Career and skills:

Elena Denisova has the experience and knowledge in the areas of registration and reregistration of foreign and domestic medicines, and inspecting of medicines manufacturers on compliance with GMP requirements. She has a certificate of GMP Inspector, issued by WHO.

From January 2014 Elena Vladimirovna had been in charge of Division for medicines manufacturing licensing of the Department for pharmaceutical and medical industry development.

In May 2017 she was appointed the Deputy Director of the Department for pharmaceutical and medical industry development of Minpromtorg of Russia.

Almost 9 years Elena Denisova was working in Roszdravnadzor, where, as well, she was in charge of medicines registration area.

Her general experience in pharmaceutical field is 20 years, including employment in major companies.

Education:

Lomonosov Moscow State University, Candidate of Chemical Sciences, Production management, MBA – production management, qualification upgrade in GMP/GDP Inspection/Audit.

Career:

In 1997 moved from Scientific Laboratory to the production. During 9 years she was working at Moshimpharmpreparaty, From workshop technologist to Deputy General Director for Production and Technical Affairs. March 2006 – July 2010 – CJSC «Binnopharm» («MTH»), Management of realization of pharmaceutical production construction (including vaccines) from the concept stage. October 2010 – October 2015 – CJSC «PharMedica» (Engineering Company). From October 2015 – Head of Pharmaceutical Production Inspection Department.

Education:

Saint-Petersburg State Chemical-Pharmaceutical Academy. Additional trainings in a field GMP/GDP-inspection/audit; GMP-Inspector.

Career:

His career was started at the enterprise on the manufacture of active pharmaceutical ingredients. Since 2008 to 2013 worked at STATE RESEARCH INSTITUTE OF HIGHLY PURE BIOPHARMACEUTICALS (Saint Petersburg) as Validation Engineer. In 2013-2014 worked in the city of Kaluga during the launch phase of asite to produce insulin «Novo Nordisk», where he was engaged in manufacturing of aseptic and sterile production. Since 2014 began work in the newly created Department of inspection of the FSI «SID and GP» as the leading expert-auditor. November 2016 was to combine the primary activity with the position of the Head of the laboratory of GMP of the Education Centre of the FSI «SID and GP».

Education and career:

Roman Loretts is regional manager for Central and Eastern Europe at ELLAB A/S (Denmark). With his background of radio engineer and interpreter, Roman had been employed within last years as Senior Adviser at the Trade Council of Denmark in Russia, being part of the Ministry of Foreign Affairs of Denmark. Since 2011, Roman has led the support and development of cooperation of ELLAB in the countries of Central and Eastern Europe, Italy, Turkey, Russia and CIS countries. ELLAB validation solutions are well known to the industry specialists all over the world and have the highest reputation. Roman’s responsibilities include interaction with distributors and key account customers, training seminars for specialists, localization and registration of ELLAB products.

Education:

High School: HAVO, graduated 1981, Atheneum, graduated 1983

University: University of Delft; Mechanical Engineering 1983–1988

Trainee at Volvo Cars in Sweden for three months

Masters in Vehicle Dynamics at Daf Trucks Eindhoven

Career:

Stork Bronswerk Amersfoort 1989-1991. Designing, manufacturing and installing cold storage systems for Stork Meat Processing Group. Function: Sales Support – Project Manager.

Calumatic B.V. Dongen 1991–1994. Privately owned supplier for low and high speed, LVP and SVP, aseptic filling lines including vials washing machines, sterilization tunnels. First to introduce high speed “Time – Pressure” and “Net – Weight” vial filling machines in the market. Stoppering and capping equipment. Function: Area Sales Manager for Scandinavia, Poland, Hungary, Czech and Slovak Republic, working in close cooperation with several agents.

BOC Edwards Pharmaceutical Systems B.V. Dongen 1994–mid 1999. BOC Edwards Freeze Drying acquired Calumatic B.V. including industrial type freeze dryers in the program and developing a full range of automatic loading systems. Function: Area sales manager for the full product range i.e. aseptic filling lines, industrial freeze dryers as well as auto loading systems for the same area (as above) including the Netherlands.

Mid 1999–mid 2002. Transferred with family to the BOC Edwards facility in Tonawanda NY USA on an ex-pat basis for a period of three years responsible for US West-Coast and Mid-West area.

Mid 2002–mid 2004.

