03/13/12 (T) 9:00 am - 4:00 pm
Lennox Tech Enterprise Center, 150 Lucius Gordon Drive, West Henrietta, NY
This one-day seminar will provide an in-depth review of the latest FDA regulations and guidelines for applying Good Clinical Practice to the clinical research process. Participants will learn practical application of Good Clinical Practice guidelines that can be applied to clinical research supporting product development plans.
Experts will introduce key issues and trends in current GCP standards and regulations, including:
New IRB guidances and trends
Risk-based monitoring approaches (FDA Draft Guidance for Industry Oversight of Clinical Investigations, August 2011)
Clinical study design factors (FDA Draft Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices, August 2011)
GCP requirements for significant versus non-significant risk device studies
Risk management litigation considerations for human clinical trials
Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP
Lee Truax-Bellows is a founder, the president and the CEO of Norwich Clinical Research Associates Ltd. She has been involved in regulated research for the past 17 years and specializes in product development, GCP auditing and training on U.S. regulated research and good clinical practice. She is a family nurse practitioner with an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO. She sits on ACRPs Medical Device Forum Steering Committee and is president for the ACRP Central New York chapter.
Lorraine D. Ellis, M.S., M.B.A.
Lorraine D. Ellis founded Research Dynamics in 1993 to provide specialty clinical research services to the industry. During her 30 years experience in the pharmaceutical industry, she has worked in positions throughout the product development pathway from pre-clinical laboratories through Clinical Operations to Project Management. For the past 20 years she has developed and taught clinical research training programs to insure project quality and compliance to FDA/ICH standards to all types of professionals from monitors to CEOs and from Coordinators to Investigators. She was a member of the ACRP board of directors for 5 years.
James R. Cronmiller, M.A.
Jim Cronmiller is Chairman of the Rochester General Health System Clinical Investigation Committee, and also chairs the Institutional Review Board at Monroe Community College where he teaches Biology. He has taught at MCC as an adjunct and part-time temporary instructor since 2003, specializing in anatomy and physiology. Mr. Cronmiller has also taught similar courses at The College at Brockport. Previously, he was the director of research at Rochester General Hospital’s Gastrointestinal Unit.
Cynthia Weiss Antonucci
Ms. Antonucci is a Partner at Harris Beach PLLC. She is leader of the Mass Torts and Industry-Wide Litigation and the Insurance Litigation and Product Liability Defense Practice Groups and serves on the Medical and Life Sciences Industry Team. Selected among the Best Lawyers in America and listed in New York Super Lawyers, Ms. Antonucci brings a unique perspective and experience to the practice of law in the health care area. She was a former registered nurse at New York Hospital-Cornell Medical Center where she specialized in high-risk obstetrical care, including labor and delivery, operating and recovery room, and antepartal testing. She represents physicians, dentists and ancillary health care professionals such as nurse anesthetists, nurse midwives, physical therapists, and respiratory therapists before administrative tribunals and in high-exposure medical malpractice claims.
Who should attend:
Clinical Quality Assurance Professionals
Clinical Research Associates
GCP-Focused Regulatory Affairs Professionals
Professionals, Students and Graduates conducting clinical trials or seeking IRB approval
Participants attending the full workshop will receive a certificate of completion from MedTech.
In partnership with High Tech Rochester*
*All HTR clients will receive member registration rate
Register by Friday, February 24th for a discount!
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