Pre-Conference Workshop Day | Tuesday, March 19

7:00 am Check In & Morning Coffee

Workshop A – One-Stop Shop to Successfully Streamline the Process of Setting Up an EAP

8:00 am Apprehending the Lessons Learnt from Established EAPs to Develop Robust Strategies That Align with Specific Product Portfolio


Looking to set up an EAP but unsure on how to start? This session will outline the initial steps that drug developers have employed in their programs to give you the roadmap to success and help you start off on the right foot.

What will you take away from this session?

• Guidance on how to develop your Expanded Access policy

• How to receive requests in a more digestible format and transparently manage requests across the organisation

• Framework for how to communicate and reach physicians and patient advocates

7:00 am Check In & Morning Coffee

Workshop B – For Experts with Established Programs: Navigating the Regulatory Landscape & Mitigating Operational Issues

8:00 am A Deep Dive into How to Optimize the Operationalization of Your Current EAP

  • Annie Drelles Director & Head, Office of Medical Access, Daiichi Sankyo, Inc.


Once a program has been established, it is often difficult to maintain effective communication and understand all the varying regional requirements. Join this interactive discussion to mitigate these challenges by hearing previous success stories.

Hear from and join experts in discussing:

• Global updates to the current laws and regulations

• Enhancing the collaboration between healthcare providers and regulators to ensure a mutual understanding of the requirements and operational considerations

• What data to the regulators need to see?

• Maximizing the management of reporting

10:00 am Morning Break

10:30 am Constructing an Ethical & Reliable EAP System to Manage Requests

  • Rachel Harrison Pre-Approval Access Program Lead, Global Medical Affairs, argenx
  • Christopher Robertson Professor of Health Law, Policy, & Management, Boston University
  • Donna Cowan Associate Director, Expanded Access Programs & Registry, Stealth Biotherapeutics


You’ve now developed your EAP policy and a method for physicians to reach you. Next, you’ll need suitable internal tools to help you track all the cases and a team to review them.

How will this session help?

• Timelines to set up system including the process flow for management of requests when using a vendor

• Understand the necessary workflows required

• Determine whether to leverage a dedicated internal team or seek external help to manage the cases

10:30 am Better Understanding the Approach Towards Post-Trial Access

  • Benjamin Rotz Associate Vice President, Global Medical Policy Strategy & Operations, Eli Lilly & Co.


As these programs are expensive to set up and operate, there is a risk to your company if the drug isn’t commercialized. An exit strategy must be clearly defined.

Attend this discussion for answers on the following:

• What are the options when ending a program in a country where the drugs won’t be commercialized?

• How do you communicate upfront to investigators your plan when the study ends?

• When a clinical study is done, to what extent is a company obligated to keep giving the drug?

• How do you maintain ethical responsibility to patients that’d benefitted from the program?

3:00 pm Lunch Break

1:30 pm Navigating Local & Global Regulations Whilst Strengthening Cross-Functional Relationships


Whether in-house or with the help of an external vendor, you’ll need to understand regulators’ requirements along with best practices for labelling, shipping, and reporting.

What will you learn in this session?

  • An in-depth understanding of country-level challenges and how to mitigate them
  • How to identify the countries to consider
  • A beginner’s guide to optimizing cross-functional involvement. E.g., supply chain, market access 

1:30 pm Exploring Methods to Effectively Involve Patients in the Set Up of EAP & How to Best Support Them


Patients are the heart of these programs. Delve into the essential strategies needed to ensure patients receive timely access to investigational therapies while receiving necessary support.

What will be your key takeaways?

• Operationalize working with patients and patient advocates

• The ethical considerations needed to guide eligibility criteria and patient selection

• Enhancing program efficiency by leveraging technology and data-driven insights

3:30 pm Afternoon Break

4:00 pm Streamlining Expanded Access Workflows Through Digitization


  • End-to-end enrolment support: from request capture to closure.
  • Connecting all stakeholders through a compliant and secure platform.
  • Capture Real World Data, maximizing uptake and quality together with physicians.
  • Customizable, real-time reports to leverage insights and analytics.

6:00 pm End of Pre-Conference Workshop Day