12-13 November 2019, Lisbon/Portugal
Elisabeth Vachette is managing Product Management for Bags/Mixing/Tanks within the Single Use Fluid Management Technologies Department at Sartorius based in Aubagne, France.
Since joining Sartorius Stedim Biotech in 2000, she has been responsible for quality, production, engineering and now product management providing a broad view of the functionalities of single-use solutions development, marketing, qualification and manufacturing. She is an active member of scientific committees for PDA conferences and is member of the BPSA board of directors.
Guido Kremer-van der Kamp has more than 20 years of experience in the BioPharmaceutical industry with single-use, multi-use, facility, and process design. He has held various positions with global responsibilities in process development, operations, consulting and technology management. He is currently Associate Director of Technology Management at Merck developing and implementing Global Programs. Guido graduated in Biotechnology at the University of Applied Science in Mannheim with tenures at the National University of Singapore and a student fellowship at the Institute of Molecular and Cell Biology (IMCB) in Singapore.
Burkhard Wichert is the founder of Pharma Operations Solutions, providing solutions across Operations from scale up, manufacturing, quality to contract development and manufacturing business.
During the 30 years in the Pharmaceutical Industry Burkhard held multiple global positions optimizing product design and quality as well. Burkhard was leading the global contract manufacturing organization for Baxter, and was the European head of operations overseeing 12 plants in 11 countries, as well.
Burkhard is Pharmacist, with a Ph.D. from the University of Muenster (Germany), post- doctoral studies at the University of Florida in Gainesville and an MBA from Chilterns University, UK.
Loraine Bout is the Regional Intelligence Manager, EMEA & APAC at Sensitech. In this role, Loraine is responsible for developing, implementing and delivering the EMEA & APAC intelligence strategy.
Prior to her current role, Loraine worked in several roles in the security field within the Dutch government.
She served as a Policy Advisor for the Minister of the Interior and Kingdom Relations. In this role, Loraine was responsible for the quality alignment of law enforcement in the Dutch Kingdom.
Loraine gained experience in international policy making as a Policy Officer at the World Health Organization.
Loraine holds a Master’s degree in Criminal law and is based near Amsterdam, The Netherlands.
Mehul Chhaya is the Global Head of Quality for Supply Chain for Novartis Technical Operations. He has over 26 years of diverse industry experience including 5 years in Novartis. In the current role Mehul is responsible for end-to-end supply chain within technical operations and related quality and compliance areas i.e. Swissmedic QPs and licenses, warehousing, transport, logistics, product life cycle management, QA contracts and related internal and external stakeholders management. In his previous assignments within Novartis, Mehul has led roles with increasing responsibilities in Asia, USA and Europe.
Prior to Novartis, Mehul has lead very diverse roles within Quality and Compliance functions with various Pharmaceuticals, Medical Devices and Food Industries in corporate and manufacturing site leadership roles. During his work tenure, Mehul had been instrumental in implementation successful quality strategies during major business transformations, quality culture changes and quality remediations.
Mehul holds Bachelor degree in Microbiology (1993), and Masters in Business Administration (1997).
Kim holds an M.Sc. in Biochemistry from University of Copenhagen and has worked in the biopharmaceutical industry for more than 35 years. He was a protein chemistry principal scientist, project director, chief operating officer and chief executive officer, and spent 20 years with Novo Nordisk and 5 years with CMC Biologics.
Kim is the co- founder of L&K Biosciences, SMC Biotech, Hejnaes Consult, help4biotech and invest4biotech. He serves as an adjunct professor in Biotechnology at University of Aalborg, Denmark.
Since 1998, Kim Hejnaes has focused on outsourcing aspects of Chemistry, Manufacturing and Control (CMC) operations with involvement in a substantial number of international biotech projects over the years.
Markus holds an Executive MBA from Business School Lausanne, Switzerland and a Federal Diploma for Logistics Management from GS1, Switzerland.
He has over 20 years of international experience as senior executive and consultant within various industries like Mining, Chemical, Pharmaceutical, Minerals and Manufacturing.
During the past 25 years, he has implemented demanding & complex projects in the field of logistics & supply chain management, automation and as well as in ICT.
In 2018, he joined InterLog Management as Senior Consultant Professional and is also a member of the executive board.
Federico Lupp has held the position of Head of Business Development EMEA & ASAP since 2012. In 2008, he moved to Germany from USA, where he joined DHL Global Forwarding’s JV LifeConEx in 2005 as Sales Manager USA & Canada.
Federico has held various positions as Global Account Manager with the Life Sciences vertical Americas at Lufthansa Cargo in USA and his home country Argentina, where he started his career at Lufthansa Cargo back in 1987.
Federico Lupp attended Veterinary Medicine School at the Universidad de Buenos Aires, and earned a master’s degree. Born in Argentina, he resides permanently in Frankfurt, Germany.
Gert-Jan joined AbbVie in January 2014 as QA Program Manager within the global Supply Chain Compliance team focusing on Traceability and Serialization, Supply Chain Security, Supply Chain Visibility, and Medical Device Life-Cycle Management.
Gert-Jan is Program Lead for implementing the EU Safety Features (EU FMD program) and is member of the Efpia Supply Chain and Coding & Serialization working groups. Located at AbbVie Logistics in Zwolle, The Netherlands.
As per March 2009 Gert-Jan became member of the PDA PCCIG EU Branch Steering Committee and has co-authored the article Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes (Pharmaceutical Outsourcing, Sept. 2017).
Prior to AbbVie, Gert-Jan joined Abbott in January 2007 supporting the global Cold Chain Management program. With 5 years of experience in food logistics and retail in previous roles, he became subject matter expert for Good Distribution Practices (GDP) compliance in the pharmaceutical industry.
Gert-Jan holds a bachelor’s degree in Business Economics and Logistics at the HES Amsterdam.