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18TH, 19THand 20TH of September 2017, Gelendzhik

“GMP-integration as a driver of the competitiveness
of the pharmaceutical market”


 

Program of the Conference (September 18th-19th)

September 18th, First day

Venue: Gelendzhik, St. Revolutsionnaya 53, Kempinski Grand Hotel Gelendzhik

09:00 – 12:00. Registration of the participants, welcome coffee.

12:00 – 13:00. OPENING CEREMONY

“Renaissance” Hall

Moderator: Head of the Federal State Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation VladislavShestakov

Invited speakers*:

·         Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb

·         Deputy Head of Administration, Deputy Governor of the Krasnodar Region SergeyAltukhov

·         Head of the Department of Drug Supply and Regulation of Medical Devices of the Ministry of Health of the Russian Federation Elena Maksimkina

·         General Director of FSBI "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian FederationYuriyOlefir

·         First Vice-Rector of the Federal State Autonomous Educational Institution of Higher Education “The First Moscow State Medical University named after I.M. Sechenov” of the Ministry of Health of the Russian Federation Andrey Svistunov

·         Head of the Department for the Organization of State Control of the Quality of Medical Products of the Federal Service for Supervision in the Sphere of Health Care of the Russian Federation Valentina Kosenko

·         Head of the municipality of the resort-city GelendzhikViktor Khrestin

PLENARY SESIONS

“Renaissance” Hall

13:00 – 14:00. Issues of industry regulation on the example of pharmaceutical productionlocalization. Factors of developmentand regulatory obstacles

Invited speakers*:

·         Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb

·         Deputy Head of Administration, Deputy Governor of the Krasnodar Region Sergey Altukhov

·         Head of Department for Science, Industrial Policy and Entrepreneurship of Moscow Aleksey Fursin

·         Managing Director of Kaluga pharmaceutical cluster Irina Novikova

·         General Director of JSC PHARMSTANDARD GrigoriyPotapov

·         President of CJSC ACTIVE COMPONENT Alexander Semenov

·         General Director of LLC AMGEN Oleg Paroshin

·         General Director of UAB PHARM-CENTER Managing company OJSC SYNTHESIS Andrey Zagorskiy

14:00- 15:00 Lunch

15:00 – 16:00. EAEU countries integration into the international pharmaceutical system. PIC/S entry issues: main challenges, expected results

 

Board Chairman of Association of Pharmaceutica

Invited speakers*:

·         Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb

·         Head of the Department of Drug Supply and Regulation of Medical Devices of the Ministry of Health of the Russian Federation Elena Maksimkina

·         Head of the Coordination Department in the field of circulation of drugs and medical products of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission Dmitry Rozhdestvenskiy

 

PANEL DISCUSSIONS

“Versailles” Hall

16:00 – 18:00. GMP: inspection. EAEU GMP certificates mutual recognition mechanisms and support measures

“Versailles”- Hall AB

·         Regulators approaches for theinspections, the specifics of the inspection

·         Current issues of mutual recognition, pros and cons of the ongoing framework

·         Necessary supporting measures of mutual recognition of the inspections’ results

·         Features of foreign sites inspections in the context of mutual recognition

·         Analysis of the main non-conformities identified during foreign sites` inspections: classification and categorization

·         Other countries experience of on mutual recognition of GMP-certificates

Moderator: Head of the Federal State Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation VladislavShestakov

Invited speakers*:

·         Deputy Directorof the Department of the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation Elena Denisova

·         Head of Implementation and Development of Good Pharmaceutical Practices and International Standards Department of the «National Center for Expertise of Medicines, Medical Devices and Medical Equipment» of the Ministry of Health of the Republic of Kazakhstan Elena Stepkina

·         Head of Department of Medicines Production Inspecting of the FSI “SID &GP” Natalia Chadova

·         Head of the Department of Pharmaceutical Inspection of the Ministry of Health of the Republic of Belarus Elena Alexandrova

