Speakers

Jacques Morenas
Deputy Director, The National Drug and Health Products Safety Agency, France

Vladmir Orlov
Deputy Head, Educational Center for Good Practices, State Institute of Drugs and Good Practices, Russia

Vee Revithi
Ex-Head of EOF/Greece GMDP Inspectorate and Ex-External Relations Europe, Greece

Bob Tribe
Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S, Australia

Chai Chong Meng
Head of Mammalian Manufacturing, Lonza Biologics

Vincent Loret
Site Director, GlaxoSmithKline

Jincai Li
Vice President, Biologics CMC Development, Tech Transfer, Scale-up & Clinical Manufacturing, WuXi Biologics

Raman Sirinivasan
Vice President Operations, Biocon

Qiwei Wu
Vice President and Process Development and Manufacturing, Livzon Mabpharm Inc.

Jeff Chen
Production Manager, Pharma Essentia Corporation

Marc O’Donoghue
Site Director API and Biologics Operations, AbbVie

Charlie Wakeham
Informatics CSV Consultant, Waters Australia Pty Ltd

Sook Peng Chua
ASEAN Regulatory & Quality Compliance Director, Johnson & Johnson, Singapore

Michelle Peake
Senior General Manager, PT Kalbio Global Medika, Indonesia

Georg Singewald
Head Quality, Asia Pacific, Solids & Special Technologies, Novartis, Singapore

Nigel Cheong
Head, Biomedical Sciences, Economic Development Board (EDB), Singapore

Hazem Eleskandarani
Global Director, Commissioning & Qualification, Johnson & Johnson, US

Frances Zipp
President and Chief Executive Officer, Lachmann Consultant Services, Inc., US

Frédéric Dietrich
Managing Director, Dietrich Engineering Consultants sa, Switzerland

Immaculada Gomez
Tech Transfer Lead, MS&T, Novartis, Singapore

Kamaljit Hunjan
Senior Vice President, Global Healthcare, CEVA Logistics, UK

Chang Teck Chung
Quality Director, FQMR, Shire, Singapore

James Weidner
Process Development Site Head, Executive Director, Amgen, Singapore

Rateb Al Jallad
Head of Supply Chain, Julphar Gulf Pharmaceutical Industries, UAE

Thomas Halfmann
Partner, Halfmann Goetsch Partner AG, Switzerland

Samuele Bissola
Technical Sales Manager, F.P.S. Food Pharama Systems srl, Italy

Ferry Soetikno
Chief Executive Officer, Dexa Group, Indonesia

Richard Chai
Technical Service Manager, STERIS Corporation, Singapore

Pierre Landais
Asia-Pacific Manager, Powder Systems Limited (PSL), Australia

Albert Dyrness
Chief Technology Officer, ADVENT Engineering, US

Christian Wolbeling
Senior Director Global Accounts, Werum IT Solutions, Germany

Sergio Mauri
Director of Marketing and Business Intelligence, Fedegari, Italy

Robert Lutskus
Global Product Delivery Manager – Informatics, Lonza Informatics, USA

Felix Mausolf
Regional Sales Manager, Groninger, Germany

Elad Mark
Technical Project Manager, Process, Novartis, Singapore

Mehul Patel
Global Director of Training, Charles River Endotoxin and Microbial Detection Singapore Pte Ltd., Singapore

Denise Tan
Principal Engineer, Process Development, Amgen, Singapore

David Staunton
Director of Site Services, Zenith Technologies, Ireland

Leonora Lim
Vice President, Life Sciences & Healthcare, Asia Pacific, DHL Customer Solutions & Innovations, Singapore

Wee Ming Chua
Managing Director, Halfmann Goetsch Partner AG, Singapore

Ee Lynn Kok
Director, Quality & Compliance, Johnson & Johnson, Singapore

Foo Suan East
Global Product Lead, Process Sciences and Technical Services, Baxalta, Singapore

Chong Hock Sia
Senior Consultant, Audit & Licensing, Director, Quality Assurance, Health Products Regulation Group,Health Sciences Authority (HAS), Singapore

