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Pharma

Drug/Device Combination Products Design & Development Summit

  • 2nd – 3rd March 2017
  • Germany flag Germany Berlin
  • Hotel Riu Plaza Berlin Martin-Luther-Straße 1, 10777

Combination products are still relatively new delivery systems for health care professionals and patients. New techniques and methods are crucial for precision administration with minimal chance of incurring harm. Technical requirements are ramping up through new regulations and legalisms.

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About

Combination products are still relatively new delivery systems for health care professionals and patients. New techniques and methods are crucial for precision administration with minimal chance of incurring harm. Technical requirements are ramping up through new regulations and legalisms.

It is an honour and privilege to invite you to discuss the key aspects of design control and latest practices in combination products development.

Who Should Attend

Chief Executives, Vice Presidents, Directors, Department Heads, Leaders, Managers specialising in:

  • Combination Products
  • Autoinjectors
  • Design Controls
  • Human Factors
  • Device Development
  • Device Manufacturing
  • Quality Assurance/Control
  • Compliance
  • Risk Management
  • CMC
  • Pre-filled Syringes
  • Parenteral Products
  • Device Design
  • Usability Engineering
  • Device Engineering
  • Drug Delivery
  • Product Quality
  • Regulatory Affairs
  • Research and Development
  • Packaging

Key Practical Learning Points

  • Aligning regulations and processes
  • Key aspects of design control implementation
  • Risk assessment for faster product realisation
  • Insights into V&V methodology
  • Best practices in testing and evaluations
  • Human factor analysis
  • Technical challenges and correct specifications

Jakob Lange, CH

Senior Director, Delivery Systems

Ypsomed AG

Jakob Lange is an engineer and materials scientist by training with a master’s degree in chemical engineering from the Royal Institute of Technology in Stockholm, Sweden, and a PhD in polymer science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers, and is a regular contributor to technical and scientific conferences. Jakob started his professional career as a research scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, Switzerland. He then worked in R&D management with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006. With Ypsomed he has held different positions within marketing and sales as well as in R&D project management. Currently he is a senior director of delivery systems, overseeing two teams of product managers, one managing Ypsomed’s autoinjector platforms and the other focussing on customer relationships for device development projects and marketed device products.

DR. STEPHEN A. BARAT

Head of Pre-Clinical & Early Clinical Development

Head of Pre-Clinical & Early Clinical Development

Dr. Stephen A. Barat is the head of pre-clinical development and early clinical development for Scynexis, a biotechnology company focusing on development and commercialization of novel anti-infective treatments for life-threatening infections. He is a member of the Scynexis senior management team and has 20 years of experience in global drug devel­opment and registration from large multi-national pharmaceutical com­panies. Dr. Barat is a member of the PQRI working group for leachables and extractables for parenteral drug products and a member of the USP expert panel for biocompatibility testing. He has been an invited speaker and avid participant in various international venues on pharmaceutical development and a contributor to many continuing education courses, particularly in the area of safety assessment of impurities.

DANIEL SHOUKIER

Regulatory Consultant & Lead Auditor

Bellingswood Group

Daniel Shoukier is a worldwide-recognized expert for drug combination products. He is the Managing Director of the Bellingswood Group, a con­sulting company for global market access and registration of medical devices and drug combination products. He is also a lead auditor and medical expert for a Swiss notified body. In the past, Daniel was Vice President at Novo Nordisk, heading up Regulatory Affairs for medical devices. Before this he was the Global Director for regulatory affairs at Biosensors. He also worked as a lead auditor at TÜV Rheinland.

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

Mike Wallenstein has over 25 years of experience in QA, R&D, and manufactur­ing within the medical device & pharmaceutical industry with positions as head of quality systems, global head of auditing, and compliance. His is currently director of QA & global head of device & combination product expert network at Novartis International, based in Basel, Switzerland.

Bijan Elahi , NE

Global Product Risk Management Consultant, Educator

Medtronic

Bijan Elahi has worked in risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He is currently employed as a technical fellow at Medtronic, where he serves as the corporate expert on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequent speaker at professional conferences and is also a contributor to ISO 14971, the international standard on the application risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.

FLORIAN WILDENHAHN

Section Head Human Factors Engineering

F. Hoffmann-La Roche

Florian received his Product Design diploma in 2003 from the Univer­sity of Kassel, where he focused on medical device design. Florian has 13 years of industry experience, developing devices for parenteral drug delivery as well as polymer primary packaging systems for various cus­tomers in the pharmaceutical industry. He joined Roche’s device develop­ment group in 2009, where he was responsible for usability engineering and Design Validation of Roche’s Pegasys ProClick autoinjector. In 2011 he took over the role of the device team leader for the Actemra SC pre-filled syringe, launching the product in 2013. Since 2017 he is leading the Human Factors Engineering group within Roche Pharma.

UDO STAUDER

Global Device Project Leader

Sanofi-Aventis

Mr Stauder is an accomplished development leader in the field of phar­maceuticals. With 13 years working in Sanofi he as aquired compitent skills and efficency in project development. He has oversaw several com­bination products projects providing leadership for fast track solutions and compliance as well as planning and establishing of production plants for Invitro Diagnostica. Today Mr Stauder leads development, submission and worldwide launches for new drug delivery devices and will be sharing with us, his techniques and vast experience in a multitude of different applications for project execution.