·         Head of the Coordination Department in the field of circulation of drugs and medical products of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission Dmitry Rozhdestvenskiy

·         Head of Pharmaceutical Inspection and Enforcement Department, Spanish Agency for Medicines and Medical Devices (AEMPS) BelénEscribano

·         Assistant Professor. Director, Regulatory Affairs, School of Medicine and Health Sciences - The George Washington University, USA Daniela Drago

16:00 – 18:00. GMP: Next generation factories. GEP global trends

“Versailles”- Hall C

·         Future pharma trends. Objectives and prognosis

·         Continuous manufacturing. Main directions

·         Biotechnology design. Trends and challenges

·         Batch release: European countries` way. Experience, problems, solutions

·         Data Integrity. Basic moments, implementation roadmap

·         High-potential substances and design of production sites based on risk management

 

Moderator:President of International Society for Pharmaceutical Engineering EAEU AleksanderSharonov

Invited speakers*:

·         Vice President European Operations International Society for Pharmaceutical Engineering Tomas Zimmer

·         Head Global Regulatory Management, Merck KGaANajibSehat

·         President Fedegari.comGiuseppe Fedegari

·         Country Manager GEA Russia, Kazakhstan, BY, Central Asia & Caucasus region Oliver Cescotti

·         Head of the FSI “SID & GP” GEP Centre Igor Falkovskiy

·         General Director LLC UNICA INGENEERING Oleg Malakhov

·         General Director PHARMA GROUP BALTIC Dmitry Voloshin

·         Managing Director CJSC BIOCOM Alexander Sergeev

·         Director of Department of Quality and Education FAVEA GROUP Zdenek Pavelek

20:00 – 22:00. Gala dinner

 

September 19th, Second day

8:30-9:00 Welcome coffee

PLENARY SESSION

“Versailles”, Hall ABC

9:00 – 9:30. Opening ceremony of the Second day of the Conference

·         Questions raised on the First day of the Conference.

·         Plan for the second day of the Conference.

Moderator: Head of the Federal State Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation VladislavShestakov

09:30-09:45Presentation of the book “What is good and what is bad in pharmaceutical production”

Authors:VladislavShestakov and YuriyPodpruzhnikov.

09:45. – 10:00 Presentation of Winner of First Russian Interuniversity GxP Summit “Choice of the Best. Time Forward” Armen Mezhlumyan

PLENARY SESSIONS

“Versailles”, Hall ABC

10:00-11:00 International regulatory practice from the perspective of the market players

·         Approaches to the organization of GMP-inspection in the European Union, the USA, the BRICS countries

·         International experience in forming approaches to the unification of GMP, conformity assessment mechanisms

·         Classification and categorization of nonconformities - a review of international regulatory practice and experience

·         Industry position and perspectives

Invited speakers*:

·         Head of Inspectorate Agency for medicinal products and medical devices of Croatia Izabela Majić

·         Coordinator of International Cooperation Agencia Nacional de Vigilancia Sanitaria (ANVISA, Brazil) Lilian Fernandes da Cunha,  GMP Inspector of Pharmaceutical Products Agencia Nacional de Vigilancia Sanitaria (ANVISA, Brazil) Marcelo Sidi Garcia

·         VP Quality Assurance Established Pharmaceuticals,Abbott, Yvonne French

·         Vice President, Quality and Regulatory Compliance NovoNordisk, Former Associate Director for Policy and Regulation US FDA Andrew Chang

·         Assistant Professor. Director, Regulatory Affairs, School of Medicine and Health Sciences - The George Washington University, USA Daniela Drago

11:00-12:00 Drug labeling. Implementation, functionality, registration procedure

Moderators: Executive Director of Professional Pharmaceutical Companies Association Lilia Titova

Head of the Department for the Organization of State Control of the Quality of Medical Products of the Federal Service for Supervision in the Sphere of Health Care of the Russian Federation Valentina Kosenko

