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2nd Pharma 4.0 Smart Manufacturing Summit

  • 9th – 10th September 2021
  • Zoom flag Zoom
  • ONLINE

How does Industry 4.0 change pharmaceutical manufacturing? Transitioning to Pharma 4.0 offers both new opportunities and challenges. 

This event provides an appropriate platform for industry professionals and technology leaders to discuss the best practices and experience of introducing, implementing and managing emerging technology capabilities.

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About the 2nd Pharma 4.0 Smart Manufacturing Summit

This Summit will focus on analytics and data integrity, automation, the workforce of the future, technical and operational transformation, and end-to-end integration.

Through case studies, interactive presentations, and discussions, attendees will discover how to start the digital transformation today!

Who Should Attend

SVPs, VPs, CEOs, Directors, Global Heads, Heads, Team Leaders, Specialists and Managers specializing in:

  • Medical Devices
  • Robotics & Control
  • CMC
  • Continuous Processing
  • Cell Culture Technology
  • Commercialization
  • Digital Strategy & Transformation
  • Data Integrity
  • Diagnostics
  • Quality Assurance/Control
  • Pharmaceutical Manufacturing
  • Product Quality
  • Process Monitoring
  • Pharmaceutical Manufacturing
  • Packaging
  • Compliance
  • Emerging Technologies
  • Licensing
  • Lifecycle Management
  • Regulatory Affairs & Licensing
  • Risk Management
  • Research & Development
  • Track & Trace
  • Scale Up & Tech Transfer
  • Sterilization
  • Supply Chain
  • Research & Development
  • Validation
  • Vaccines

Key Practical Learning Points

  • Implementation of the digital strategy
  • Automation and robotics
  • Workforce 4.0
  • Data connectivity, data management and impact on IT
  • Technical and operational transformation
  • GMP and continuous manufacturing
  • Cybersecurity
  • Environmental monitoring and energy management
  •  Logistics optimization

Dr. Frank Thielmann, CH

Operational Excellence Director - Region Europe

Takeda

Dr. Thielmann has a Ph.D. in Physical Chemistry/ Material Science from the University of Duesseldorf, Germany. Frank joined Novartis Pharmaceutical Development (Basel, Switzerland) in July 2007 as Formulation Lab Head. From 2009 until 2011 he managed the pharmaceutical development group in the UK. Upon his return to Switzerland he joined Novartis Technical Operations where he was managing the setup of a new solid dosage form manufacturing facility and the transfer of the corresponding portfolio before moving to the Biotechnology department as global Leader for PMO & Operational Excellence in November 2016, In this role, Frank had additional responsibility as Operational Excellence Head of the new Novartis manufacturing facility for Cell & Gene Therapeutics in Switzerland.

In November 2019, Dr. Thielmann moved to a new responsibility at Takeda Manufacturing & Supply as Operational Excellence Director, where he is responsible for the implementation of process improvement in the manufacturing of a wide portfolio ranging from small molecules to ATMPs with a special focus on digitalization & automation.

Dr. Thielmann is a member of the Steering Committee of the Material Science and Biotherapeutics Focus Group in the British Academy of Pharmaceutical Sciences. 

Dr. Pushkar Pendse, SG

Principal Consultant, Pharma 4.0 Lead

TÜV SÜD Digital Service

Dr. Pushkar Pendse is a Principal Consultant responsible for the Pharma 4.0 consulting at TÜV SÜD Digital Service in Singapore. He is a member of the global Pharma 4.0 working group at the International Society for Pharmaceutical Engineering (ISPE) and is part of the executive council of ISPE’s Singapore chapter. He has extensive experience in the life sciences sector, spanning from R&D to manufacturing operations and from small molecule drugs to biologics. He specializes in digital twins and advanced analytics and has led multiple digital innovation projects across the biopharma value chain. A chemical engineer by training, Pushkar holds a Ph.D. in complex systems modeling from the University of Maryland, College Park, USA.

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, phar­maceutical engineering, quality control at the University of Applied Sciences in Albstadt/Sigmaringen Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert Con­tainment Group of the ISPE DACH eight years ago. The Containment Group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Dr. Kirsten Frick, DE

Founder & CEO

PHARMAPLAN GMBH

Teresa Minero is the Founder and the CEO of LifeBee, a business consulting and digital company dedicated to life sciences since 2004.

She has more than 30 years of experience in managing international consulting and digital innovation projects for production, logistics, quality, regulatory, and R&D, and in managing startups and business divisions for international consulting groups. She has spent more than 25 years within life sciences.

In ISPE, she is currently part of the International Board of Directors, the European Leadership Team, and the Steering Committee Pharma 4.0™ Global Special Interest Group.

She has been a lecturer and chairman at many conferences and has authored several articles on digitalizing life sciences and Pharma 4.0™.

