Join PCI for a complimentary educational lunch event

The face of clinical trials is constantly changing with more challenges for drug developers than ever. Two core themes define this, new and evolving technologies, and more difficult disease targets.

Compounds for these targets tend to be riskier to develop and more expensive to produce. With this in mind the “too hard to handle” seminar will address the complexities of moving these compounds through the supply chain safely and efficiently whilst reducing uncertainty and cost.

The programme includes:

How Hard is Hard?

Examining the complexities of taking these ‘hard to handle’ molecules through the manufacturing process including; the changing pharmaceutical landscape and the molecules considered “potent”, The Occupational Exposure Limit (OEL) assessment of potency, the latest internationally recognised guidelines the handling of potent molecules and the state of the art equipment that ensures adherence to best practice through contained processing.

Turning Challenge Into Opportunity

As todays early phase drug compounds and chemical structures become reliant upon stringent storage, atmospherically and temperature controlled conditions, PCI looks at some of today’s complex packaging challenges including the challenges in monitoring or maintaining low humidity, Nitrogen flushing, the practical challenges of packaging in refrigerated environments as well as the complex logistics of packaging Controlled Substances.

Clinical Trial QP Challenges; Practical examples from the real world

Join PCI for an overview of the challenges facing the QP as they look to assure a robust and efficient supply chain. Furthermore the QP acts as the regulatory gate keeper to ensure that product certified is in full compliance with EU directives and regulations. During this presentation, we will examine specific scenarios where PCI QPs have has to overcome challenging scenarios to ensure drug product availability to clinical trials has not been compromised.

It’s a Small World

At a time when supply chain integrity is receiving unprecedented interest from regulatory authorities World Courier considers the implications of a truly global supply chain, accessing the emerging markets, handling dangerous goods and ensuring GXP compliance through risk assessment and effective temperature control.

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