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Meet the Authors: Orphan Drug Development for Rare Diseases

1.0 RAC Credits Price: $0
Meet the Authors: Orphan Drug Development for Rare Diseases

The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development, including:

  • History
  • Incentives
  • Benefits
  • Patient engagement
  • Orphan drug designation
  • Marketing authorization
  • Market access

The authors will explore the critical role patients and patient advocacy groups play, examples of several active rare disease organizations, and the latest regulatory tools, resources, and practices for developing orphan drugs, and how to apply them. They will address how a company can reduce its financial burden in the drug development process by taking advantage of grants, involving academia, and working with patients early in the process.

Register for this free, live broadcast and learn about challenges facing the developer and strategies to overcome them.

 

Learning Objectives

Learn about challenges facing the developer and strategies to overcome them, including:

  • Adopting the applicable regulatory guidance
  • Involving patients
  • Reviewing precedent and case studies

 

Speakers

Sundar Ramanan, PhD, MBA

Just-Evotec Biologics

 

Sunny Kamlesh Dave

MPharm

Novo Nordisk

 

Event Policies

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

 

Contact Us

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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