Dr. Moshe Tzvi Neuman
Dr. Moshe Neuman, Founder and Managing Director of Bio Medical Research Design Ltd. (B.R.D), a leading Israeli regulatory affairs consulting Firm, focused on providing professional expert advice and integrated Contract Research Organization (CRO) services to Israeli startup companies at the early stage development, in the fields of pharmaceutical, biotechnology, medical devices, and other medical-related industries.
Dr. Neuman is a life scientist by background and holds a Ph.D. degree in Physiology & Pharmacology from Tel Aviv University Medical School. He has studied regulatory affairs and clinical trials conduct in advanced courses in the US and the EU.
He has extensive research and management experience gained in senior positions at the Life Sciences Research Israel (LSRI) division of the Biological Research Institute and the Neufeld Cardiac Research Institute, Sheba Medical Center as a member of its founding team.
Dr. Neuman is closely familiar with the field of research & development of medical products, and has over 24 years of practical experience in a wide range of innovative projects and technologies in the pharmaceutical and biotechnology environment. He has gained well established experience and expertise in project management of the processes associated with diverse medical products development in compliance with the international global regulatory requirements such as ICH, FDA and EMA health authorities’ regulation, essential for their marketing approval or CE certification.
Most recent, Dr. Neuman joined the expert team of the “SPARK HUJI” Program (a subsidiary of Stanford University SPARK program US) of the Hebrew University of Jerusalem Medical faculty and at the Tel Aviv University Biotechnology faculty, to provide regulatory affairs consulting to the selected unique projects of their new biotechnology innovation accelerators.
Dr. Neuman is also a Senior Clinical Research Professional and has extensive CRO experience in management clinical research design and conduct. He has led numerous phase I-IV clinical trials, both; local and international for a variety of pharmaceutical, biotechnology and medical device companies. He has extensive hands-on working experience and knowledge of ICH GCP and FDA clinical trials guidelines as well as with various therapeutic areas and disease models.
Dr. Neuman is the leading ICH GCP training provider for numerous medical centers staff, CROs, startups, and has designed and delivered GCP training programs at the medical faculties of the Tel Aviv University, Ben Gurion University and University of Haifa as well as at other medical educational institutions and organizations across Israel. To date he has trained several thousands of members of the community engaged in clinical research, among them many ethics committees members, investigators, study coordinators and CRAs in Israel. Dr. Neuman’s ICH GCP training course have been updated to include ICH E6(R2) guideline and was identified by TransCelerate BioPharma to meet the international criteria as necessary to enable mutual recognition of its GCP training certificate among trial sponsors worldwide.
Dr. Neuman is an experienced certified international auditor for clinical trials and accomplished numerous GCP site audits, CRO audits and vendor qualification audits in Israel and the EU. He serves as a senior consultant and a member of the Hospitals Division Central Audit Team at “Clalit” Health Care, responsible for managing and conducting GCP audits at all 14 “Clalit” Health Care Medical Centers in Israel on a routine annual basis. As part of his job he authored in 2006 the “Procedures & SOPs IRB Guidebook” governing the IRB activity at all 14 “Clalit” Health Care Medical Centers in Israel.
Dr. Neuman is using his knowledge of ICH GCP and international best practice as well as his vast auditing experience to influence the streamlining and standardization of clinical research-related processes in Israel. He is involved in discussions of various forums of the Department of Clinical Trials of the Israeli Ministry of Health, and he is also an active participant in the deliberations of these issues at the Health Committee and the Science Committee at the Israeli “Knesset”.