George A. Kaliviotis
Senior Operations Start-Up Manager, Cell Culture & Central Services, AbbVie Operations Singapore Pte Ltd., Singapore

Thomas Terranova
Managing Director, Terra Asia Consulting Pte Ltd., Singapore

Li-Jun Sim
Technology Manager, Merck Pte Ltd., Singapore

Arnan Ben-David
former Director, Global Sterile Engineering, Teva Pharmaceutical Industries, Israel

Paolo Rampichini
Head Supply Chain, Pharma, Asia Pacific, Hoffmann-La Roche

Frédéric Dietrich
Managing Director, Dietrich Engineering Consultants

Robert Lutskus
Global Product Delivery Manager – Informatics, Lonza

Eleven years of professional experience.

Education: St. Petersburg State Chemical Chemical Pharmaceutical Academy; advanced training in GMP/GDP inspections/audit; certified GMP/GDP Inspector.

Professional background: Vladimir Orlov’s 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 FSI «SID & GP», where he progressed from the position of a leading expert/auditor all the way to Deputy Head of the Department. As of November 2016 his professional portfolio also includes supervision of the GMP laboratory at the Education Centre of the FSI «SID & GP».

Chong Meng currently heads the Manufacturing function of a large scale biotechnology facility with a headcount in excess of 160 and is responsible for all cell culture as well as purification operations in addition to production scheduling and deviations investigation. His scope has recently expanded to include master batch record documentation. He has also led his team through multiple successful FDA and EMA PAIs.

Prior to his current role, he was Senior Cell Culture Manager and was at one time managing the Production Support and Deviation Investigation teams concurrently.

Before moving into the biotechnology industry, he was acting Manufacturing Lead for an antibiotic production facility with a high throughput of 1900 tonnes per annum, followed by Manufacturing Lead for a multi-modular bulk steroidal API facility producing the company’s best selling franchise with an annual sales of GBP 6 billion.

Between 2006-2010, Chong Meng was a Senior R&D Process Engineer and led the commissioning effort for a GBP 38 million new late-phase pilot plant facility. Subsequently, he led the scale-ups & developments for 8 new chemical entities (NCEs) across 17 chemical transformational stages. He was also managing capital projects totalling GBP 2 million simultaneously.

In his career, Chong Meng has been frequently placed in roles to accelerate/ spearhead changes, identify best practices, streamline workflows. He is also known for his ability to make critical decisions.

Chong Meng received his MS in Chemical & Biomolecular Engineering from the University of Illinois at Urbana-Champaign with a perfect GPA.

Vincent Loret is the Site Director for the Tuas Vaccines manufacturing facility in Singapore. Vincent was appointed the GSK Tuas site lead in 2015.

He joined GSK in 2008 as the vaccines site lead in Hungary, where he was successful in improving performance and securing FDA approval for the site in 2010. He was then appointed to lead the Secondary operations in Belgium (formulation, filling, packaging activities) in 2012.

Vincent began his vaccines career with Sanofi Pasteur where he held various leadership roles in bulk production in France and South America.

He has a degree in Biotechnology from INSA, an engineering school in France and married with 3 children.

Dr. Wu Qiwei has more than 15 years of  US biotech industry experience in CMC development of monoclonal antibody and recombinant protein therapeutics.  In the past few years, his work focused on building the CHO-based monoclonal antibody technology platforms for biosimilar and biobetter in China.   Dr. Wu has a Ph.D. in Biochemistry from Simon Fraser University, Canada and completed his postdoctoral fellowship at Stanford University Medical School, USA.   He currently severs as VP of Process Development at Livzon MabPharma (China) Inc., Prior to this position, he was the VP of CMC, Technical Operation, Mabspace Biosciences Co.Ltd..

Sook-Peng Chua is the Snr Director, Business Quality for Johnson & Johnson based in Singapore. During her 27 years of career, Sook Peng has held technical and quality leadership roles with global healthcare, both pharmaceutical and medical device companies such as Baxter, GSK/GSK Biologicals. Sook Peng earned a Masters in Sciences from National University of Singapore after completing her research on Signal Transduction in Tumor Cells in Institute of Molecular and Cell Biology. She has extensive auditing, operational experience and has led several commissioning – validation projects in medical device, pharmaceutical greenfield startup manufacturing facilities.

