Pre-Conference Workshop Day

8:30 AM - 12:30 PM Workshop A - Devising a Strategy That Addresses the Needs of Patient, the Asset and the Company

Tom Watson, Pre-approval Access Consultant, TW Consulting Group
In this tailored and highly interactive workshop, you will engage with the workshop leader and other attendees on the current global climate for Early Access Programmes, and the resulting pressure points, before deep diving into three key programme challenge areas.

You will be invited to share your specific and unique challenges with the workshop leader ahead of the conference, ensuring that the workshop content is tailored specifically to help you resolve your current programme challenges and devise effective solutions to drive your programme forward.

What You will Gain from this Workshop:
  • Personalized advice and solutions based on your specific needs and challenges
  • Improve your understanding of the current global Early Access Climate, and the inherent pressure points within these programmes
  • Effective strategies for clearly identifying the goals for the Patient, the Asset and the Company in order to design a more robust programme
  • Learn to align programme objectives across all key programme stakeholders
  • Effectively incorporate all of the factors that need to be included as part of a flexible management strategy

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Tom Watson

Pre-approval Access Consultant
TW Consulting Group

1:30 PM - 5:30 PM Workshop B: Ensure a Targeted and Successful Access Programme by Creating a Comprehensive Regulatory and Logistical Roadmap

Carlos Camozzi, Group Chief Medical Officer, Simbec Orion David Schwicker, Principal, ORPHA Strategy
In this collaborative and interactive workshop, you will have the opportunity to map out the regulatory and reimbursement challenges you are facing across the global market, with the workshop leader then targeting your specific challenges and providing you with a tailored map of the key strategies required to successfully address the challenges associated with EAPs in focus geo-regions.

Having learned to manage your regulatory pathway across a variety of prominent target markets, you will have the opportunity to engage with the workshop leader and other attendees to assess the challenges that surround supply-chain management and develop an effective product forecast strategy, mapping this onto your supply-chain roadmap, to ensure that you leave with a comprehensive understanding of the logistical space and ‘know how’ required to successfully deliver an Early Access programme.

What You will Gain from this Workshop:
  • Understand and effectively manage the specific regulatory requirements for your programme across a number of the most prominent regions for EAP roll-outs.
  • Improve your business strategy and decision making skills to ensure that your company is regulatory ready
  • Create a roadmap of strategies to address the supply and forecasting challenges of running EAPs so that you can deliver a sustainable programme from start to finish

Carlos Camozzi

Group Chief Medical Officer
Simbec Orion
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David Schwicker

Principal
ORPHA Strategy