Business Manager Pacific: responsible for the integration of the Japanese Pharmaceutical Systems service & sales group: implementing financial control and streamlining equipment specifications, introducing new developments, fine tuning cost estimates, project management, driving the local sales managers and prospects.

Mid 2004–Aug 2007

Business Manager Asian Pacific Region with the main focus on India. Commercial introduction of Edwards, Chinese manufactured Lyofast, a new range of standard industrial freeze dryer. Providing market information and requirements to optimize Lyofast design and specification. Developing of the India market resulting into BOC Edwards being market leader in their segment.

GEA Process Engineering B.V. Aug 2007–July 2015. Area Sales Manager employed by GEA Process Engineering Netherlands, working for GEA Pharma Systems Continuous Processing including GEA Courtoy and GEA Pharma Systems Collette N.V. Global Account Manager GEA Pharma Systems.

July 2015–Today. Sales Support Manager APC Pharma Solids for R&C (Regions & Countries) Eastern Europe, Baltic, Scandinavia, Russia covering all APC Pharm Solids technologies, Continuous OSD manufacturing, classic batch granulation, compression and coating.

In 2010 M.Concetta joined Tecninox, a successful and dynamic company that will challenge her problem solving skills and allow her to continue to develop her knowledge and potential. She ensuring project compliance with company developments concepts and regulation, with GMP rules. Project driving on key contract manufacturing projects, collaborating with cross-functional teams, such as: Quality, Production, Procurement, Planning and Logistic; she can work independently and in a team environment. She has a comprehensive knowledge of pharmaceuticals rules and regulations, and an excellent team spirit, capable of interacting with other discipline engineers.

Education:

Degree in Chemical Engineering in 2000 – University of Naples, «Federico II»: experimental thesis (2006-2007) on «Phenolic Compound Polluted Soils- natural remediation methods».

After the graduation, Ph.D. in Industrial Chemistry Department of University of Naples; research activity for «Methane Autothermic Steam Reforming» 2007–2008.

Career:

Tecninox srl-CHEMICAL ENGINEER: Dec 2010–Present. Documentation and Validation department management Project Manager.

Having direct responsibility to manage the work of Documentation&Validation Department.

Coordinating and Project management of several Tecninox projects;

Baxter Rieti Capacity Expansion Project- Plasma Fractionation: 2012-2013.

Kedrion NGIG Immunoglobulins Project- Plasma derivatives plant: 2014-2015.

Kedrion Pure Fluids Storage and Distribution: 2014-2015.

Merck Sterile Compounding, CIP Skid, COP Station & Filling: 2015-2017.

Merck Pure Fluids Storage and Distribution: 2015-2017.

Rompharm Blow Fill Seal and Freeze Drying Sterile process: 2016-2017.

Sopharma Syrup Preparation Plant: 2017.

Career:

Josef Trapl, Global Head of Technology within the Global Engineering Organization in Takeda Pharmaceuticals International based in Zürich, Switzerland has long term professional project experience serving the Pharma Industry in Engineering & GMP consulting, designing and building capabilities. He is a chartered Chemical Engineer (MChE) with extensive global design and project execution experience across quality and other business areas in the Bio-Pharmaceutical Industry covering Bio-API, Fill&Finish and Oral Solid Dosage (OSD) production. He is with Takeda since 2015 and was parallel acting as regional engineer for Europe/CIS until end of 2016 to support the transformation of the Global Engineering organization and has a Master of Business Administration (MBA) degree from the Mannheim Business School, Germany. In his current corporate role as a technology manager he is responsible for industry trends, new technologies and automation (Pharma/Industry 4.0/IoT), technology transfer, operational excellence and to follow regulatory aspects.

Career:

Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Sales Containment. Mr. Denk founded 8 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the Containment Manual Mr. Denk was responsible for in September 2015. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Education and career:

Sergio Mauri holds a Chemical Engineering degree. He has been involved in cleanroom technologies since 1980 and is currently Manager of the Global Integrated Projects Unit at Fedegari Group, dealing with the design and supply of new solutions for the sterile drug manufacturing including GMP robotics.

His Scientific Technical Association activities include member of the board of the Italian Association of Contamination Control (ASCCA: www.ascca.net) since 1986, President 1998-2000 and currently Vice-President, and ISPE and PDA member since 2001. He is trainer in pharmaceutical HVAC design at La Sapienza University (Roma) for students of chemical and pharmaceutical technology, gives training lectures to AIFA GMP Italian inspectors and is the author of several papers on clean technologies.

