Freelancer consultant – Boneh Consulting, Pharma Engineering
Experienced in pharmaceutical facility engineering including ongoing maintenance and upgrades to ageing facilities, project management, capital expenditure management and GMP compliance.
- 2013 – 2014: Director, Global Engineering – Head of Critical Systems, Teva Pharmaceuticals Ind. Ltd., TGO – Global Operations
- 2007 – 2013: Director, Global Engineering and Capital Expenditure, Teva Pharmaceuticals Ind. Ltd., TGO – Global Operations
- 1999 – 2007: Director of Engineering, Teva Pharmaceuticals Ind. Ltd., Israel Operations
Prof. Rolf Jung
Professor and lecturer at University of applied sciences Albstadt-Sigmaringen
Prof. Jung works in the pharmaceutical industry for over 40 years and during that time participated in projects for companies such as Sanofi Aventis, Novartis, Pfizer GmbH, Teva Pharma, Bayer.
- 1994 – 2011 – University of applied sciences Albstadt-Sigmaringen, Professor
- 1980 – 1995 – Pharma Consult GmbH (Senior project manager, Partner, General manager)
- 1974 – 1980 – Sanofi Aventis, Cologne (formerly Nattermann & Cie. GmbH) – Assistant to the board of directors, Project manager new pharmaceutical production facility, Vice president industrial engineering
- 1970 – 1973 – Metallgesellschaft AG, Frankfurt, Battelle Institute, Frankfurt (Investment planning, Market research studies)
Quality Director, FAVEA Group
Zdenek Pavelek graduated from the Masarik University in Brno (Czech Republic), faculty of natural Sciences.
Since 2014 Zdenek Pavelek is responsible for the Quality System in the engineering company FAVEA Group as Quality Director.
- 2009 – 2014 — QM Director at TEVA Czech Industries.
- 1994 – 2009 – Head of Consultancy department at G.M.Project.
- 1992 – 1994 – Head of QA Department at Galena (Czech Republic)
Area Sales Director Eastern Europe, CIS and Africa, IWK Verpackungstechnik GmbH
Since 2012 Vitaliy Batyrev working in the company IWK Verpackungstechnik GmbH.
- Kiev state University.
- The University of Passau. The faculty of law.
- The Munich Academy of Economics, professional qualification degree of MBA.
In addition to his native Russian language, Vitaliy is fluent in English, German and Polish.
Директор по продажам, Dividella
Senior Manager Process Design, Robert Bosch Packaging Technology GmbH
Dieter Rapp is responsible for design, layout and specification of complete pharmaceutical production lines including pure media systems, clean room design and HVAC systems. Further duty is the consulting of clients due to GMP design issues.
Qualifications: Dieter Rapp is holding a bachelor degree of mechanical engineering of the Dual University of Heidenheim, Germany.
He has 26 years of experience in GMP regulated pharmaceutical industry in Europe.
In his function as senior manager process design in Integrated Solutions Pharma department (Bosch Packaging Technology) he gained experience in GMP engineering of process systems, layout of facilities and consulting of European pharmaceutical companies in the field of Aseptic filling, Liquid and solid dosage, Plant design.
Group Leader Technical Sales (Pharma), HEUFT
Stephan Bachmeier has a degree in mechanical engineering and has been working for HEUFT SYSTEMTECHNIK GmbH in Germany for almost 10 years.
He started as a product manager for full automatic leak detection systems and is in his current position in charge of the global project team responsible for sales, projecting and qualification of HEUFT inspection equipment for pharmaceutical customers.
Area Sales Manager, Dara Pharmaceutical Packaging
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.
Manager, Global Integrated Projects, Fedegari Group
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.
Sales Area Manager, IMA SpA-IMA LIFE Div.
Marcello is currently Sales Area Manager of IMA LIFE Italy. He joined the IMA Group in 2012 from Marchesini Group where he was employed as Sales Manager and Key Account Manager.
Before joining Marchesini Group in the 2008 he was first employed in a GRAHAM Packaging Branch in Italy as Sales Director for Middle East and East Europe from 2001.
Department Leader Barrier Technology, Harro Höfliger
Bernhard Brugger is Department Leader Barrier Technology at Harro Höfliger Verpackungsmaschinen GmbH since 2008.
Before joining HH he spent over 25 years in different positions in companies specialized in cleanroom and barrier technology. His experience covers equipment and process technology for aseptic processing, containment and cleanroom technology.
