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A Medical International Consulting, current Member of the ANRS MIE Pandemic Contingency Plan for Emerging or Re-emerging Infectious Diseases Keynote on EXPERTISE AREAS–Background and Motivation: Trained as a Medical doctor including in internal medicine and epidemiologist, I have more than 20 years of experience in managing national and international clinical trials, both as an investigator and as a sponsor's representative. I have medical and scientific expertise in oncology, infectious diseases and emerging infectious diseases, pediatric specialties, neuroscience and cardiology. I am currently Head of the Global Vigilance and Participant Safety Department of ANRS | EID and Inserm | PRC. I have completed my M.D. degree from the Medical University of Oran, Algeria, followed by a number of interuniversity diplomas in France. I have a Master's degree (Universities of Paris) in Public Health and in Clinical Pharmacology. Before joining ANRS in 2006, I practiced in the Medical Oncology Department of the Tenon Teaching Hospital in Paris. As Chief Senior Manager and Director of the Global Vigilance Department over 16 years of experience, my group and I have been working to consolidate international clinical collaboration on research initiatives by ensuring better safety for participants enrolled in clinical trials. I have developed with my team a centralized pharmaco-vigilance system for the platform clinical trials during the covid-19 pandemic and the pan-European clinical trials network called c4c: conect4children and more recently with the Mpox outbreak. As a safety working group leader and vaccine safety specialist, I am currently leading several safety expert groups in vaccine development including Ebola (PREVAC in Africa), HIV (VRI and EHVA: France and Europe) and covid-19 (Covicompare program: France and Africa. I am an academic researcher and university lecturer at several pharmacy and medicine faculties, the Pasteur Institute of Paris, the Vaccine Research Institute Creteil Paris. I am an expert in drug safety and regulatory science; I am actively involved in the training of physicians and investigators in LMIC. I am co-authored more than 100 publications in peer-reviewed journals and a frequent speaker at national and international meetings. My research interests include clinical pharmacology, antimicrobial resistance, drug safety, vaccine safety and co- morbidities, pharmacokinetics, HIV, viral hepatitis, TB and EID. I am a member of numerous national and international committees, advisory groups and clinical trials network groups. I am currently the representative of ANRS | EID in the Glopid-R funders clinical trials network group. I am also a member of the French Academic Sponsors Group, the French Pediatric Network, the EU Response Consortium, and a member of numerous leading medical and scientific organizations and associations. During the Covid-19 pandemic, on behalf of IMG (NGO of Guinean health workers), I organized a webinar in Guinea (February 2022 in Conakry) on the lessons learned with 98% Guinean experts as speakers worldwide. In addition to my medical and scientific background, I have extensive experience in administration, personnel management and evaluation, board and scientific council meetings, coordination of research programs and project management, institutional communication, relations with governments, regulatory agencies, policy makers and many technical and financial partners (public and private), foundations, research agencies, research funding agencies, and bilateral cooperation within the ANRS | MIE and Inserm network including in the African health sector . As researcher (Inserm Research Fellow CR1): As a researcher, I lead the ANRS-EID coordinated action on mother-to-child transmission in order to stimulate transversal and innovative projects in this field. As an epidemiologist by training, I have extensive experience in regulatory affairs, medical affairs, drug development, including clinical trials for vaccine development, and have authored over 120 scientific publications, including over 100 peer-reviewed papers published in top-tier scientific journals. I currently lead a group of over 18 drug safety experts within ANRS-EID and over 15 outside my institutions. As an expert in regulatory affairs, I have managed a number of early phase clinical trials, including the first in humans, in oncology and most importantly in infectious diseases and EID (list available upon request). Having graduated from one of the most advanced training programs in Vaccinology, ADVAC, I am a member of the innovative Vaccine Development Program with ANRS | MIE. As expert in public health, global health and pandemic preparedness: I am an expert in public health policy program implementation including health systems analysis, health policy, management and global health with pandemic research preparedness. I have advised number of international partners on how to build pharmacovigilance system, national health authorities. As an expert in capacity building and knowledge transfert: I am the leader of the ANRS | MIE group for strengthening capacity building, knowledge transfert on clinical trial sponsorship. Transfer of knowledge is ongoing with several partners on how to build a pharmacovigilance system and particularly in AFRICA. I am actually conducting a transfert in clinical trial sponsorship for the LMIC countries in the context of Integrate, Lassa fever clinical trial. As an ANRS | EID coordinator of the scientific research group: Scientific animation/brainstorming is one of the pillars of ANRS | MIE, I am piloting the Coordinated Action on Mother-to-Child Transmission regardless of the pathogen. With the presidents of this Coordinate action, we are keen to bring to fruition important, large-scale, multi-disciplinary and structuring projects. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level [Job Title] position. Ready to help team achieve company goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Seasoned nursing professional offering proven clinical knowledge, natural interpersonal strengths, and technical abilities. Knowledgeable about EMR charting, medication administration, and interdisciplinary collaboration focused on optimizing patient care and support. Quality-focused and efficiency-driven leader. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Experienced Registered Nurse with 8 years specializing in renal and critical care. Demonstrated ability to deliver exceptional patient care through clinical expertise, leadership, and technical proficiency. Skilled in medication monitoring, patient charting, and collaborating with healthcare teams. Committed to enhancing patient outcomes through clear communication and compassionate treatment.
Recent graduate with foundational knowledge in clinical research and hands-on experience gained through academics. Demonstrates strong teamwork, problem-solving, and time-management skills. Prepared to start career and make meaningful contributions with commitment and drive.

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Team Player and Leader in HealthCare Administration and Clinical Medical / Scientific Liaison

ROHITH NELAKURTHI

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