13th Global Pharmacovigilance & Clinical Trials Summit March 28-29, 2019 Osaka, Japan

Rhodes Pharmaceuticals,USA

Pharma Consultancy

Dr. Ashok Srivastava is Chief Executive Officer and Chief Medical Officer of Cure Pharmaceuticals, and ClinFomatrix Oncology CRO, He was founder, Chief Executive Officer and Chief Medical Officer of Care Beyond - A Radiation Therapy Cancer Center, New Jersey. USA. He has more than 15 years of experience in drug development, medical affairs and commercialization of cancer drugs including radiopharmaceutical and supportive care; Phase 1 – 4, and marketing commercialization of Hematology, Oncology and radio-immuno-oncology drugs in USA, EU and Japan. He is leader in Cancer Drug Development Worldwide large and complex Phase 3 Clinical Trials. He contributed to 21-INDs and 7-NDAs of Cancer Drugs, acquisition /merger of company and drug for more than $900 million. He received his clinical, medical training & worked at renowned medical centers and pharmaceutical institutions worldwide at various executive leadership positions; Walter Reed Army Institute of Research and Medical Center, Daiichi Pharmaceuticals, Sumitomo Pharmaceuticals, Pharmacia, Pfizer, Eisai Oncology, Spectrum Pharmaceuticals and Taiho Oncology. He received his Clinical, Medical & Business educations from All India Institute of Medical Sciences, New Delhi, India; Academy of Medical Sciences, Czechoslovakia; School of Medicine Nagasaki University, Japan, and Pharmaceutical Business at Rutgers University Business Management, New Jersey, USA. He played key role in dramatic expansion of oncology drug – developed cancer drugs- Sutent (Sunitinib), Evoxac (Cevimeline HCl), and liposomal doxorubicin (Myocet) in combination with Herceptin & Paclitaxel for HER2 positive for metastatic breast cancer patients and Latuda (Lurasidone) for schizophrenia. He has published more than 85 papers in National and International Journals, more than 120 abstracts, 3 book chapters and 2 patents. He is recipient of numerous National & International prestigious medical awards and recognitions from United Nations, Ministry of Health, Japan, and Department of Army, Walter Reed Army Medical Center and Walter Reed Army Institute of Research, Washington DC, USA. He served as medical advisor to Poniard Pharmaceutical for small cell lung cancer and Taiho Oncology in USA, EU and India. Dr. Srivastava is member of numerous prestigious organizations; America’s Top Oncologist of the years 2017, Breast Cancer Foundation, Indian Society of Oncology, American Society of Clinical Oncology, American Society for Therapeutic Radiology & Oncology, American Association of Cancer Research, and International Society of Lung Cancer. Dr. Srivastava is a strategic medical advisor and Board Member to several pharma in USA for clinical, regulatory and supervises cancer drug development. Recently Dr. Srivastava was awarded membership of Japan External Trade Organization, USA. Dr. Srivastava is a Leader in Drug Safety, pharmacovigilance of Oncology, hematology, immuno-oncology and built global drug safety and pharmacovigilance companies in USA, and India. Dr. Srivastava was invited as an honorable speaker at drug safety & Pharmacovigilance congress in London, UK, India and Washington, DC, USA in 2017. Dr. Srivastava brought 2 cancer drugs & a vaccine in global market for approximately 3 – 3.5 billion $ in global sales. He serves as board of directors for oncology pharma companies in USA.

Global complex mega cancer drug trial & generic drugs drug development and medical affairs R&D & medical affairs; Phase I-IV and Life Cycle Management Chemotherapy, Immuno-oncology, Supportive Care Alliance Management/Joint Steering Committee Building High Performing Teams

Ettore Napoleone is a Paediatrician, President of FP-MCRN Onlus, member of Coordinating Group of ENPR-EMA (European Network Paediatric Research at the European Medicines Agency) and member of ENCEPP. He was educated at the “ La Sapienza” Rome University (postgraduate degree-cum laude- in Pediatrics in 1989). Research Fellow - Paediatric Diabetes Center – I° Paediatric Clinic - University “La Sapienza “ Rome) and Research Fellow C.N.R. ( National Research Council ) (1987).He is an effective Member of ASREM Ethic Committee. Since 1990 he works as a Primary Care ( Family) Pediatrician in Campobasso.Italy His research interests include all paediatrics and the medicines for children (Efficacy Clinical Trials and PASS) He holds membership in professional organizations, including S.I.P. ( Pediatric Italian Society) E.A.P. (European Academy of Paediatrics) and S.I.R.P. ( Pediatrics Italian Research Society) He is author of more than 100 scientific national and international papers, Member of Scientific Committee, Speaker and Chairman in National and International Scientific Congresses, Referee of peer-review journals.