He is responsible for the equipment needed to fulfill the aseptic and containment requirements of the HH machinery. If processes have aseptic requirements, need special temperature and humidity conditions, are running under inert atmosphere or require containment he and his team provide the suitable solutions.
Maria Concetta Santangelo
Project Management, TECNinox Srl
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.
Technical Director, Pharma Union
Graduated from Moscow Institute of Chemical Engineering.
Alexander Rosol has the extensive experience in the sales of the equipment for the pharmaceutical industry.
He joined OOO “Pharma Union” in 2008.
He is responsible for the sales of “Bausch + Ströbel” pharmaceutical equipment in Russian Federation and CIS countries.
Prior to “Pharma Union” he worked in “Mashpharm Technology Limited” for 10 years. He was responsible for the sales of the equipment for the pharmaceutical industry produced by “Bausch + Ströbel”, “Stilmas”, “OLSA”, “ICOS”, “PCE”, “EISAI”, “Zirbus”.
Dr. Thomas Zimmer
Vice President of European Operations, ISPE
Since Nov. 2013
ISPE VP European Operations
- Former chair of the industrial advisory board of the Beuth Institute at the University of Applied Sciences Berlin Germany (12 years)
- Former chair of the EFPIA Anticounterfeiting working group (9 Years)
- Former member WHO Taskforce International Medical Products Anticounterfeiting
- Taskforce IMPACT Regulatory Group, Author of amended GDPs (3 Years)
- Former chair of the Board of Directors of the Pharmaceutical Security Institute (PSI) (2 years)
- Former member in various working groups for manufacturing and quality of EFPIA (10 years)
- Former rapporteur for Quality in the Pharma Manufacturing Forum (Global Heads of Operations Big Pharma, Top 15) (7 years)
- Former member Steering Committee DEUTSCHE GMP KONFERENZ PTS/University of Applied Sciences Albstadt Sigmaringen (19 Years)
- Former chair of ISPE International Leadership Forum (1 year)
During this time, Thomas Zimmer wrote numerous publications about relevant topics for quality, safety, technical operations excellence, supply chain management, anticounterfeting, drug shortages prevention, computerized systems governance.
Managing Director, OOO Testo Rus, the Russian subsidiary of Testo SE & Co. KGaA
After graduation from the Russian Mendeleev University of Chemical Technologies with a degree of environmental engineer, Ivan Sokolov worked for a Russian HVAC company in various executive positions. Back in 2005 he started working for a German group Testo AG, and became head of its Russian subsidiary. For now Testo Rus is one of the leading suppliers of measuring instruments and systems for various sectors including food and pharmaceutical industries. The company actively cooperates with leaders of pharmaceutical market, both producers and distributors of pharmaceutical products.
In recent years the company has brought to the market various solutions to control cold chain, carried out a great number of projects to equip laboratories, storage facilities, and logistics centers with climate monitoring systems, and also reached leading positions on the market of temperature mapping and validation. Ivan Sokolov and other experts of the company are frequent speakers on the topics of implementation of GxP at many industry-specific events.
ISPE representative, Deputy Director Customised Systems, Senior Project Manager ZETA Biopharma GmbH
DI (FH) Matthias Goriupp is Senior Project Manager and Deputy Director of the ZETA Business Line “Customised Systems”. He has more than 15 years of experience in the field of the pharmaceutical industry. In 2002, Matthias Goriupp joined the ZETA family as a Project Technician. During his career as a Project Manager, Matthias Goriupp finished his studies of “Industrial Engineering” at the University of Applied Sciences in Graz and became Deputy Director of the Business Line “Customised Systems” in 2013. Matthias Goriupp managed several big projects in Germany, Ireland, Switzerland, Singapore and China with a focus on upstream processes, media/buffer preparation as well as buffer storage, inactivation skids and clean media supply and distribution. During his professional career, Matthias Goriupp has been working in many different projects in the field of super-skid design.
Regional Manager CEE/Italy/Turkey/Russia ELLAB A/S
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.
Engineer-technologist, ZETA Biopharma GmbH
Igor Smirnov has worked as an engineer-technologist in ZETA Biopharma.