Michelle Peake has been working in the field of biotechnology for over 20 years, for companies in Australia, England, Malaysia and Indonesia. She has worked in all areas from research, to process development, with her main experience in cGMP manufacturing for biopharmaceuticals. She has extensive experience in protein purification, tech transfer and fill/finish. In December 2003 Michelle was appointed as the Director of Manufacturing for Alpha Biologics, a biopharmaceutical CMO in Penang, Malaysia, where she was responsible for the design and construction of the Alpha cGMP facility and equipment and establishment of the company. Currently she is Senior General Manager at Kalbio Global Medika in Cikarang, Indonesia where she is responsible for multiple functions including QA, finance and business development.

Head Quality, Solids & Special Technologies, Novartis Pharmaceuticals, Asia-Pacific, Singapore.

Georg currently leads the Quality Organization of the Solids & Special Technologies Platform – Asia-Pacific, Novartis Technical Operations. Previous assignments include Quality- and Operational- Roles at Solids and Biologics Sites incl Quality Head and Site Director. Georg holds a Master’s Degree in Pharmacy and a PhD in Pharmacology from the University of Innsbruck, Austria. He is a trained Qualified Person and Executive MBA in Supply Chain Management (Swiss Federal Institute of Technology – ETH)

Nigel presently holds the post of Head, Biomedical Sciences.

He joined the Singapore Economic Development Board (EDB) in 2010, placed in charge of key accounts in both the research instrumentation and pharmaceuticals sectors. Following this, Nigel spent three years in New York as Centre Director, building and managing partnerships with companies in the northeast US, across a wide range of industries.

He returned to Singapore in 2016 to head up the Pharmaceuticals & Biotechnology industry sub-group, as part of the Biomedical Sciences division.

Hazem Eleskandarani holds a master degree in Mechanical Engineering from the University of Utah and is a licensed Professional Engineer.  Hazem has 30 years of diverse experience that includes manufacturing, plant engineering, process design, technology management, and project engineering.  He began his career in 1988 in the steel industry as an equipment engineer responsible for equipment PM and plant annual shutdown repairs.  In 1996, Hazem joined Fluor Daniel working on pharmaceutical projects, before moving to Jacobs Engineering process equipment group.  In 2000, Hazem joined Merck Process Engineering working on several global projects in Spain, Italy, Ireland, US and Singapore.  Hazem’s current role with Johnson &Johnson – since joining in 2014- is providing global leadership for C&Q planning and execution across J&J’s global portfolio of capital projects.  Hazem lives in Worcester, Pennsylvania.

As an expert in compliance enhancement, Fran develops program solutions to meet GXP compliance requirements. She has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval.  She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, Due Diligence evaluations (facilities; products; technologies) and more.

Frédéric Dietrich is the managing director of Dietrich Engineering Consultants. Dec are experts in supplying safe and contained powder handling solutions in the fine chemical and pharmaceutical industries.

Over the past 30 years Dec has gained extensive knowledge and experience concerning health, safety and containment in relation to powder processing.

Mr. Dietrich is a frequent speaker at conferences worldwide and his articles promoting safety aspects of powder handling have been published in scientific journals.

Mr. Dietrich holds a Master of Science (MSc) in Mechanical Engineering (Swiss Federal Institute of Technology Lausanne/EPFL).

Imma Gomez  has worked at Novartis for 24 years, the last 3 as Technical Transfer Lead and Life Cycle manager. She graduated in Pharmacy from Barcelona University (Spain) in 1991 and obtained her MBA in Pharmaceutical Industry from Barcelona University  in 1993.  Since 1991 she held several position in Ciba-Geigy in Quality Control laboratory continuing after the merge with Sandoz to become Novartis in 1997. Roles in QA and QC include Microbiology, Packaging Material,  Drug Product Laboratory Head, and Qualified Person for Spanish market.  Imma joined Novartis Singapore in 2012 as Analytical Science and Technology Facilitator and moved to Technical Transfer lead in 2014. She  likes to work in the area of interface between science and practice with pharmaceutical  development and commercial sites.

