production Inspection of FSI «SID & GP» Nadezhda Arkhipova
13:00–14:00 Dinner

EDUCATIONAL BLOCK

14:00–15.00 Review of decisions and trends in the thermal validation market
  • Data loggers and thermopads
  • Validation of steam sterilizers
  • Overview of the newest technological solutions from ELLAB A/ S experience

Invited Expert*: Regional Manager ELLAB A/ S Roman Loretz

15:00–16:15 The concept of continuous production by the example of an implemented project
  • ТContinuous granulation technology
  • Methods of continuous granulation applying
  • Implementation of the concept of continuous production by the example of Pfizer

Invited Expert*: Regional Manager APC Pharma Solids, GEA Process Engineering Oscar Goldstein

16:00–16:15 Coffee break
16:15–18.00 Complex equipment of plants for the processing of blood plasma: production of various products from human blood plasma
  • Blood plasma – world technologies
  • The way from the donor center to factories by fractionation through biological and chemical analysis of the blood plasma
  • The most common methods of fractionation
  • The example of a realised project in accordance with GMP for the plant Kedrion

Invited Expert*: Project Manager TECNinox Srl Maria Concetta Santangelo

October 17, Day 2

9:00-10:00 Welcome coffee break

EDUCATIONAL BLOCK

10:00–11:00 The newest technologies of pharmaceutical production. Investments and Results
  • Automation, modernisation of production facilities, the cutting-edge world-class technologies
  • Evaluation of investment efficiency at the planning stage
  • Successful practices of the world leading manufacturers

Invited Expert*: Head of Global Technologies Department Takeda Pharmaceuticals International AG Joseph Trapl

11:00–12.00 The process of bio-decontamination with hydrogen peroxide vapor and the aseptic transfer of materials sensitive to high temperatures
  • Factors for choosing bio-decontamination of surfaces and available technologies
  • Quality by Design, risk assessment and mitigation actions to have a full control of the surface bio-decontamination process
  • Decontamination cycle and equipment features
  • Validation approach of bio-decontamination

Invited Expert*: Team Leader, Global Integrated Projects Sergio Mauri

12:00–13.00 Advantages of fully servo drive solutions and modular constructions for pharmaceutical equipment
  • Servo drive technologies and modular constructions
  • What is «modules» and what are the advantages of a modular construction
  • What is «servo drive technologies» and their application in modular constructions
  • Key advantages of servo drive technologies
  • Upgrade and modification

Invited Expert*: Regional Sales Manager, Dara Pharmaceutical Packaging Sergi Gonzalez

13:00–14:00 Dinner

PANEL DISCUSSION

14:00–15:00 Program is under development

OFFICIAL PRESENTATION

15:00–16:30 ISPE EAEU Affiliate opening in Russia
  • Cooperation agreements signing
  • Presentation of the global ISPE mission
  • Goals and objectives of the ISPE EAEU Affiliate

Moderator: President of the International Association of Pharmaceutical Engineering of EAEU Alexander Sharonov

Invited Speakers*:

  • Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb
  • Pfizer Vice-President, ISPE Chairman Michael Arnold
  • ISPE Vice President for European Operations Dr. Thomas Zimmer
  • Director of FSI “State Institute of Drugs and Good Practices” of the Minpromtorg of Russia Vladislav Shestakov
  • Head of the Department of Coordination of Work in the Sphere of Drugs and Medical devices circulation of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission Dmitriy Rozhdestvensky
  • General Director of the “National Center for Examination of Medicines, Medical Devices and Medical Equipment” of the Ministry of Health and Social Development of the Republic of Kazakhstan Aygul Shoranova
  • General Director of the Department of Drug Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic Gulmira Shakirova
  • Head of the Department of Pharmaceutical Inspection and Drug Supply Organization of the Ministry of Health of the Republic of Belarus Lyudmila Reutskaya
  • Director of the Quality and Training Department of the FAVEA Group Zdenek Pavelek
16:30–16:45 Coffee break

PANEL DISCUSSION

16:45–18:00 Effective management of pharmaceutical production. Strategic vision of Top Managers
  • Optimization of modern pharmaceutical production processes
  • Key performance indicators, labour productivity
  • Quality control management, automation of production, personnel qualification development

Moderator: Director of FSI «State Institute of Drugs and Good Practices» of the Minpromtorg of Russia Vladislav Shestakov

Invited Speakers*:

  • General Director «R-Pharm» Aleksey Repik
  • General Director «Nizhpharm» (STADA Group) Dmitriy Efimov
  • General Director PHARMA GROUP BALTIC Dmitry Voloshin
  • General Director of NOVAMEDICA Alexander Kuzin
  • General Director of the NOVARTIS GROUP OF COMPANIES Vadim Vlasov
  • General Director of BIOCAD Dmitriy Morozov
  • Director of the Quality and Training Department of the FAVEA Group Zdenek Pavelek
18:00–20:00 Evening reception