Lidia Korotaeva, DE

Architect

PHARMAPLAN GMBH

Lidia is an architect with about 7 years of professional experience. Lidia achieved two master’s degrees in architecture. She has worked on projects of different scales and stages. 

Lidia is used to working internationally. She developed projects around the world, working in Germany, China, Italy, and Russia. Her projects and studies embraced a wide range of topics including industrial buildings. 

Before joining Pharmaplan, Lidia worked on competitions and detailed architectural designs of commercial buildings in Germany.

CHRISTIAN WÖLBELING, DE

Executive Industry Advisor & Senior Strategic Account Manager Software

Körber Business Area Pharma

Christian Wölbeling is Executive Industry Advisor & Senior Strategic Account Manager Software at Körber Business Area Pharma, based in Lüneburg, Germany. With Werum PAS-X MES, Körber is the world’s leading supplier of Manufacturing Execution Systems (MES) and Manufacturing IT solutions for the pharma, biotech and cell & gene therapy industries. He helds a Master Degree in Mechanical Engineering. Since 30 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 Founder & 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, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member.

Named as “Pharma Industry Leader” by the ISPE Pharmaceutical Engineering Magazine 2020.

Dr. Dieter Peters, CH

President

Make Profit Growth Happen

Dr. Dieter Peters has 30-plus years of experience as a global operations executive in the pharmaceutical and chemical industry – turn arounds, profit improvement, reliability, and supply chain optimization. He advises senior leaders and their teams to develop strategies and their execution to transform their business by involving their people in an operational excellence culture aligned along the value chain to deliver increased cash flow, reduced risk exposure, and grow profit and business. Regions: North America, South America, Europe. Former positions: general manager and board member, EVP global product supply, site director, VP R&D organic chemicals, business analyst.

Teresa Minero, IT

CEO

LifeBee

Teresa Minero is the founder and CEO of LifeBee, a business consulting and digi­tal company dedicated to life sciences since 2004. She has more than 30 years of experience in managing international consulting and digital innovation projects for production, logistics, quality, regulatory and R&D and in managing startups and business divisions for international consulting groups. More than 25 years have been spent within life sciences. She is currently also the chair of the ISPE Italian affiliate, part of the ISPE European leadership team and part of the ISPE steering committee for Pharma 4.0 Global Special Interest Group. She has been a lecturer and chairman at many conferences and an author of many articles on digitalising life sciences and Pharma 4.0.

Arul Joseph, US

Senior Director, Pharmaceutical Development and Clinical Supply Chain

Avanir Pharmaceuticals

Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has more than 15 years of experience in chemistry, manufacturing, and controls (CMC) pharmaceutical development and has held roles of increasing responsibility at Gilead Sciences, Merck, and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA.  Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University's Stern School of Business in New York, NY

Sunil Patel, US

Director – Product Management

ValGenesis, Inc. 

Sunil has over 17 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors.  

Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.  

Prior to joining Valgenesis, Sunil has had variety of Validation roles as consultant and corporate employee with increased responsibilities within Pharmaceutical and Biologics industry including Catalent, Eisai, Pfizer, Teva and Novartis.  

Dr. Frank Thielmann, CH

Operational Excellence Director - Region Europe

Takeda

Dr. Pushkar Pendse, SG

Principal Consultant, Pharma 4.0 Lead

TÜV SÜD Digital Service

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Dr. Kirsten Frick, DE

Founder & CEO

PHARMAPLAN GMBH

Lidia Korotaeva, DE

Architect

PHARMAPLAN GMBH

CHRISTIAN WÖLBELING, DE

Executive Industry Advisor & Senior Strategic Account Manager Software

Körber Business Area Pharma

Dr. Dieter Peters, CH

President

Make Profit Growth Happen

Teresa Minero, IT

CEO

LifeBee

Arul Joseph, US

Senior Director, Pharmaceutical Development and Clinical Supply Chain

Avanir Pharmaceuticals

Sunil Patel, US

Director – Product Management

ValGenesis, Inc. 

BROCHURE 

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What our
participants
are saying

It's always exciting to share experiences with peers and colleagues! Great event about pharma and industry 4.0, we keep the discussion going on despite these difficult times.

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Massimo Pizzochero

Product Manager at SEA Vision

The Pharma 4.0 Smart Manufacturing Summit in Berlin was my first combined live and online event. Organization and prevention measures were outstanding at all times enabling a lively discussion in a comfortable and safe situation. It was rewarding to chat with experts live on pharma 4.0 status and progress as well as challenges in the supply chain which became obvious during the Pandemic. Thanks for this great event in today’s challenging times.

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Dieter Peters

President at Make Profit Growth Happen

It was a very high-level event, the organization was very good and the speakers too. I look forward to your next events and I hope you do more online because is easier to participate.

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