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Our Story

A training package has been developed on the basis of the documents developed by ICH Steering Committee Members. We wish to thank to: Dr. Peter Arlett Head of Sector for Pharmacovigilance and Risk Management European Medicines Agency London UK Dr. Tomas Salmonson Medical Products Agency Preclinical and Clinical Investigation Unit Uppsala, Sweden Dr. Christine-Lise Julou European Federation of Pharmaceutical Industries Associations – EFPIA Brussels, Belgium Dr. Andrй W. Broekmans Schering Plough Research Institute The Netherlands Mr. Shinobu Uzu Ministry of Health, Labour & Welfare Tokyo, Japan Dr. Satoshi Toyoshima Pharmaceuticals and Medical Devices Agency (PMDA) Tokyo, Japan Mr. Kazutaka Ichikawa Japan Pharmaceutical Manufacturers Association – JPMA Tokyo, Japan Mr. Kohei Wada Asia Clinical Development Department Daiichi Sankyo Co., Ltd. Tokyo, Japan Dr. Justina A. Molzon Center for Drug Evaluation and Research (CDER) Food and Drug Administration Rockville, MD, USA Dr. Robert A. Yetter Center for Biologics Evaluation and Research (CBER) Food and Drug Administration Rockville, MD, USA Dr. Alice Till Science Policy and Technical Affairs Pharmaceutical Research and Manufacturers of America – PhRMA Washington DC, USA Dr. Peter K. Honig Worldwide Regulatory Affairs and Product Safety Merck Research Laboratories North Wales, PA, USA Mme Alicia D. Greenidge International Federation of Pharmaceutical Manufacturers Associations – IFPMA Geneva, Switzerland Dr. Odette Morin Director of Regulatory and Scientific Affairs International Federation of Pharmaceutical Manufacturers Associations – IFPMA Geneva, Switzerland Mr. Mike Ward International Policy Division Bureau of Policy and Coordination Therapeutic Products Directorate Health Products and Food Branch Health Canada Dr. Lembit Rago Quality Assurance and Safety : Medicines HTP/EDM/QSM World Health Organization Geneva, Switzerland Dr. Petra Doerr Swissmedic, Swiss Agency for Therapeutic Products Berne, Switzerland Trainers for Eastern European countries: Dr. Werner Gielsdorf, HSC- Germany General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC , EU, World Bank, UNCTAD/WTO, trainer of GCP, GLP, GDP,GMP Dr.Zadorin Eugene, PhD, MBA International BioPharmaceutical Association, , Gerson Lehrman healthcare Council, First Clinical Research LLC Speakers Bureau, former head of consulting Group of the Department of Clinical Research of State Pharmacological Center of MOH of Ukraine ( 2006-2008 ). Accreditation International accreditation has been requested from: HSC-Germany ,NBScience GCP certification GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. The NBScience’s certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam. Program: “Main principles of Good Clinical Practice (GCP). Regulatory acts of the European Union and International Conference of Harmonization (ICH). Responsibilities and the rights of the parties participating in clinical trials. Interaction of Sponsor and Investigator. Responsibilities of Investigator, Sponsor according to principles of Good Clinical Practice (GCP)” “Ethical aspects of clinical trials of medical products. Informed consent . File of Investigator; keeping of documentation.” „Legal and regulatory base of clinical trials of medical products in Europe. FDA and EMEA. The basic requests to the documentation for clinical trials of medical products.” “Regulatory inspections of FDA and SPhC. Types of inspections. Responsibilities of Sponsor, Investigator and Inspector at the time of audits.” “Specific clinical trials and GCP regulations in your country” Testing. GCP certification.