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Post-Conference Workshops

MORNING WORKSHOP A

09:30 AM Implementing New Supply Chain Concepts: Examining Direct To Patient and Demand-Driven Supplies Projects

Bengt-Simon Feth, Director, Project Management Europe, Marken Sascha Sonnenberg, Vice President Global CTD Sales & Operations, Marken
This workshop will focus on how the clinical supply chain can be effectively and proactively managed through the use of innovative technologies, partnering with industry, and planning industry concepts. Learn how you can ensure the success of a direct to patient trial and how you can react efficiently to new demand-driven supply projects that arise throughout the pharmaceutical industry.

How Attendees Will Benefit:
  • Learn Best Practices and Gain Industry Knowledge
  • Review Case Studies for Global DTP Project and Global Demand Driven Supplies
  • Identify Internal And External Challenges Encountered During Implementation
  • Lessons Learned from Both Case Studies


Bengt-Simon Feth

Director, Project Management Europe
Marken

Sascha Sonnenberg

Vice President Global CTD Sales & Operations
Marken

AFTERNOON WORKSHOP B

11:45 AM Configurable vs. Individual IVRS (IRT, IXRS) Systems

Nimer Yusef, CEO, Trial-Brian
This workshop will focus on the differences between configurable vs. individual IVRS systems from the users perspective, taking into account the possible risks, benefits and how we currently experience these systems. We will analyse the benefits and pitfalls, what we can expect in the future and how we see the current development trends.

In this session you will understand:
  • How to best appreciate what the user needs from the IVRS systems and successfully implement these
  • Assessing the baseline for a decision configurable vs. individual vs mixed IVRS within your organisation
  • How to improve user experience on IVRS systems and effectively roll these out company wide
  • Future trends and abilities of IVRS systems, and use this to influence the direction of your implementation


Nimer Yusef

CEO
Trial-Brian

1:30 PM Workshop lunch

AFTERNOON WORKSHOP C

2:30 PM Practical GDP – How to Apply The Rules and Regulations

This workshop will review the MHRA’s most commonly reported GDP deficiencies, sharing practical experiences and best practice to ensure that Quality Management Systems address their issues in a
pragmatic, practical and robust way.

By attending this workshop, you will be understand the top five reported deficiencies that were covered at the MHRA’s conference and understand how you can avoid falling foul of the regulatory bodies across Europe. The deficiencies to be discussed during the workshop include:
  • Temperature control - understand the impact that environment/equipment has on your compliance
  • Personnel - Recognize the role and accountabilities of the Responsible Person and building a training needs matrix
  • Development of a Quality Management System - Building Quality Agreements and SOP’s to ensure correct handling practices within your organisation and that of your suppliers
  • Qualification checks - implementing and understanding how to analyse supply chain data
  • Understanding how Transport Performance Qualification can be used effectively