Successfully Managing The Risks And Challenges Of Orphan DrugsSource: World Courier Inc.
How to identify, assess and prioritise regulatory risks and challenges
Date: October 29, 2013
Time: 3PM London / 11AM New York
Section One: Orphan Drugs
With small population of patients, the orphan drugs face special challenges in delivering their life saving promises to patients who have great needs. There are difficulties making a timely and accurate treatment plan for patients with rare diseases. Not all healthcare providers who know how to diagnose many rare diseases. Not all providers are fully equipped to treat patients with rare diseases. Regulatory authorities face special challenges in reviewing and approving these therapies for their citizens' use. And it can be difficult to fund these rare diseases for patients, government backed payers, and private insurers. In this section Bob Glasgow of AmerisourceBergen will consider:
• What are the challenges in getting market access for patients?
• How can you prepare healthcare provider to know about the therapy and identify the right patients for the therapy?
• What challenges exist in getting the patient and various medical insurance schemes to pay for the therapy?
• What can be done to be proactive in monitoring side effects that can put patient safety risk?
Section Two: International shipping
With increasingly complex supply chain needs and an ever increasing emphasis on using risk as a major criteria in decision making, it can be difficult to prioritise each of the elements of international shipping, In this section Sue Lee of World Courier will consider:
• Contextualising risk for global shipping of Pharmaceutical
• How to juggle the elephants that international shipping can throw your way?
• Treat Tolerate Terminate or Transfer – how to choose which for best results?
• Case study of a risk assessment with suggestions on what to include and, as importantly, who to include, in your processes