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Expanded Access and Named Patient Consultancy 2018-03-16T09:36:10+00:00

Expanded Access and Named Patient Consultancy

“Providing access to life-saving drugs for unmet clinical needs”

Expanded Access Programs (EAPs) and Named Patient Programs (NPP) are rapidly becoming an important part of any successful development plan. However, it can be hard to understand how these programs work and how best to implement one to meet your company’s needs.  

To successfully run an EAP or NPP, sponsors will need to understand the complexities involved in moving into new markets before marketing approval is received. We use our extensive experience to help you bridge the gap before commercialization rights are received. WEP Clinical can provide guidance on:

  • Developing a policy for allowing access to medicines in countries where they are not yet approved
  • Consistency across different territories
  • KOL engagement
  • Managing patient requests and expectations
  • Navigating the diverse, global regulatory landscape
  • Managing the logistics of distributing product around the world
  • Mitigating risks and any potential legal issues
  • How to navigate HIPAA regulations and handle confidential patient information