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ALL-RUSSIAN GMP CONFERENCE with International Participation

ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

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Page 1: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

ALL-RUSSIAN GMP CONFERENCE with International Participation

Page 2: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

About the Conference The All-Russian GMP Conference with

International Participation is a unique project of the

Ministry of Industry and Trade of the Russian

Federation and Federal State Institution ‘State

Institute of Drugs and Good Practices’ integrating

the professional expertise of leading experts in the

pharmaceutical industry on the pressing problems

of the industry concerning compliance with the

good manufacturing practice standards.

Page 3: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

About the Conference The objective is to create an open forum to share experience and discuss the practical issues arising when implementing

the good practice rules between the Russian pharmaceutical market participants, public authorities, and professional

associations and communities

Goals:

Ensuring maximum openness and transparency with regard to requirements of good manufacturing practices,

applied aspects of their implementation, and peculiarities of preparations for conformity inspection of the

requirements

Facilitating implementation of good manufacturing practice standards by Russian pharmaceutical companies

Contributing to higher levels of fair competition in the industry, stronger investment appeal of the regions, better

provision of the Russian population with high-quality medicines

Facilitating experience sharing in the area of good manufacturing practices between the Russian and international

pharmaceutical companies

Page 4: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

General Information

Participant categories

% of the total*

Representatives of Russian and international regulatory authorities

and agencies (speakers) 6.28%

Company executives (top managers and their deputies, deputies for

quality assurance, production directors, executive directors, Vice

Presidents) 35.36%

Quality control specialists (at various levels) 24.69%

Registration specialists (at various levels) 9.83%

Company representatives for regulatory matters 3.35%

Engineers and production technicians 5.44%

Production specialists 3.56%

Business development specialists 3.14%

Representatives of professional associations 3.14%

Employees of laboratories and research departments 2.93%

Other (HR, sales, PR, etc.) 2.30%

Audience structure Geography and number of participants

2016 – Yaroslavl

Over 70 entities

Over 350 participants

2017 – Gelendzhik

Over 155 entities

Over 800 participants

Over 40 international participants

2018 – Kazan

Over 470 entities

Over 1,000 participants

Over 70 international participants

Country delegations: Russia, USA, Austria, Spain, Croatia,

Japan, Switzerland, Italy, Poland, Hungary, Romania, Mexico,

UK, Cuba, Bulgaria, Kazakhstan, Kyrgyzstan, Germany,

Brazil, Slovenia, etc. * Varies by year

Page 5: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Organizers Organizers:

Ministry of Industry and Trade of the Russian Federation

Federal State Institution ‘State Institute of Drugs and

Good Practices’

Operator:

S-GROUP Corporate Communication Center Limited

Liability Company

Page 7: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

2018 Conference Programme Subject: ‘Russia and the World: Managing the Pharmaceutical Market Growth Potential’

27 AUGUST – REGULATORY DAY

10:00 a.m. – 11:00 a.m. OPENING OF THE 3rd ALL-RUSSIAN GMP CONFERENCE.

Execution of the cooperation agreement between Federal State Institution ‘State Institute of Drugs and Good Practices’ and Federal State Budgetary

Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation

11:15 a.m. – 12:45 a.m. ‘Pharmaceutical Market Growth Drivers: A Global View’

2:00 p.m. – 4:00 p.m. ‘Pharmaceutical Industry of the Future: Government and Business Perspective’

2:00 p.m. – 4:00 p.m. Roundtable on Pharmacovigilance

4:30 p.m. – 6:30 p.m. ‘Present-Day Regulatory System: New Trends and Interaction Formats’

4:30 p.m. – 6:30 p.m. Roundtable of the Council for Professional Qualifications in the pharmaceutical industry ‘Talent Development System for Industrial

Pharmacy’

28 AUGUST – INTERNATIONAL DAY

9:00 a.m. – 9:30 a.m. OPENING OF CONFERENCE DAY 2

9:30 a.m. – 12:00 p.m. ‘Effective Use Of Resources and International Cooperation in the Area of GMP. Mutual Recognition’

