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Roivant Sciences and Roivant Social Ventures (RSV) have partnered to host the Access to Medicines Internship and Fellowship Program, providing real-world drug development experience to talented PharmD students who are passionate about leveraging their career development to expand healthcare access to underserved patient groups. This summer Amanda Bowlin served as a Regulatory Strategy Intern for Roivant's Regulatory Affairs and Drug Safety (RADS) team. "It was my goal when entering this experience to find ways I could translate my personality and clinical knowledge to an impactful industry role. I feel passionately about increasing access to medicine and education to underserved patient groups..." "Through interactions with my family members from rural areas, and the patients I have worked with, I have become highly aware of the day-to-day barriers faced by underserved populations in relation to their health. Whether it is due to cost, transportation, access, adherence or other concerns, it is evident that having a desire to be healthy is not nearly enough given today’s medical system..." "This internship provided me with new perspectives on patient care, patient advocacy, and barriers to care. I now have a new understanding of how decisions at the early stages of drug development directly impact patients and a greater appreciation for both the challenges and exciting opportunities within expanding access to medicines.." During her RADS internship this summer Amanda: - Consolidated safety data across clinical trials from a clinical program and prepared adverse event tables for informed consent documents. - Assessed Roivant's clinical trial protocols in view of the International Council for Harmonisation (ICH) M11 guidelines on clinical study protocol templates and technical specifications. - Summarized key information from the FDA Summary Basis of Approvals for new drugs/indications. - Reviewed drug promotional guidance and crafted recommendations for external communications related to investigational drugs. Read more about Amanda's work experience and Roivant Social Ventures' 2024 Access to Medicines Internship Program here: https://lnkd.in/gr6EfAWX UNC Eshelman School of Pharmacy #regulatory #regulatoryaffairs #drugsafety #safety #research #healthcare #access #impact #medical #pharma #therapeutics #therapeutic #innovation #medicine #medicines #clinicaltrials #clinicaltrial #accessibility #healthcarenews #healthcareinnovation #raredisease