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.

Description:

The importance of the FDA Patient-Focused Drug Development policy will be discussed, including patients’ perspectives in determining the risk/benefit in areas of high, unmet medical need; and the role of a patient advisory committee for drug approval. Additionally, consideration on how this policy was scrutinized during drug approval evaluation for the treatment of rare disease.

Topics:

1. Introduction and Background
   • Prescription Drug User Fee Act (PDUFA)
   • FDA Patient-Focused Drug Development Guidance Series for Incorporation of the Patient’s Voice
2. Policy Analysis
3. Patient Advocacy Organizations
   • Sarepta Case
4. Impact Analysis
   • Positive Aspect

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

Learner Level: Intermediate/Advanced

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.

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 1.0 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 second course in a five (5) session program. To complete the entire program and earn a badge CLICK HERE.