With 26 years logistics experience, Kamaljit has an in-depth knowledge of the supply chain industry and today leads a global sector team including operational excellence and transformation management at CEVA Logistics.  He is based from the company’s London Heathrow facility.

During his career, he has worked in a number of international roles in the healthcare, oil & gas, after market and automotive sectors and has been based in the USA, Singapore, Italy, UK and Belgium.

He holds a BSc in Production Systems, and a Masters in Business Engineering Management from Warwick University.  He is fluent in several languages.

Teck Chung is the Quality Director and FQMR, Shire, based in Singapore since 2016.

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest. We feel a strong sense of urgency to address the high unmet medical needs of these patient communities.

Prior to joining Shire, Teck Chung held the position of QA Operations Director (Asia), Abbott Nutrition (Asia) and Site QA Director, Abbott Manufacturing Singapore during 2011-2016. Prior to that, he was the Quality Director at Pfizer/Wyeth Nutrition Singapore and Senior Technical Services Manager since the infant formula & adult nutrition greenfield startup in 2000 to 2011.

Between 1990 and 2000, he held various regional supply chain and API manufacturing operations positions with Exxon Chemicals/Shell joint venture startup, Schering-Plough Singapore API greenfield startup and GlaxoSmithKline Pharmaceuticals API.

He was a technical committee member of the WSQ Pharmaceuticals Quality (Food Science) Technical Committee, Workforce Development Agency (WDA), Singapore Ministry of Manpower. He is also appointed as WSG SkillsFuture Career Advisor (Manufacturing sector), Workforce Singapore (WSG), Singapore Ministry of Manpower.

Teck Chung holds a MBA from University of Tasmania (Australia), a Graduate Diploma in Business Administration from Singapore Institute of Management and a Bachelor Honours degree in Chemical Engineering from University College Dublin, Ireland.

James Weidner has 23 years of large and small molecule experience with Amgen, Hoffmann-La Roche, and Biogen Idec.  He has led Process Development, Manufacturing, Engineering and Automation groups in commercial facilities in the USA, Puerto Rico and Singapore.   Mr. Weidner currently serves as the Process Development Site Head at Amgen, Singapore.

Thomas Halfmann is founder and managing partner of HGP. HGP is a healthcare industry consulting company with offices in Switzerland, Germany, Poland, Singapore and Indonesia. Before founding HGP, Thomas was Global Head Biopharmaceutical Operations IT and Head of the Global MES Program, both at Novartis. Thomas is an expert in paperless manufacturing, business process analysis and modelling, project management, quality management, and computer system validation with more than 25 years experience in the healthcare industry. Since January 2018 Thomas is Operations Director of the OPEN-SCS Working Group and ISPE member for more than 20 years.

Mr. Dyrness co-founded ADVENT Engineering Services, Inc., an engineering and compliance solution provider to the life science industry.  Mr. Dyrness is a Principal and Chief Technical Officer.  Mr. Dryness is a member of the American Society of Mechanical Engineers Bioprocess Equipment (ASME BPE) Standards Committee, and is serving as the Chairperson for the ASME BPE System Design subcommittee. Mr. Dyrness is also an Industrial Advisory Board Member of the University of the Pacific’s Bioengineering program.  Mr. Dyrness received an M.S. in Mechanical Engineering from Massachusetts Institute of Technology and holds professional engineering licenses in the state of California for Chemical Engineering and Mechanical Engineering.