10:00 a.m. – 12:00 p.m. Plenary session: ‘The Republic of Tatarstan: An Investment-Attractive Region for the Pharmaceutical Industry’

12:20 p.m. – 2:00 p.m. ‘New Emphases in the EAEU Member States’ Regulation System in Terms of the Good Manufacturing Practice’

3:00 p.m. – 4:30 p.m. ‘Global Experience in Implementing Medicine Markings for Medical Use’

5:00 p.m. – 6:30 p.m. Overview of GEP Trends. Discussion by International Society for Pharmaceutical Engineering of the Eurasian Economic Union

6:30 p.m. – 7:00 p.m. OFFICIAL CLOSURE OF THE 3rd ALL-RUSSIAN GMP CONFERENCE

29 AUGUST – DAY OF BEST PRACTICES

9:00 a.m. – 11:30 a.m. Master class on GMP inspection

12:00 p.m. – 2:00 p.m. Master class on regulating the manufacturing of certain pharmaceutical groups (radiopharmaceuticals, blood products)

3:00 p.m. – 5:00 p.m. Master class on data integrity

Page 8: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

2018 Keynote Speakers

Viktor Evtukhov,

State Secretary, Deputy Minister of

Industry and Trade of the Russian

Federation

Dmitry Mezentsev

Member of the Federation Council

of the Russian Federation,

Chairman of the Committee for

Economic Policy of the Federation

Council

Valery Koreshkov,

Member of the Board (Minister) for

Technical Regulation of the Eurasian

Economic Commission

Arsalan Tsyndymeev,

Assistant Minister of Health of the

Russian Federation

Page 9: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

2018 Keynote Speakers

Albert Karimov,

Minister of Industry and Trade of

the Republic of Tatarstan

Valentina Kosenko,

Deputy Head of the Federal Service

for Surveillance in Healthcare of the

Russian Federation

Aleksey Alekhin,

Director of the Department of

Pharmaceutical and Medical

Industry Development, Ministry of

Industry and Trade of the Russian

Federation

Vladislav Shestakov,

Director of Federal State Institution

‘State Institute of Drugs and Good

Practices’ of the Ministry of Industry

and Trade of the Russian

Federation

Page 10: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

2018 Keynote Speakers

Pär Tellner,

Director, Regulatory Affairs and

Drug Development and

Manufacturing, EFPIA

Shingou Sakurai,

Senior Director for Manufacturing,

Quality, and Compliance, PMDA

Nurlybek Asylbekov,

Deputy Chairman of the Committee

of Pharmacy, Ministry of Healthcare

of the Republic of Kazakhstan

Roberto Conocchia,

Chief Research Administrator,

Manufacturing and Quality

Conformance, Committees and

Inspections Department,

EMA (European Medicines Agency)

Page 11: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

2018 Keynote Speakers

Bogdan Kirillov, Executive Director

of Bulgarian Drug Agency

Vladimir Shipkov,

Executive Director of the

Association of International

Pharmaceutical Manufacturers

Izabela Majic

Head of HALMED inspectorate

(Croatia)

Igor Narkevich,

Rector of St. Petersburg State

Chemical Pharmaceutical

University

Page 12: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Programme of Interactive Events Pre-conference Focus Day with conference speakers and moderators

Tour of the exposition

Press scrums

Execution of the cooperation agreements between Federal State Institution ‘State Institute of Drugs and Good

Practices’ and Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’

Video conference during the meeting of the Working Group for Pharmaceutical Inspection under the Eurasian

Economic Commission

Video conference with Domenico di Giorgio (AIFA, Italy) during the session devoted to markings

Voting at the end of Conference Day 2 and during the master class on GMP inspection

Online broadcast of the sessions at www.gmpnews.ru

Online broadcast of the business programme sessions in the lobby and adjacent hall

Meeting between the representatives of 10 inspectorates and representative of the European Medicines Agency

authorised to oversee the circulation of medicines of the countries exporting pharmaceuticals to the Russian

