Regulatory Updates

Hear the latest update of regulatory landscape around the globe.

Recent CNPPA Guidance and Technical Documents Related to Pharmaceutical Packaging
Yonghua Gao

Yonghua Gao, CNNPA

  • Yonghua Gao (Deputy Secretary-General at China National Packaging)

    Yonghua Gao

    Deputy Secretary-General at China National Packaging
Applying the recent CDER – CBER COVID-19 Container Closure System Guidance: Glass Vials and Stoppers
Donald Klein

Donald Klein, DNK Consulting

  • Donald Klein (CMC Consultant at DLK Consulting Services)

    Donald Klein

    CMC Consultant at DLK Consulting Services
Introduction of PDA Standards & Recent PDA Activities
Bettine Boltres

Bettine Boltres, West Pharmaceutical Services

  • Bettine Boltres (Principal Scientific Affairs at West Pharmaceutical Services)

    Bettine Boltres

    Principal Scientific Affairs at West Pharmaceutical Services
Break
Automation in Secondary Packaging

Automation continues to bring benefits to all areas of the pharmaceutical industry. In this session, you will hear how full traceability, digitalization and new approaches to inspection & packaging can support adherence to regulatory requirements, timely delivery of product and ultimately more patient safety.

Roger Asselta, Genesis Packaging Technologies (Invited)
Philippe Lauwers, Terumo (Invited)

Medical Device Tracking and UDI Serialization
Georg Schick

Georg Schick, Uhlmann

  • Georg Schick (Strategic Product Manager at Uhlmann Packaging Systems)

    Georg Schick

    Strategic Product Manager at Uhlmann Packaging Systems
New Requirements of the Inspection & Packaging Process for Small Batch Sized Medicines
Felix RiehnManuel Huber

Felix Riehn and Manuel Huber, Koerber Pharma

  • Felix Riehn (Head of Product Management at Körber Pharma)

    Felix Riehn

    Head of Product Management at Körber Pharma
  • Manuel Huber (Product Manager at Körber Pharma)

    Manuel Huber

    Product Manager at Körber Pharma
Container Closure at Deep Cold Storage

One of the topics brought to the forefront by the COVID-19 pandemic is deep cold storage and transport, a topic that will remain critical moving forward especially in the area of cell and gene therapy. This session addresses the challenges primary packaging systems have to maintain good container closure integrity at these deep cold storage temperatures.

Container Closure Systems for Cell & Gene Therapy
Roman MathaesFederico Sabini

Roman Mathaes and Federico Sabini, LONZA

  • Roman Mathaes (Head of Pharmaceutical Services at Lonza DPS)

    Roman Mathaes

    Head of Pharmaceutical Services at Lonza DPS
  • Federico Sabini (Lead Scientist, Primary Packaging at Lonza)

    Federico Sabini

    Lead Scientist, Primary Packaging at Lonza
Cold Storage Container Closure Integrity of Vial Primary Packaging Systems
Yusuf Oni

Yusuf Oni, BMS

  • Yusuf Oni (Principal Engineer at Bristol-Myers Squibb Company)

    Yusuf Oni

    Principal Engineer at Bristol-Myers Squibb Company
Selection of a Primary Container Closure System Capable of Maintaining Closure Integrity During Deep Cold Storage
Jennifer RiterSinue Gomez

Jennifer Riter, West
Sinue Gomez, Corning

  • Jennifer Riter (Senior Director, Analytical Services and Integrated Solutions of West Pharmaceutical Services)

    Jennifer Riter

    Senior Director, Analytical Services and Integrated Solutions of West Pharmaceutical Services
  • Sinue Gomez (Product Development Manager at Corning Pharmaceutical Technologies)

    Sinue Gomez

    Product Development Manager at Corning Pharmaceutical Technologies
Break
Sustainability

Learn about the recent efforts of the industry to advance sustainable manufacturing and waste management.

Sustainable Packaging in Merck Healthcare Supply Chain
Corinne Ondo Ngwa

Corinne Ondo, Merck KGaA - Healthcare

  • Corinne Ondo Ngwa (Head of Sourcing Healthcare Innovation at Merck)

    Corinne Ondo Ngwa

    Head of Sourcing Healthcare Innovation at Merck
State of Biopharma Recycling – What Has Been Done and What Can be Done in Different Global Regions and What is on the Horizon
Jacqueline Hollands

Jacqueline Hollands, MilliporeSigma – Merck KGaA -Life Science (Invited)

  • Jacqueline Hollands (Global Manager, Product Recycling & Innovation at MilliporeSigma)

    Jacqueline Hollands

    Global Manager, Product Recycling & Innovation at MilliporeSigma
Container Closure Integrity Testing Training
Oliver Stauffer
  • Oliver Stauffer (CEO of PTI - Packaging Technologies & Inspection)

    Oliver Stauffer

    CEO of PTI - Packaging Technologies & Inspection

    Oliver Stauffer received his Bachelors of Science degree from the University of Michigan and completed his MBA at Georgetown University. He began his career in analytical and R & D laboratories, with a focus on sensory technologies, physio-chemical measurement and test method development specific to package testing. Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of high-risk pharmaceutical packaging. In 2006, he joined the sales team as applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, followed by COO through 2015, focusing on global quality solutions for package inspection that provide the highest level of measurement accuracy and reliability. During his time with PTI he has developed several technology platforms, measurement methodologies, and technology patents. In 2016, he was appointed as CEO.

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