DIEGO VARGAS

Senior Scientist

Sandoz

Diego has more than 15 years of experience in Biotechnology Industry. Started his career at Merck & Co Vaccine Technology Department, in the drug product formulation department as formulation process engineer, process validation, as well as container closure & sterile filtration subject matter expert. Subsequently, joined Amgen Inc. in 2010 in drug prod­uct development & commercialization as packaging/primary container expert, where major contributions were in the field of testing method development for incoming primary containers, platform development and combination products verification method validation. In 2015, joined Sandoz GmbH as combination product expert. Among the different roles include the establishment of a primary container and device functional testing laboratory, more recently leading the design verification testing for auto-injectors and needle guards. Diego has a bachelor and master degrees in Chemical Engineering from City University of New York.

CARSTEN WORSØE

Principal Scientist

Novo Nordisk A/S

Carsten Worsøe is a principal scientist in an analytical development de­partment at Novo Nordisk. In his 19 years at Novo Nordisk, his main responsibility has been to develop analytical methods for Extractables and Leachables (E&L) test procedures of new drug products and devices under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical chemistry together to perform risk assessments and strategies for E&L testing in development and supply projects within parenteral delivery (prefilled cartridges, prefilled syringes and pump infusion systems etc.)

RUSSELL COLE

Staff Design Engineer

BD

Russell Cole is a mechanical design engineer at BD, specializing in in­novating drug delivery devices for high volume manufacturing. Recent accomplishments include designing and launching the first reuse preven­tion syringe able to prevent reuse of the most common vaccine dose size (300M+/year), designing intradermal insertion and infusion devices to deliver through the lymphatic system and designing a smallest-in-class catheter insertion mechanism for a disposable combination infusion device. His recent focus has been on adopting new rapid prototyping and metrology technologies and pioneering new design methods and techniques in order to speed the typical time from concept generation to clinical launch. Prior to designing medical devices he designed consumer products and haptic robotic arms and software that simulate touch in virtual reality.

DR. IR. LISE VANDERKELEN

Department Head Pharma Services

Toxikon Europe N.V.

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience En­gineering at the University of Leuven (Belgium) in 2012. She started at Toxikon Europe in 2013 as study director at the Extractables & Leach­ables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. Today, she is Department Head Pharma Services at Toxikon Europe.

OLIVER VALET

Managing Director

rap.ID Particle Systems

Dr. Oliver K. Valet is one of the co-founders of rap.ID Particle Systems GmbH a company that develops manufactures and sells unique particle identification systems. Within the last 15 years their patented technology fuses particle isolation, imaging analysis and spectroscopic technology together to powerful investigation tools. Streamlining particle contamina­tion identification and particle characterization. Within rap.ID Dr. Valet is responsible for the product development and worldwide marketing and sales. From the FDA inspected industrial forensics laboratory work per­formed at both rap.ID sites in Berlin, Germany and Princeton, New Jersey Dr. Valet has more than a decade experience in the field of industrial and environmental chemical analysis on particles. As an active member of the Respiratory Drug Delivery, RDD, the Royal Chemical Society, Parenteral Drug Association, PDA and American Association of Pharmaceutical Sci­ence, AAPS and the Apothekerverband, APV he has published his work continuously and presented on various conferences.

ANDREW FEILDEN

Chemistry Operations Director

Smithers Rapra  Smithers Pira

Dr Andrew Feilden is the chemistry operations director at Smithers Rapra and Smithers Pira. He leads the chemistry groups at both the Shawbury and Leatherhead facilities in the UK. The Leatherhead site specialises in food contact testing whilst the Shawbury site carries out extractable and leachable testing, GPC analysis and food contact testing. He has been with Smithers for over 5 years, prior to that he worked for AstraZeneca, specialising in Extractables and Leachables. He has a degree and D Phil from the university of York, is a fellow of the Royal Society of Chemistry and is a Scientific advisor to IPAC-RS.

Jakob Lange, CH

Senior Director, Delivery Systems

Ypsomed AG

DR. STEPHEN A. BARAT

Head of Pre-Clinical & Early Clinical Development

Head of Pre-Clinical & Early Clinical Development

DANIEL SHOUKIER

Regulatory Consultant & Lead Auditor

Bellingswood Group

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

Bijan Elahi , NE

Global Product Risk Management Consultant, Educator

Medtronic

FLORIAN WILDENHAHN

Section Head Human Factors Engineering

F. Hoffmann-La Roche

UDO STAUDER

Global Device Project Leader

Sanofi-Aventis

DIEGO VARGAS

Senior Scientist

Sandoz

CARSTEN WORSØE

Principal Scientist

Novo Nordisk A/S

RUSSELL COLE

Staff Design Engineer

BD

DR. IR. LISE VANDERKELEN

Department Head Pharma Services

Toxikon Europe N.V.

OLIVER VALET

Managing Director

rap.ID Particle Systems

ANDREW FEILDEN

Chemistry Operations Director

Smithers Rapra  Smithers Pira

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