Federation

Practice master classes

Operation of the conference area

Interviews with conference participants

Selection of the venue for the 4th All-Russian GMP Conference on the map of Russia

Photo session for the conference participants (photo booth)

Page 13: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Exhibition Exposition of companies of the Republic of

Tatarstan:

1. PharmMedPolis of the Republic of Tatarstan

2. Kazan Federal University

3. Kazan Medical University

4. Tatchempharmpreparaty

5. Nanopharma Development

6. Kazan Extracts Plant

7. Kazan Medical Instruments Plant

8. Kazan Electrotechnical Plant

9. Endomedium

10. Medtekhnika

11. Pozis Plant

International companies:

1. Testo

2. Erweka

Page 14: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Conference Website: www.gosgmp.ru Website sections:

For participants

• GMP inspectorate: Q&A

• Terms of participation in the conference

• Special offers of infrastructure facilities

Programme

Speakers (speakers’ short bios)

Partners (conference partners’ profiles)

Archive (conference materials by year)

Media

• Media accreditation form

• Highlights

• Information partners’ details

• Photos

Materials (speakers’ presentations)

Banner space

Statistics (as of August 2018): visits – 10,313, guests – 5,144, views – 27,953, visit depth – 2.71, time spent on the website – 3:33

Page 15: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Information Campaign

As part of the PR campaign, the GMP Conference published over 160 materials in the media, including

trade, regional, and federal media, dedicated groups in social media, information projects aimed at

supporting and promoting Russian pharmaceutical and medical manufacturers.

Information partners:

Farmatsevtichesky Vestnik and Farmvestnik-TV

GMP News

Vademecum

Farmatsevticheskaya Otrasl

Farmatsevticheskaya Promyshlennost

Argumenty i Fakty Kazan

Izvestia Tatarstana

www.pharmmedexpo.ru, фарммедпром.рф, etc.

Page 16: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Advertising Campaign Information desk at the airport

Online banners on information partners’ resources

Advertising modules in trade magazines

Video report on the conference results at Farmvestnik-TV

Static and interactive screensavers

Decoration of the site with advertising structures

Page 17: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Advertising Campaign All conference participants received:

conference programme

candies

stickers

book by V.N. Shestakov

participant certificate at the end of 3 days

Speakers and partners:

backpack

folding umbrella

T-shirt

pocketbook

pen

stickers

Information partners, media, volunteers:

bag

T-shirt

pocketbook and pen

stickers

Page 18: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 19: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 20: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 21: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 22: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 23: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 24: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 25: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 26: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 27: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 28: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Photos

Page 29: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

2018 Results In 2018, the conference took place in the hospitable capital of Tatarstan

Kazan. The site accommodated over 1,000 participants, which is a record-

high number of participants throughout the entire life of the conference to

date.

Printed media representatives showed great interest in the event: about

40 accredited media, over 15 information partners, including trade and

federal media. Furthermore, the conference received support from all

leading trade associations.

This year, the GMP Conference acquired its symbol that turned into a true

rolling trophy. It was passed by the Krasnodar Territory to the Republic of

Tatarstan, and in the future, it will be officially handed over to the heads of

the regions in every new locality wherever the event is held. The venue of

the 4th All-Russian GMP Conference was selected by the participants.

In 2019, the conference will be held in Svetlogorsk, Kaliningrad Region.

Page 30: ALL-RUSSIAN GMP CONFERENCE with International Participationgosgmp.ru/download/Materialy/GMP-conference-2018-summary.pdf · The All-Russian GMP Conference with International Participation

Contacts Business Programme

Federal State Institution ‘State Institute of Drugs and Good Practices’

Contact: Maria Gracheva

Deputy Head of Development Efficiency Department

Tel.: +7 (495) 676-43-60

[email protected]

[email protected]

GMP Conference Operator:

S-GROUP Corporate Communication Center LLC (Moscow)

Contact: Inna Semenova

Tel.: + 7 (495) 120-53-33

[email protected]