Overview of The Regulatory Frameworks and Opportunities for Orphan Medicinal Products (OMPs)
Oct 6 2013 1:30PM - Oct 6 2013 5:00PM | Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road,
North Bethesda, MD 20852
The tutorial will describe regulatory frameworks from FDA and EMA and incentives for development of Orphan Medicinal Products (OMPs). It will cover details regarding incentives for developments of OMPs, opportunities and challenges. Additionally, this tutorial will give an overview of the different options to gather control data in rare/ultra rare disease settings. Case studies for requests for ODDs and marketing authorizations for OMPs will be presented and discussed.
Who Should Attend
Individuals involved in development and registration of OMPs, including regulatory intelligence
At the conclusion of the tutorial attendees should be able to:
- Identify the main features in the different Orphan legislations, recognizing opportunities and challenges in each
- Develop a regulatory strategy for development of OMPs and discuss the specificities of applying the general provision of the pharmaceutical legislative framework
- Discuss the ways health authorities have exercised regulatory flexibility to approve OMPs
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.