Medidata Solutions Leads Global Education on Clinical Data Management, Standards and Safety at DIA Industry Events.VP of Global Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: to Present at DIA Conferences in India and Canada NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Medidata Solutions continues to drive discussion at key industry events around critical topics in the e-clinical space, as VP of Global Regulatory Affairs and Quality Assurance Earl Hulihan is scheduled to present at two upcoming Drug Information Association (DIA) events in India and Canada. A global provider of electronic clinical data capture, management and reporting solutions, Medidata Solutions' Rave[R] platform streamlines trials for the world's largest pharmaceutical companies, biotechnology, medical device, and research organizations. In October, Hulihan will be delivering the following two presentations: 2006 DIA and Institute of Clinical Research (India), ICRI ICRI International Coral Reef Initiative ICRI International Concrete Repair Institute ICRI Institute of Clinical Research (India) ICRI Interdisciplinair Centrum Voor Recht En Informatica co-sponsored, Drug Discovery and Clinical Development in India: Opportunities and Challenges - October 15-18, 2006 - Mumbai, India GCP GCP Good Clinical Practice GCP Ground Control Point GCP Global Carbon Project GCP Gateway Control Protocol GCP Global Consciousness Project GCP Granulocyte Chemotactic Protein GCP Grand Central Parkway (New York) , Data Protection and Electronic Records: How Do They Fit Together October 15, 9:00 a.m. In this workshop, attendees will learn about the state of good clinical practice in India, best practices in data protection and ensuring source records comply with global regulatory standards. Also discussed will be the roles of electronic data capture versus traditional paper CRFs, sourcing in clinical trials devoted to India and Asia, and how clinical trials and data management of clinical trials are connected in providing data with full integrity. DIA's 4th Annual Canadian Meeting - October 29-31, 2006 - Ottawa, Ontario The Evolution of Safety Monitoring Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. and a Look to the Future October 31, 10:15- 11:45 a.m. This session will provide an overview of the state of post marketing surveillance after a drug is approved. Attendees will review the evolution and direction of the industry, highlighting data management and foreshadowing fore·shad·ow tr.v. fore·shad·owed, fore·shad·ow·ing, fore·shad·ows To present an indication or a suggestion of beforehand; presage. fore·shad adverse effects. In addition, Hulihan will chair and present during the Track 2 discussion at this time, focusing on safety and pharmacovigilance. Discussion will include the reporting and analysis of spontaneously reported adverse events, their possible replacement by new sources of safety information, the future of spontaneous adverse events databases, and the future of Periodic Safety Update Report reviews. About Earl Hulihan Hulihan brings more than 30 years of experience in quality assurance, regulatory compliance, drug development and clinical research to his role as vice president of global regulatory affairs and quality assurance at Medidata Solutions. Prior to joining Medidata Solutions, Hulihan served as the senior vice president of regulatory consulting services at META Solutions Inc. and vice president of quality systems at EduQuest. In both roles, Hulihan provided regulatory consulting, auditing and training services to the global pharmaceutical, biologics and medical device industries. He has also provided advice and training to regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. personnel within the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and European community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. and has more than 15 years of experience in clinical medicine as a research specialist, teaching specialist, clinical physiologist, and investigator. Hulihan serves on the DIA Advisory Council for North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and as chair of the DIA Validation Global community. About Medidata Solutions Worldwide Medidata Solutions helps the world's leading pharmaceutical, biotechnology, medical device and research organizations maximize the value of their clinical research investments. Innovative process design, technology and services streamline clinical trials by providing early visibility to reliable clinical data - the lifeblood life·blood n. 1. Blood regarded as essential for life. 2. An indispensable or vital part: Capable workers are the lifeblood of the business. of every research organization. Working with companies and institutions both large and small, Medidata Solutions helps clinical researchers safely accelerate the process of bringing life-enhancing treatments to market - on five continents and in more than 70 countries. Medidata Solutions brings significant value to its broad client base with deep clinical experience and expertise in more than 20 therapeutic areas, projects in Phase I, II, III, IV, registries and surveillance, and studies with thousands of investigators and tens-of-thousands of subjects. For more information, please visit www.mdsol.com. |
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