·         The main functionality of the drug labeling system

·         Introduction of the labeling process into the pharmaceutical production and drugs circulation

·         Procedure for drugs specification

·         Procedure for drugs registration: step-by-step instructions, possible problems and ways to solve them

 

 

 

Invited speakers*:

·         Head of the Department for Control of Goods Turnover Control of the Federal Tax Service of Russia Olga Chepurina

·         Director for Economics of JSC «R-Pharm» Alexander Bykov

·         Director for economic security of the GC GEROFARM Andrey Akhantiev

·         Director of the Department of External Relations of OJSC NIZHPHARM (STADA Group of Companies) IvanGlushkov.

·         Deputy General Director of GC PROTEK Nikolay Polyansky

12:00 – 13:00. Lunch

13:00-15:00. Pharmacovigilance. New approaches, relevant solutions

Moderator: Deputy Director General in Scientific Work of the “Scientific Center for Expert Evaluation of Medical Products” of the Ministry of Health of the Russian Federation Boris Romanov

·         Regulators` approaches.

·         Drugs Designers` approaches.

·         Marketing authorizations’ holders approach.

Invited speakers*:

·         Adviser to the Head of the Federal Service for Surveillance in Healthcare MariyaChurilova

·         Senior specialist of Drugs Safety Department JSC R-PHARM Roman Zhuravlev

·         Quality and Corporate Development Director of FLEX DATABASES Olga Loginovskaya

·         Director of ANCO NSC OF PHARMACOVIGILANCEAnatoliyKrashennikov

14.00 – 16.00. – Opportunities of new markets. Strategic dialogue.

Open discussion with representatives from Arabic Region

Moderator:General Director of MAM International Health for you, Development Director “Al KenzPharmaceutical Prod. L.L.C” VictoriaKurzantseva (United Arab Emirates)

Invited speakers*:

·         Deputy Minister of Health of the Syrian Arab Republic Habib Abboud

·         Head of Scientific Council for Ministry of Health of Syrian Arab Republic ZuherFadlul

·         CEO “Maatuk Pharma and Unipharma” ImadMaatouk

·         CEO “Ultramedica” Feras Adam

·         Acting General Director of the Federal State Unitary Enterprise "NPO" MICROGEN "of the Ministry of Health of Russia KyrillGaydash

·         General Director of LLC SAN PHARMA RussiaArturValiev

·         Managing Director of GC MARATHON PHARMA Igor Krylov

·         President of CJSC ACTIVE COMPONENT Alexander Semenov

·         Vice-president of PJSC "FARMIMEX" Inga Nizharadze

·         Member of the board of directors of PJSC "FARMIMEX" Maxim Tkachenko

 

WORKSHOPS (3 PARALLEL SECTIONS)

September, 20th, Third day

1.       WORKSHOPS FOR LEADERS

“Versailles”, Hall A

COMPANIES` STRATEGY AND PRACTICE IN THE CONTEXT OF UNIFIED EAEU PHARMACEUTICAL MARKET

9:00 – 09:30. Registration of the participants

Moderator:Deputy Head of the Boardof Medicines Production Inspecting and Expertise of the FSI “SID & GP” Tatyana Nikolko

9:30 – 10:00. Competitive environment. EAEU market estimation

Head of the Economic and Analysis of pharmaceutical and medical production Department of FSI “SID & GP” Stanislav Livanskiy

10:00 – 10:30. Harmonization of domestic production standards with foreign standards: best practice on the VEROPHARMexample

Quality Director OJSC VEROPHARM Andrey Zheltvay

10:30-11:00 Change Management in a Pharmaceutical company

Quality Director GC GEROPHARM Irina Nikitina

11:00-11:20. Coffee - break

11:20 – 13:00. Instruments and tactical actions of companies in the conditions of unified EAEU pharmaceutical market

