Upload
others
View
30
Download
0
Embed Size (px)
Citation preview
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.
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
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
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
2018 Conference Partners General Partner Strategic Partners Partners
Session Partners
Information Partners and Associations
Special Partners
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
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
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
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)
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
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)
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
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
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.
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
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
Photos
Photos
Photos
Photos
Photos
Photos
Photos
Photos
Photos
Photos
Photos
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.
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
GMP Conference Operator:
S-GROUP Corporate Communication Center LLC (Moscow)
Contact: Inna Semenova
Tel.: + 7 (495) 120-53-33