Education and career:

With Technical Background as Engineer, Master’s Degree in Project Management, along with his competent and intense work approach to production management in chemical industry and business development management, Sergi Gonzalez has built a progressive career of 17 years as a production plant director first, being responsible for coordinating and developing activities, and then as a sales and product manager mainly orientated to International Markets.

Proven expertise in Asia, Middle East, Latin America, North America, Russia and Europe. Primarily focused on implementing sales opportunities for Industrial Machinery and Pharmaceutical Process Equipment in a bussiness-to-bussiness market.

Currently, Sergi Gonzalez is in charge of establishing large recurrent volume profitable operations in Europe, CIS countries and Israel, being a Sales manager at Dara Pharmaceutical Packaging. He has achieved to enlarge company‘s international projection, increasing its export share and contributing into company‘s value acquisition.

Major achievements: team building, production productivity improvement, sales growth, market analysis and segmentation, international business strategy development.

Education:

University of Chemical Technology of Russia named after Dmitry Mendeleev, Ph.D. in Chemistry.

Career:

Alexandr Sharonov has more than 19 years of experience in pharmaceutical industry. He worked in the top Russian, European and international engineering companies (Chistyi vozduh, Pharmaplan, PharmaGroup, PM Group, ZETA) as an expert and project manager for designing, equipping and qualifying new and reconstructing existing pharmaceutical productions of various types. Member of ISPE since 2007. Specialization – design and engineering in the field of solid dosage forms, sterile and non-sterile liquid medicines, technological design and design of R & D and QC laboratories design.

Skills:

Pharm engineering, Project management, Qualification and validation, Multi-office project execution.

Professional experience:

STENTEKS LLC, Russia, New Construction, Conceptual Design, Stage Project. 25,000 m2. Production – medical products (coronary stents, catheters).

VERTEX, Russia, New construction, Conceptual design, Stage Project. 32,000 m2 Production – Solid dosage forms / Soft dosage forms / liquid non-sterile forms, including sex hormones.

TAKEDA (NIKOMED), New construction, Basic design, Detailed design, Plant for the production of injection solutions and solid dosage forms. Yaroslavl, Russia.

FSUE «Moscow Endocrine Plant», the project – «turnkey». Reconstruction of the workshop for the production of injectable drugs using the BFS method.

«Binnopharm», Conceptual, Basic project, plant for the production of injection solutions, pharmaceutical aerosols and solid dosage forms, Complete reconstruction.

State Research Organic Chemistry and Technology, «turnkey» project, Vivarium for laboratory animals, Complete reconstruction.

«ZIO – Health» Production of Solid dosage forms, New Plant, Russia.

Petrovax Lab, Pilot production of substances for injection, Moscow, Russia.

LLC «Biocom», the project – «turnkey». Production of solid dosage forms, Stavropol, Russia.OOO MAKIZ FARMA, Manufacture of solid dosage forms, Moscow, Russia.

Career:

Boehringer Ingelheim 1981-2013. Pharmaceutical Development, Pharmaceutical Production, International Production- and Quality Management, Quality standards, Extended business stays in Brasil, Spain, USA and Mexico, Corporate lead auditor GMP, Implementation Production Alliance Europe, Product transfers, Transition management from national to international supply, Plant manager / Directeur industriel Pharmaceutical Production in France, SVP Global Quality, Qualified Person, SVP EHS & sustainability.

Since August 2013. ZS.CTIS Consulting GmbH, CEO&Managing Director.

Since Nov. 2013. ISPE VP European Operations.

Education and professional activity:

1998 – UO «Vitebsk State Medical Institute».

1999-2002 – Postgraduate studies, then clinical residency of Vitebsk State Medical University, specialization in Clinical Pharmacology. 2002-2004 – Department of General and Clinical Pharmacology of Vitebsk State Medical University (Republic of Belarus).

2002-2004 – Department of General and Clinical Pharmacology ofVitebsk State Medical University (Republic of Belarus).

2004-2014 – Republican Clinical-Pharmacological Laboratory of the UP «Center for Expertise and Testing in Health Care» (Republic of Belarus).

2014-untill now – Eurasian Economic Commission, Department of Technical Regulation and Accreditation (Russian Federation).

