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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Pharma Logistics & Outsourced Operations 

12-13 November 2019, Lisbon/Portugal

  • Elisabeth Vachette

    Elisabeth Vachette

    Sartorius Stedim Biotech

    Elisabeth Vachette is a Product Manager for Single Use Fluid Management Technologies at Sartorius Stedim Biotech based in Aubagne, France. With a Biotechnology Engineer graduation of the ENSAIA of Nancy and 15 years of experience, Mrs. Vachette supports the biopharmaceutical industry on a world-wide basis, in particular in process design, validation, training and implementation of single-use fluid management technologies.

    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, qualification and manufacturing.

  • Nina Heinz

    Nina Heinz

    DHL Global Forwarding

    As Global head of Network & Quality at Temperature Management Solutions at DHL Global Forwarding/LifeConEx, Nina Heinz works with her team to cover a wide array of quality matters in regulatory compliance, audits, training, partner management, customer complaints and continuous improvement.

    Nina played a key role in the implementation of the global DHL Thermonet network of GDP-compliant life sciences stations, including the internal DHL Thermonet GDP guidelines, training programs and internal audit certification to ensure full regulatory compliance.

    As an IRCA Certified Quality Auditor, she is also very active in performing audits at airports worldwide in coordination with the respective handling and airline partners to assess their capabilities in facilitating temperature-sensitive life sciences shipments.

    Nina is a member of the IATA Time & Temperature Task Force and has been working closely on the developments of IATA Chapter 17 of the Perishable Cargo Regulations. In addition, she is a certified IATA instructor and played an important role in establishing the IATA pharmaceutical cargo handling three-day course.

    Nina is a also member of the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) European branch within the Parenteral Drug Association (PDA).

  • Sarah Hockey

    Sarah Hockey

    Novartis
    Sarah Hockey, currently Global Head for External Supply Operations, Quality Systems and Compliance at Novartis. Sarah has been working in the pharmaceutical industry in Quality and Production roles for approximately 25 years in QC, Quality Assurance and Compliance, Solid dose manufacturing and packaging activities and external supplier management.
  • Guido Kremer-van der Kamp

    Guido Kremer-van der Kamp

    Merck KGaA

    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.

  • Siegfried Schmitt

    Siegfried Schmitt, PhD

    PAREXEL

    Siegfried provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance.

    Siegfried holds the position of Vice President Technical at PAREXEL Consulting. His areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products, for all types of formulations.

    Siegfried is a seasoned and experienced auditor, providing support to clients pre and post inspections or audits. Siegfried has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB.

    As an active member of various industry associations, Siegfried is a frequent presenter and committee member of international events. He is also an accomplished author and editor as well as member or chairman of several editorial boards. Dr. Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.

  • Burkhard Wichert

    Burkhard Wichert, PhD

    pos Wichert

    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

    Loraine Bout

    Sensitech

    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

    Mehul Chhaya

    Novartis

    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).

  • Fabian De Paoli

    Fabian De Paoli

    GSK Vaccines

    Fabian De Paoli holds a Master Degree in Applied Biology from the Catholic University of Louvain-La-Neuve, a degree in Management Mastery from EPM, as well as a degree in electro-mechanic engineering from the ECAM, Brussels.

    Since 1984, Fabian has held several positions at GSK Vaccines with responsibilities in the areas of Production, Quality Control, Engineering and Manufacturing Centre of Excellence. He spent the last 15 years in Packaging, Warehousing and Cold Chain activities. In his current position, as Director Vaccine Distribution and Cold Chain, he is in charge of the development of standards, qualify solutions and improvement of processes in the area of cold chain, storage/warehousing and distribution activities.

    Fabian is a member of the PDA Pharmaceutical Cold Chain Interest Group (PCCIG) – European Branch. He is the co-author of a peer-reviewed article on PDA TR 53 Guidance for Industry “Stability testing to support distribution of new products. He represented the Industry on the Packaging working Group (WHO).

  • Andrea Gruber

    Andrea Gruber

    International Air Transport Association

    Mrs. Gruber is Head, Special Cargo at the International Air Transport Association (IATA) and is responsible for delivering international standards and business processes for the air cargo supply chain.

    Mrs. Gruber is leading IATA’s Cargo governing bodies, comprised of airlines and air cargo supply chain stakeholders that provide the regulations for the air transportation of Live Animals, Perishables and Healthcare Products. She is secretary to the IATA Live Animals and Perishables Board and the Time and Temperature Working Group.