Christian Woelbeling is Senior Director Global Accounts at Werum IT Solutions based in Lueneburg, Germany, part of the Körber Medipak Systems Group. Werum is the market leader in Manufacturing Execution Systems / MES Solutions for the Life Science industries, working for 17 out of the Global Top 30 Pharma Companies with more than 800 installations. He helds a Master Degree in Mechanical Engineering. Since more than 25 years working in Life Sciences Manufacturing IT Christian has had great experience in all GMP related processes. He has broad activities inside the ISPE as Chairman of the Special Interest Group “Pharma 4.0”,  ISPE “GAMP MES Special Interest Group” Co-Chair, ISPE GAMP Member at large of the European Steering Committee, “Knowledge Network Council” Co-Chair, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member.

Sergio Mauri holds a Chemical Engineering degree. He has been involved in cleanroom technologies since 1980 and is currently, in charge of Marketing & Business Intelligence at Fedegari Group, after many years dealing with the design and the 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 2018-2020 term, and ISPE and PDA member since 2001. Promoter and responsible of the training course on “General introduction on Clean Room Technology, isolation concepts and critical parameters definition”. He is Trainer on pharmaceutical HVAC design for students of chemical and pharmaceutical technology at Italian Universities. Author of several papers on clean technologies and experienced giving training lectures to AIFA GMP Italian inspectors.

Rob Lutskus is a subject matter expert on laboratory informatics within quality control for the bio-pharmaceutical industry. Currently Global Product Delivery Manager of Informatics for Lonza Bioscience Solutions, Rob is responsible for the implementation, validation and technical sales support activities of Lonza’s Informatics software portfolio.

Rob has been a MODA SME for over 10 years, and working in QC laboratories and Laboratory Informatics for over 15 years. Originally a QC microbiologist, Rob has worked for Merck, Hoffman La Roche and Baxter before joining ImClone Systems in Branchburg, NJ.   In 2007, Rob led the original implementation of MODA EM as a custom solution then as the first customer of the commercial solution.  He joined Lonza in 2010.

Rob is also an active member in a variety of industry organizations, including the Parenteral Drug Association and ISPE.  He is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 1.

Elad Mark is a principal engineer with over 10 consecutive years’ of experience in the field of Biotechnology within diverse project stages including feasibility study, conceptual and detail design, commissioning, qualification and process validation. Elad has led a Global Engineering company through multiple projects, coordinating between projects different stages to deliver clients project requirements.

Mehul received his Bachelor of Science degree in cellular and molecular biology from the University of Michigan and his Master of Business Administration in finance from the University of Delaware. Mehul has over 18 years of extensive pharmaceutical and biotechnology industry experience in proteomic R&D, laboratory automation, product development and technical marketing. Currently he is the Global Director of Training for Charles River’s Microbial Solutions division and is responsible for developing and implementing global strategies in support of corporate initiatives.

Wee Ming CHUA is the Managing Director of HGP Asia Pte Ltd. A Biochemical Engineer by training, Ming has over 17 years of life sciences industry and consulting experience in emerging markets and international projects. He has worked in many projects in Pharmaceutical Manufacturing ranging from Biotech, API, Oral Solid Dosage to Aseptic Fill-Finish. Ming has expertise in quality systems, risk management, Validation and CSV. Notably, Ming has supported several business transformation and automation projects as CSV consultant and Project Quality Manager. Systems he has worked with include MES, LIMS, EQMS and other Information Management Systems.

Formal Education and Certifications

  • 2016 M.Sc, Industrial and Systems Engineering (Project Management), University of Singapore
  • 2010 B.Eng (Hon), Bioengineering, National University of Singapore

Employment History

  • 2017 Global Product Lead, Shire, Singapore
  • 2014 Lifecycle Management Project Coordinator, Baxalta, Singapore
  • 2012 Process Engineer, Baxter BioScience, Singapore
  • 2011 Manufacturing Engineer, Baxter BioScience, Singapore
  • 2010 Process Development Scientist, GlaxoSmithKline, USA

Sia Chong Hock holds a Bachelor’s degree in Pharmacy from the National University of Singapore, as well as a Master’s degree in Healthcare Management (with distinction) from the University of Wales.

