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Thursday, April 08, 2021 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central) 60 min

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Pharmaceutical packaging capabilities are often constrained by the capital costs in rolling out new equipment and meeting flexible packaging production schedules. This is especially problematic when scaling up packaging activities from clinical to commercial as forecasts become more sophisticated and flexibility, collaboration and communication is necessary.

The journey from clinical operations to commercialisation possess a slew of challenges such as package design, documentation preparedness, capacity issues, general growth complications, internal culture, management maintenance, and standardizing a complicated operation for the mass market. Avoiding these pitfalls, in order to achieve efficiency and alleviate delays, requires subject matter expertise, a lean and continuous improvement mindset and the ability to form strategic partnerships.

This presentation will examine these scale-up challenges and suggest ways to best overcome them.

What You Will Learn

  • The internal & external forces impacting the scaling of clinical and commercial drug and how to alleviate these issues
  • The different aspects to consider at the clinical stage that will save time and money at commercial scale-up
  • What key technologies to consider to help complement clinical trials on the path towards commercialisation.

Who Should Attend?

  • Small/virtual, medium & large pharma
  • Trial sponsors, particularly those at late stage II-III of trial
  • Clinical and commercial teams

Managers, directors, leads or heads of:

  • Packaging development / design
  • Supply chain / Supply chain planning / Supply chain management
  • Program management
  • External supply
  • Operations / Manufacturing operations / External operations
  • Outsourcing / Purchasing / Procurement
  • Vendor management
  • CMC
  • Clinical project managers
  • Clinical Outsourcing
  • Clinical trial design

Our Speakers

John Hogan, Projects/Commercial Manager, Sharp

John started out his career in the medical device industry managing product lifecycle and new product introductions. From design and development lifecycles through feasibility, validation and eventually full production and ‘End of Life’ with companies such as Depuy, J&J and Boston Scientific.

Nick Seibert, Account Executive, Sharp

Nick has worked within the pharmaceutical packaging industry for 10 years, working at Sharp for the entirety and holding different roles within the company. He started off in the quality department as an inspector, as well as responsible for investigating and authoring non-conformity reports.

Sharp has partnered with @BerkshireSM to provide clients with a seamless, end-to-end #pharmaceutical manufacturing, packaging & distribution solution.

Learn more about how our combined expertise can benefit your project: https://lnkd.in/eW4QmJm

Are you registered for tomorrow's webinar?

Don’t miss your opportunity to hear from our experts as they discuss both the internal & external forces impacting the scaling of #clinical & #commercial drugs and how to avoid these pitfalls.

Register here: https://lnkd.in/eHFmUh8

Sharp has appointed Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services.

https://www.sharpservices.com/resources/news/sharp-appoints-eu-qualified-person/

#QualifiedPerson #MarketRelease #QualityManagement