The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Course Description

This course discusses the legislative landscape and regulatory framework for novel treatments of rare diseases in the United States, European Union, and non U.S./E.U. regions.The significance and challenges of the Orphan Drug Act, rare disease advocacy, and the FDA’s commitment to rare diseases will be examined.

Topics:

1. Global Commission to End the Diagnostic Odyssey to Children with a Rare Disease
2. Trends in Rare Diseases and Orphan Drug Development
   • Orphan Drug Designations
   • Pharmaceutical manufacturer licensing agreements and acquisitions
3. Legislative Landscape in the U.S.
   • Orphan Drug Act (ODA)
   • Rare Diseases Act
4. Legislative Landscape in the E.U
   • Regulation (EC) No 141/2000 – the Orphan Regulation
5. Approvals before and after ODA and EU legislation
6. FDA’s Commitment to Rare Diseases
   • Office of Orphan Products Development (OOPD)
   • Rare Disease Program
7. Orphan Drug development challenges
8. Values and opportunities to bring Orphan Drug to market

Speaker:

Mladen Bozic, MS is Head & Vice President, Global Regulatory Policy and Intelligence at Shire, now part of Takeda since January 2019. He established Regulatory Policy and Intelligence function, including processes for effective internal regulatory policy activities, external representation and meaningful regulatory intelligence surveillance, assessment and dissemination. He has built an impressive network of external stakeholders in orphan space, including industry associations, senior regulatory agency officials, influencers in policy think-tanks and others, advancing Shire’s visibility and influence. Prior to joining Shire in 2012, he was with Abbott Laboratories/ Hospira in various commercial roles, from sales to price analysis and territory management. After leaving Abbott / Hospira, he joined Ovation Pharmaceuticals in regulatory affairs post-approval advertising & promotion and labeling, and in 2009 he was tasked to form a US regulatory policy and intelligence group. 

Mladen holds a BS in Nursing and pre-medicine from Duquesne University, and a MS in Regulatory Science / Bioscience from Johns Hopkins University.  bozic@usc.edu

Audience:

This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.

Learner Level: Intermediate/ Advanced

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 0.75 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the fifth course in a five (5) session program. To complete the entire program and earn a badge CLICK HERE.