He has over 5 years of experience in the field of qualification/validation, performed conceptual design, basic and detailed engineering for the biotechnological manufacturers. In 2014, Igor became part of a larger family of ZETA. Igor participated in several large projects for customers from Russia, Austria and South Korea, mainly in the field of processes “upstream”, systems preparation/storage of nutrients and buffer solutions, systems of preparation and distribution of clean media (PW, WFI, CIP, SIP). In addition, Igor has participated in FAT, SAT and commissioning installation of Freeze & Thaw ZETA‘s systems.
Business Development Manager, Klimaoprema d.d.
Graduated from the University of Kazakhstan, the direction of an interpreter and business communication.
2013 – started working as an assistant to the Head of Sales in the Russian Federation and CIS countries in Klimaoprema d.d., Croatia.
After that she was appointed to the position of sales manager in Russia and CIS countries.
Since the end of 2016 she has been working as a business development manager in Russia and CIS countries.
Regional Manager, Russia, CIS & Baltics, KeyPlants AB
20 years’ experience of Business Development, Client Development, Sales & Marketing within leading Design and Engineering companies at the Pharmaceutical and Biopharmaceutical market.
Technical Director, LLC “KPO-Electro” / Drager
Vladimir is a certified specialist in Drager equipment for more than 20 years. He has extensive practical experience of solving various technical problems in manufacturing plants. Years of cooperation with project institutes on issues related to the systems of gas analysis.
Education: Moscow State Open University (MSOU)
Work experience: Anton has 15 years of experience in commercial and pharmaceutical industries. Since 2011 he heads the company SolidPharma.
Marketing Development Director (Russia, Kazakhstan, Belarus, Armenia), Condair AG
Ms. Bernstein is a strategic marketing and business development expert. She has 25+ years of experience in industrial, political, cultural and social institutions in Germany and Switzerland. Since 2012 she heads a Russian representative office of Condair AG (Switzerland), the world leader in manufacturing of air humidifying equipment. Ms. Bernstein specializes in managing large-scale industrial and infrastructural projects, which involve governmental authorities’ and business owners’ efforts.
EU Engineering Director, Patheon (now part of Thermo Fisher Scientific), Italy
Alberto Penati received a High Technical School degree in thermotechnology engineering at the Feltrinelli Industry Institute in Milan, in 1990.
From 1991 up to 1995 he worked at the FOSTER WHEELER Italy, Machine Dept., HVAC section, as a HVAC and utilities engineer for pharmaceutical and industrial plants. After a brief experience of one year (1995) at Woods (Italy), he was employed at Steril S.p.A up to 1998, as HVAC Engineer for pharmaceutical and biotech plants. After an experience in Eleca S.p.A. from 1998 up to 2000 as Project Engineer of mechanical plants, erection and construction, from 2000-2004 he worked at Jacobs Italy as HVAC and utilities Specialist for pharmaceutical, chemical, biotech and other appliances plants. From 2004 up to 2010 Alberto worked at CSV Life Science, for Project Management and Validation activities in the Pharma sector. He is currently at Patheon, Italy (now part of Thermo Fisher Scientific) as EU Engineering Director.
Project Manager, GEA Germany
Eduard Oster, Mechanical Engineer, with 7 years experience in project management thereof 5 years for international projects in the pharmaceutical industry. Currently project manager for freeze drying equipment at GEA Lyophil GmbH in Germany. Eduard is managing international projects worldwide and already had several projects in Russia, Kazakhstan and Belarus.
Head of Department for organization of cooperation pharmaceutical inspectorates of EAEU, FBI «SID & GP»
- Saint-Petersburg State Chemical-Pharmaceutical Academy;
- Advanced training in GMP/GDP-inspections; GMP-inspector.
- Certified GMP/GDP facilitator of WHO Global Learning Opportunities.
- ISPE member since 2017
Embarked on his career at the production site of active pharmaceutical ingredients. From 2008 to 2013 Vladimir worked at the State Research Institute of High Pure Biopharmaceuticals (Federal Bio-Medical AgencySt. Petersburg) as a Validation Engineer. In 2013-2014 he participated in the launch phase of “Novo Nordisk” – an insulin production site in the city of Kaluga. There he was in charge of manufacturing of aseptic and sterile production. In 2014 Vladimir joined the newly created Inspections Department at the State Institute of Drugs and Good Practices, where he progressed from the position of a leading expert/auditor all the way to Deputy Head of the Department. In 2017, he was appointed as Deputy Head of the institute’s training center.