Area of practical interests:

Clinical studies of medicines, biological statistics, clinical pharmacology.

Research work:

Planning, implementation and quality assurance of more than 140 bioequivalence studies of reproduced (generic) medicines in the Republic of Belarus, 30 clinical trials of pharmaceuticals (allergology, cardiology, neurology, ophthalmology) of I and III phases.

Education:

Masaryk University in Brno (Czech Republic), faculty of natural sciences.

Career:

Prior to joining FAVEA, Zdenek worked as a Director of the quality management department at TEVA Czech Industries.

He also previously held the position of Head of Quality Control at Galena.

During his work Zdenek Pavelek has developed a number of author’s training courses and lectures for the training of specialists of pharmaceutical companies in the Czech Republic and other European countries (Slovakia, Poland, Latvia, Lithuania, Germany, Switzerland), as well as Ukraine, Russia, Kazakhstan, China and Brazil. Zdenek also has extensive experience in the validation of analytical methods, validation processes, purification validation, equipment qualification and computer system validation.

Currently, he actively participates in the preparation of pharmaceutical manufacturers of medicines for oficcial controls and audits be EU and US regulators, and also deals with Quality Management of FAVEA projects.

Career:

Vadim Vlasov has been Country President of Novartis Group Russia since September 2010. In this role he is accountable for the local business operations management, interaction with external stakeholders, coordination of Novartis divisions and business units in Russia, the company reputation maintenance and development.

Prior to joining Novartis in 2003-2010 Mr. Vlasov occupied the position of Head of EADS/Airbus in Russia.

Previously, Mr. Vlasov served as Head of Siemens Medical Solutions and Country Manager of Acuson Corporation in Russia and CIS, worked in the Deputy Minister of Defense of the Russian Federation office.

Mr. Vlasov has a Degree of Mechanical Engineer (with honours) from Moscow Aviation Institute and completed Advanced Development Program at London and Harvard Business Schools.

Career:

Alexander has dedicated more than 20 years of his life to development of the Russian pharmaceutical industry. He is member of the coordination council of the Russian Pharmaceutical Marketing Association (RPhMA). Before NovaMedica, Alexander was First Deputy CEO at the Rigla pharmacy chain, one of the largest players on the Russian market. Previously from 2004 to 2009 he headed DSM Group, one of the largest marketing and analytical agencies on Russia’s pharmaceutical market. From 1996 to 2003 Alexander held different positions in marketing and advertising at the pharmaceutical company Protek Group.

Alexander has won on several occasions Platinum Ounce, a national award in the pharmaceutical industry: he received a Press Acknowledgement nomination in 2007, and Functional Manager nomination in 2012. In 2017 NovaMedica under leadership of Alexander Kuzin and in alliance with Pfizer which became NovaMedica’s strategic partner in 2016 was acknowledged as Platinum Ounce winner in the Deal of the year nomination. Alexander was included into the rating “TOP-1000 Russian Managers” of the Association of Russian Managers four times – in 2012, 2013, 2014 and 2017.

Alexander Kuzin graduated in 1996 from Moscow Physical Engineering Institute with a degree in Physical Engineering and obtained MBA degree in 2002.

Education:

State university «Higher School of Economics» in specialization «Economics and Enterprise Management».

Career:

From 1995 has been working in the sphere of health and pharmaceuticals. The founder of the Russian high-technology pharmaceutical company «R-Pharm». Co-chairman for international activity, Member of the General and Coordination Councils, Head of the Committee on Health Protection of Citizens of the All-Russian Public Organization «Delovaya Rossiya». Co-chairman of the RSPP Commission on pharmaceutical and medical industry.

Member of the Economic Council under the President of the Russian Federation. Member of the Expert Council under the Government of the Russian Federation. Member of the Supervisory Board of the Autonomous Non-Profit Organization «Agency of Strategic Initiatives for Promotion of New Projects». Deputy Chairman of the Council for the Development of Biotechnology, Pharmaceutical and Medical Industry under the State Duma Industry Committee. Member of the Public Council of the Ministry of Industry and Trade of the Russian Federation, Head of the Working Group on Pharmaceuticals, Medical Equipment and Technologies. Member of the Coordination Council in the sphere of medicines and medical products circulation under the Ministry of Health of the Russian Federation. Member of the Expert Council of the FAS of Russia on the development of competition in the social sphere and health. Head of the working group on the development of the road map «Establishment of a national system of competencies and qualifications» within the framework of the National Entrepreneurship Initiative to improve the investment climate in Russia. As a member of the Association of Russian Pharmaceutical Manufacturers (ARPhP), promotes the development and competitiveness of the domestic pharmaceutical industry. Alexey Repik was the first of the Russian pharmaceutical companies representatives who was admitted to the AIPM (Association of International Pharmaceutical Manufacturers). Provides active support to educational, social, cultural and sports and recreational projects in Russia. He is awarded by the Letter of appreciation of the President of the Russian Federation, the Letter of appreciation of the Chairman of the Government of the Russian Federation, has awards of subjects of the Russian Federation.