    Mrs. Gruber developed and implemented for the industry three Center of Excellence (CEIV) quality audit programs certifying the handling and transport of pharmaceuticals, live animals and perishable products based on IATA, national and international requirements and standards.

    Prior to working with IATA Mrs. Gruber worked at the International Road Transport Union (IRU) as head of a division implementing, at the Customs and business level, tools to assist the application of risk management. Mrs. Gruber studied in Geneva at the University and at the Graduate Institute of International Studies (I.U.H.E.I.) and holds a Master of Sciences in International Relations.

     

  • Kim Hejnaes

    Kim Hejnaes, MSc

    Hejnaes Consult

    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.

  • Victor Huart

    Victor Huart, PhD

    METROPACK
    Victor Huart is a Research and Development Manager at METROPACK in Reims, France. He holds a Packaging Engineering degree of the ESIReims (ESIEC) and a Ph.D on safety and industrial risk of transport. Victor is specialized in the mechanical stress studies and the packaging mechanical behavior during transport. Integrated in 2013 at METROPACK, a laboratory of test and transport simulation on packaging, he investigates the mechanical behavior of packaging and the fatigue phenomena. At METROPACK, his main aim is to develop methods of transport analysis, establish audits of the customers’ supply-chains and their packaging.
  • Wouter Huizinga

    Wouter Huizinga

    IDT Biologika
    Wouter Huizinga studied organic chemistry and Biochemistry at the University of Nijmegen in the Netherlands. He held research positions at the Universities of Alabama and Nijmegen, before starting his commercial career with Lonza where he held several positions in the contract manufacturing space for small molecule APIs and biotechnology derived products in the Netherlands, USA and in Switzerland. In 2003, he extended his expertise towards finished dosage forms manufacturing and held key business development and sales positions with global organizations such as Patheon, Dr. Reddy’s Laboraties and Baxter BioPharma Solutions. Since 6 years he is responsible for the European Contract Manufacturing business for Vaccines and Parenterals within IDT, and Key Account Manager for several large Pharma Accounts.
  • Ian King

    Ian King

    Takeda
    Ian has been the Head of External Supply Quality Europe since joining Takeda in April 2017, providing Quality oversight to the Takeda European network of CMOs.
    Prior to joining Takeda Ian held various roles over his 29 year career, starting with SmithKline Beecham in 1990 where he held positions in Quality Control, Quality Assurance, and Production. He later worked for Wyeth/Pfizer in Regional Quality roles with responsibilities for manufacturing sites, Contract Manufacturing Organisations, and distribution. Moving to Germany in 2012, Ian spent five years working at Sandoz International as Head Global External Supply Operations QA, and later as Head Regional Commercial Operations Quality Europe.
  • Markus Lanz

    Markus Lanz, MBA

    InterLog Management

    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

    Federico Lupp

    DHL Global Forwarding

    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.

    He has been a speaker at many international customer events in Europe, Asia, Latin America, and is an official IATA trainer for Chapter 17 Time & Temperature Sensitive Products
  • Damien Moncond'huy

    Damien Moncond’huy

    Dev'Pack
    Damien Moncond’huy is a Packaging Engineer at Dev’Pack in Reims, France. He holds a Packaging Engineering degree from ESIReims (ESIEC). Since 2018, Damien works with Dev’Pack, a Packaging Development agency specialized in secondary and tertiary packaging systems development (grouping and transport packaging system). He helps Dev’Pack’s customers to enhance, optimize, and/or create packaging solutions which will effectively protect their products. 
  • Joaquin Santos

    Joaquin Santos Benito

    Janssen Supply Group
    Joaquin is a chemical engineer by Salamanca University and holds MBA´s by Autónoma de Madrid and IESE Business School. He has broad experience as a chemical process engineer, in Technical Operations, Supply Chain Management, Plant Director and as European Business Development Director with the joint venture J&J – MSD. Later on within Janssen Joaquin has lead SC departments at the facilities in France (VdR)  and Belgium (Beerse). Finally he has lead all External Operations of Janssen Pharmaceutica for EMEA & LATAM Region during the last 8 years. Joaquin is now starting at Pulsar Consulting to support Business Development and Strategic insight in the Pharma arena.  Additionally, he has been teaching Chemical Engineering at the UNED University in Madrid and is supporting a MBA on Advanced Management (covering all Outsourcing area) at the University of Alcalá de Henares in Madrid. 
  • Gert-Jan van Diest

    Gert-Jan Van Diest

    AbbVie

    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.