Project manager, Bürkert Fluid Control Systems
- November 1992: Hecht Reinmedientechnik Roman Druckgastechnik GmbH
– Sales Manager for High Purity Gas Equipment for Dräger Tescom AG
- July 1993: Hecht Reinmedientechnik GmbH/ Technology Centre Bodnegg
– Sales and Installation for High Purity Gassystems
- 1994 -1997: Project Manager for High Purity Projects
- 1999 – 2006: Project management medical gas supply systems in Russia
- 1997 – 2004: Set up of a Pharma Piping Group
- 2004 – February 2006: Sales and marketing for Pharma systems and piping
- 2006 – 2009: Gemü GmbH + Co. KG – Key Account Manager Novartis worldwide
- 2009 – 2011: Head of Sterile Departement
- 2011 – 2014: Technical Support and Project management
- 2014 – 2015: Wilhelm Guth GmbH * Co. KG – Head of Sterile Departement
- 2014 – 2017: Neumo GmbH + Co. KG – Technical consultant sterile applications International sales heat exchanger and vessels
- since April 2017 Christian Bürkert GmbH + Co.KG – Project manager
Senior Scientific Consultant, FAVEA Group
Education: Master degree 1981 at University Jan Evangelista Purkyne, Brno, Faculty of Science, subject: biology. RNDr. Degree at University J. E. Purkyne Brno– institute of microbiology, 1982. Postgraduate degree 1998 at IPVZ Praha (pharmaceutical technological processes and toxicology).
Length of experience: 44 years.
FAVEA Group 2017
– Senior Consultant (consultation, GMP auditing, toxicology reports)
G. M. PROJECT, since 2007 on positions:
– Head of Technology Development Department 2007 – 2009
– Head of Consulting Department 2009 – 2014
– Senior Scientific Consultant 2014 – 2016
Galena a.s., (hereafter IVAX Pharmaceuticals, now TEVA Czech Industries s.r.o.) on positions:
– Research Technologist of R&D Biotechnological Department 1983 – 1991 (responsible for science/technological support and realization of biotechnological plant (submersion fermentation) incl. laboratory
– Head of API Production Department 1991 – 1995 (GMP principles implementing and receiving of GMP certificate for 15 APIs)
– Pharmaceutical Production Director 1995 – 2007 (GMP principles implementing and receiving of
– GMP certificate for product of Liquid (sterile, non-sterile), OSD and SGC forms
Validation Specialist of the Division of Good Engineering Practice, FBI «SID & GP»
Director, NICOMAC EUROPE SRL
Starting as a sales man he took over the family business, turning it from a commercial company into an industrial company with three plants, two in Italy and one in India. Nicomac is also a majority shareholder of Euronovis SRL which deals with third parties in the nutraceutical field using equipment and cleanrooms produced by Nicomac. He has full responsibility for Business Development and Project Management, coordinating all companies activities transversely and taking care of the development of projects in the first person.
SINGLE ADMINISTRATOR OF TOMIRIS SRL
TOMIRIS is the company that owns the independent publishing house Silviarech, whose main objective is the dissemination of non-profit books. Passion and love for the quality written word is the push that allows us to sustain this effort publishing five books, four written by himself.
Steering Committee Member of the ISPE SPP CoP
Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG BioTech Group in Europe and Steering Committee Member of the ISPE SPP CoP. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
Manager International Sales, robatherm
09/16 – 08/17
International Sales engineer at robatherm
09/17 – now
Manager International Sales at robatherm
10/10 – 09/14
University of applied Sciences Ansbach Energy and environmental systems technology
10/14 – 06/16
University of applied Sciences Augsburg Environmental and process engineering
Armen L. Paravyan
President, «InterPharmTechnology Group»
Entrepreneur, inventor, investor. Higher medical education. Professional interests are technologies of active longevity, pharmaceuticals, bioengineering, robotics, business process automation, information systems. 1991 – founded the first wholesale pharmaceutical company CJSC MENCH. 1994 – founded the company “Interpharmtechnology Ltd” – the supply of pilot equipment for testing the production technology of medicines. 1998 – formed a group of companies under the common brand name “Interpharmtechnology Group” with the introduction of industrial process equipment to the market and the production of consumables from rolled polymeric materials (companies of the group in Russian Federation Pharmintec Ltd and Plastintec Ltd). Patents in the field of clinical medicine, medical devices.