Education and career:

In the early 90s after the completion of his studies at a Military academy in Moscow Dmitry Voloshin has worked as a reporter at the radio station «Radio Europe» in Berlin, Germany. Together with the ifa (Institut für Auslandsbeziehungen) in Stuttgart he organized several business trainings for young Russian managers at the leading German industrial companies. In addition, also in pharmaceutical and medical field such as Schering, Berlin-Chemie AG, Siemens etc. Through his good contacts to big pharmaceutical companies Dmitry Voloshin started to work as an attorney in German-Russian trade company (Novamed GmbH) for finished pharmaceuticals and medical equipment.

In 1995 Mr. Voloshin started as a managing director of Pharmaplan GmbH Moscow office, a leading engineering company specialized in pharmaceutical and biotechnical industries. Since 2001 he became a CEO of its Russian subsidiary «Pharmaplan» LLC.

After company’s acquisition by NNE in 2007 Mr. Voloshin left Pharmaplan and started as a CEO in a new founded Russian engineering company «Pharma Group LLC». Under the management of Mr. Voloshin Pharma Group has grown up from a scratch business to a well-known Russian design and engineering company specializing on turnkey projects for pharmaceutical industries. Among Pharma Group’s customers are leading multinational pharmaceutical companies such as Nycomed-Takeda, Berlin-Chemie AG, AstraZeneca, Teva and also many local pharmaceutical producers.

Since 2013 and up to now Dmitry Voloshin is developing his own business – company «Pharma Group Baltic» as a GMP-consulter and project supervisor. After a short period of time «Pharma Group Baltic» became a reliable partner in several pharmaceutical and medical projects not only in Russia but in abroad.

During 25 years project experience Mr. Voloshin has implemented about 50 pharmaceutical projects also including eleven green field projects in Russia and Eastern Europe.
Mr. Voloshin has in-depth knowledge of international and local construction norms and guidelines as well as pharmaceutical industry. He lectures at various seminars and trainings in Russia, is the author of some articles in Russian journals. Since 2002 Dmitry is a ISPE member. Representing «Pharma Group Baltic» he is one of the foundedrs of «International Society for Pharmaceutical Engineering Eurasian Economic Union».

Education and career:

Dmitry Efimov started his career with Nizhpharm in 1996, joining the company as analyst manager, and made a long way since, assuming different roles in various functions, from marketing to finance.

In 2007, Dmitry Efimov headed Nizhpharm with subsequent appointment to Vice President for Russia and CIS position at STADA AG. Five years later, he was promoted to Senior Vice President rank.

Under his leadership, the company achieved more than ten times’ growth in its Russia sales and successfully implemented its export strategy: Nizhpharm provides for roughly 30% of overall Russia’s medications volume supplied abroad. The company’s produce today is sold in 17 foreign countries. STADA’s production facility in Nizhny Novgorod was the first to undergo GMP Quality certification by EU authorities, and was later awarded with #1 certificate of Russia’s domestic GMP inspection board.

Dmitry Efimov heads Supervisory Board of Association of Russian Pharmaceutical Manufacturers (ARPM).

«TOP-1000 Russia’s Managers» Rating for 2015 and 2016 placed Dmitry Efimov at #1 position among pharmaceutical business leaders.

Additional information:

Dmitry Efimov was born on August 9, 1975, in Nizhny Novgorod. In 1997, he graduated from Economics faculty of Nizhny Novgorod State University named after Nikolay Lobachevski. He also studied in the USA, taking part in the Presidential program, and underwent Dynamic Business Management program training at Netherlands’ de Baak management support center in 2001. In 2007, he earned a PMBA degree at IEDC Bled School of Management (Slovenia).