Pediatrics and the medicines for children

Chi Chen is a forensic technology partner in EY’s Forensic & Integrity Services practice. He specializes in predictive risk analytics, proactive compliance monitoring and management systems, trade compliance, data compliance, IP and personal data privacy protection, fraud detection analytics, antitrust analytics, and eDiscovery. All of which require in-depth analysis of large, disparate sets of financial, operational and transactional data. Chi led his team to help clients identify high risk transactions or behaviors timely, efficiently, and effectively by leveraging advanced data analytics techniques including but not limited to data visualization, statistical modeling, text mining, and machine learning. Chi has more than 16 years of combined advisory and audit experience in the United States, Australia and China. He has served many Fortune 500 and multinational companies in a variety of industry sectors including life sciences.

information governance and data compliance

Pharmacist-Biochemistry graduated from USP in 2005, Sanitary Surveillance Management Specialist (IEP-HSL/Anvisa/MS) and Health Technology Assessment Specialist (Institute of Education and Sciences/HAOC/MS) MBA in Economy and Health Technology Assessment File/FEA/USP (2015-2016). Post-graduated professor in Drug Safety and Regulatory Affairs.

Biochemistry

He is the Senior Director and head of Global Pharmacovigilance at Cipla. He is a Senior Manager, Strategic Planning and Pharmacovigilance Operations, Supplier performance Management at Amgen. A Medical Doctor and a certified Project Management Professional PMP.I have done my M.Phil. in Biostatistics and I am involved in Drug Safety and risk and Managemen. He have done Executive Program in Strategic Management from IIM Rohtak. He have 16 years of total experience which includes 6 years of direct patient care experience as a doctor in various capacities including Medical / Cardiac / Post-surgical ICU and 11 years of experience in pharmaceutical industry in various functions like Pharmacovigilance, BA/BE and Medical Affairs/Medical Information. My experience as a physician is well utilized in safety and risk management activities. He have hands-on experience in managing and leading a pharmacovigilance department in a pharmaceutical company and the activities therein viz. initiating and designing SDEA's, SLA's, all aspects of ICSR case processing, Medical review of ICSRs, Medical and Safety review of aggregate reports, Benefit-Risk analysis reports, Signal detection and interactions with regulatory authorities. He have worked with pharmaceutical companies and pharmacovigilance service providers enabling me to view issues from both sides of the table.

Pharmacovigilance & Drug Safety Biostatistics Clinical Research, BA/BE Internal Medicine

He is completed his Doctor of Medicine in 1997 in Thammasat University and he studied family medicine in The Royal colleges of Family Physicians of Thailand. In 200, he is a medical lecturer of Basic Pharmacology and clinical Pharmacology and Doctor of Medicine in clinical practitioner for chulalongkom university staffs for the department of pharmacology, faculty of medicine, Chulalongkorn university. In 2013, He worked as Product Physician (Medical Advisor) in Pfizer (Thailand) Ltd. He served as Researcher and program Manager in department of Thai traditional and alternative medicine, ministry of public health. 2014 – 2018 Physician in Vichaiyut hospital department of internal medicine. He Honored and Awarded for an outstanding Biological sciences study, The Sciences Society of Thailand under the Patronage of H.M. the King.

Systematic program and technology implementation for the elderly physical and mental health: Global health development of the quality of living by the innovative technology of health care.Ubiquitous Healthcare (focusing on health data management and electronic medical information for the aging)

Md. Gayoor khan has Perusing his Bachelor of Pharmacy at the University TRUBA INSTITUTE OF PHARMACY Bhopal Madhya Pradesh. He is the founder & National President of NFPS, a Globally Working organization. He has published more than 17 papers in reputed journals and has been serving as a liaison officer USM Malaysia, CEC Member IHPA- SF, Business Associate kp Lab's, President GOMHA Student wing, Project Manager in health care department at Clyto access Pvt,ltd , Training Associate in clinitech.

Pharmacovigilance,Pharmacy,Clinical Trials