Head of the Coordination Department in the field of circulation of drugs and medical products of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission Dmitry Rozhdestvenskiy

13:00-14:00. Lunch

14:00 – 16:30. Business Workshop. Strategies and Tactics of the Company's Development

Business trainer, Support Partners company Founder (Top executives recruitment) Konstantin Borisov

16:30-17:00. Closing

2.       WORKSHOPS FOR HR

“Versailles”, Hall B

GMP IN THE PERSPECTIVE OF PHARMACEUTICAL PERSONNEL TRAINING AND DEVELOPMENT. BEST PRACTICES

9:00-9:30. Registration of the participants

Moderator:Director of the Institute of Pharmacy and Translational Medicine of the Federal State Autonomous Educational Institution of Higher Education “The First Moscow State Medical University named after I.M. Sechenov” of the Ministry of Health of the Russian Federation Vadim Tarasov

9:30 – 10:00. Pharmaceutical production personnel training. Personnelqualification development (presentation of the research)

Head of Department of External Communications of FSI “SID&GP” Anna Plesovskikh

10:00 – 10:30. Artificial intelligence. New technologies in personnel training.

Director of corporate strategy and development of JSC «Beltel» Anna Plemyashova

10:30 – 11:00. Development and implementation of the development strategy of personnel based on the example of the company

HR Director, pharmaceutical company

11:00-11:20. Coffee – break

11:20 - 11:50. System of independent assessment of qualified specialists in the pharmaceutical industry

Member of the Council of the SEC in the field of pharmacy, Head of the Department of "Industrial Pharmacy" of the Institute of Pharmacy and Translational Medicine of the Federal State Autonomous Educational Institution of Higher Education “The First Moscow State Medical University named after I.M. Sechenov” of the  Ministry of Health of the Russian Federation Natalia Pyatigorskaya

11:50 - 12:20. "Training of personnel in the context of the" Pharma-2020 "strategy

Head of the Department of Pharmaceutical Technology, Faculty of Professional Development of Medical Workers of the Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia" (PFUR)RimmaAbramovich

12:20 – 13:00. GxP for HR. Introduction

Manager for quality assurance of LLC “ISAIRUSSIA” Sofia Mukhina

13:00-14:00. Lunch

14:00 – 16:30. Review seminar "Technologies of full-time education"

Founder and General Director of the consulting company "Pharm Galactica", Stanislav Ovchinnikov

16:30-17:00. Closing

3.       WORKSHOPS FOR THE RESPONSIBLE PERSONNEL

“Versailles”, Hall C

MODELING OF THE INSPECTION

9:00-9:30. Registration of the participants

Moderator:Head of Department of Medicines Production Inspecting of the FSI “SID & GP” Natalia Chadova

09:30 – 9:50. Key trends analysis of inspections based on the results of inspections conducted in the period 2016- first half 2017

Head of Department of Medicines Production Inspecting of the FSI “SID and GP” Natalia Chadova

9:50-11:00.Business training. Classification of modeling non-conformities

Deputy Head of Educational Center of the FSI “SID & GP” Vladimir Orlov

11:00-11:20. Coffee – break

11:20 – 12:00. Data integrity

Quality Director JSC R-PHARM Tatiana Viazmina

12:00 - 12:30. GMP certification: international and Russian experience. A look from both sides

Quality Director OJSC "CHEMICAL-PHARMACEUTICAL FACTORY “AKRIKHIN” Olga Maklakova

12:30-13:00 Inspection-final exam or formal pass-fail?

Head of validation group of OJSC VEROPHARM M. Pavlov

13:00-14:00. Lunch

14:00 – 16:30 Workshop. GMP for Advanced Therapy Medicinal Products – Key Elements of the Draft Guidelines from the European Commission

General Manager PMS Process Management System and Trainer for Educational Pharma Programs at ARIAQ (Switzerland)StéphaneGumy

16:30-17:00. Closing

 

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