Currently, he is the Director of Quality Assurance and Senior Consultant of Audit & Licensing at the Health Products Regulation Group of the Singapore Health Sciences Authority. He is also an Adjunct Associate Professor with the National University of Singapore. At the supranational level, he is the Chairman of the ASEAN Joint Sectoral Committee (JSC) tasked with the implementation of a pan-ASEAN Mutual Recognition Agreement (MRA) on GMP Inspection.

Periodically, Mr Sia contributes review articles to ISPE’s Pharmaceutical Engineering and other international scientific journals in the field of comparative pharmaceutical regulations for health products, including herbal medicines and health/dietary supplements, control of active pharmaceutical ingredients (APIs) and pharmaceutical excipients, supply chain integrity, and ASEAN harmonization on GMP Inspection.

In August 2016, he received the International Pharmaceutical Society of Pharmaceutical Engineering (ISPE) Singapore Affiliate Lifetime Achievement Award for his contributions to the field of Pharmaceutical Regulatory Practices and for his leadership in driving the harmonization of GMP Inspection standards across the 10 Member States of ASEAN. And more recently, in January 2017, an article which Mr Sia co-authored was named the winner of the ISPE Roger Sherwood Article of the Year 2016 Award.

Li-Jun Sim is currently Technology Manager, responsible for core technologies in Merck Life Science Process Solutions group. She has more than 6 years of hands-on experience in downstream biologics process optimization, scale-up and technology transfer projects. At her previous role in Manufacturing Sciences & Technology (MSAT) at Merck, she also led the Asian vaccine focal point team on thought leadership activities and innovative projects.

She graduated with a M.Sc. from the National University of Singapore (NUS) and has an Advanced Certificate in Training and Assessment (ACTA) from the Institute of Adult Learning (IAL), SkillsFuture Singapore agency.

Arnan Ben-David has 30 years of experience in engineering within the pharmaceutical and biopharmaceutical industries, working at Teva Pharmaceutical Industries and Omrix biopharmaceuticals (which become a company of JnJ Ethicon) as an engineering director and subject matter expert. Arnan specialized in sterile production including facilities design, aseptic processing equipment, clean utilities and sterile processes.

Paolo, an Italian citizen, has more than 20 years’ experience in Supply Chain Management in FMCG and Pharma Industries. In the first 9 years he worked for Unilever and Bic leading supply chain operations and projects. In 1999 he has joined Roche Pharmaceuticals as Supply chain and Procurement Director of the Italian affiliate and manufacturing plant. In 2008 he has moved to Roche headquarter in Basel, Switzerland leading Small Molecules Global Supply Chain and Global Supply Chain Transformation project. In 2014 he has relocated to Singapore to lead the Roche Pharma Supply Chain of Asia Pacific region in a highly developing environment. Outside work Paolo enjoys spending time with his family, travelling and the many other good things life can bring every day

Frédéric Dietrich is the managing director of Dietrich Engineering Consultants. Dec are experts in supplying safe and contained powder handling solutions in the fine chemical and pharmaceutical industries.

Over the past 30 years Dec has gained extensive knowledge and experience concerning health, safety and containment in relation to powder processing.

Mr. Dietrich is a frequent speaker at conferences worldwide and his articles promoting safety aspects of powder handling have been published in scientific journals.

Mr. Dietrich holds a Master of Science (MSc) in Mechanical Engineering (Swiss Federal Institute of Technology Lausanne/EPFL).

Rob Lutskus is a subject matter expert on laboratory informatics within quality control for the bio-pharmaceutical industry. Currently Global Product Delivery Manager of Informatics for Lonza Bioscience Solutions, Rob is responsible for the implementation, validation and technical sales support activities of Lonza’s Informatics software portfolio.

Rob has been a MODA SME for over 10 years, and working in QC laboratories and Laboratory Informatics for over 15 years. Originally a QC microbiologist, Rob has worked for Merck, Hoffman La Roche and Baxter before joining ImClone Systems in Branchburg, NJ.   In 2007, Rob led the original implementation of MODA EM as a custom solution then as the first customer of the commercial solution.  He joined Lonza in 2010.

Rob is also an active member in a variety of industry organizations, including the Parenteral Drug Association and ISPE.  He is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 1.