Hard to Handle: An EU Clinical Trials Seminar

Many products are hard to handle but not impossible, with Clinical trials becoming more complex as more challenging products are introduced. With applications for biotech patents increasing 25% year on year the market growth has continued to outstrip that of small molecules and there are few signs that this trend will slow down.

Ineffective management of clinical supplies can account for 40 percent or more of a company’s entire R&D budget, therefore, an effective supply chain management strategy is paramount.

Join PCI Pharma Services and our Partners World Courier as we examine some of these challenges and offer proactive solutions to your supply chain planning to ensure a safe and uninterrupted supply of life-changing therapies to patients worldwide.

Thursday 22nd September 2022 – Renaissance Paris Arc de Triomphe – 4-6PM

Hard to Handle: An EU Clinical Trials Seminar

Please view the schedule below

3.00pm – 4.00pm: Registration

4.00pm – 4.15pm: Welcome and Introduction

LISA SPENCE, DIRECTOR, CLINICAL SUPPLY CHAIN – EMEA / APAC
There are innumerable variable elements within any clinical trial and risks that may impact a study’s chances of success. From protocol interpretation and review, early operational planning and forecasting to assessing different scenarios and budget management, determining these factors and their potential impact on the program as early as possible can prove invaluable to the overall suitability and performance of the supply chain. In this presentation Lisa will provide an insight into some of the tools used to streamline your study start up and ensure the successful execution of your study.

REBECA BRUZZICHESSI, QP
Companies conducting clinical trials in the EU are about to see the largest shake up of legislation
for years with the introduction of the EU Clinical Trials regulation (CTR). Whilst these changes will
streamline and improve the legislative and regulatory framework for clinical trials across Europe, they
also pose significant challenges for sponsors. In this presentation QP Arthur Stevenson will present
the new regulations and what it means for your drug development programs.

JEROME DETREILLE, SENIOR DIRECTOR, NEW BUSINESS DEVELOPMENT
Many products are hard to handle but not impossible. With the complexities involved in the safe
handling of many of today’s more complex drug candidates, coupled with increasing regulatory
requirements, it is imperative to understand the challenges to enable the successful development of
such products. In this presentation Jerome will discuss the key considerations in the development,
manufacturing and packaging of these more challenging products.

DAVID SPILLETT, WORLD COURIER
Moving any medication through the supply chain can be challenging, but cell and gene therapies
(CGT) are particularly complex. That’s because in addition to making sure the right drug reaches
the right patient at the right time – these therapies have a very tight temperature profile. In this
presentation, David Spillett, an industry veteran, will discuss the challenges in today’s changing
environment, and how to keep your life-saving and life-changing shipments safe, secure with product
integrity intact, ensuring patient safety.
6.15pm – 9pm Close out and Networking Event

Be sure to stay for our social networking event!
We hope to see you there!

Register your interest in joining this seminar below: