New York State
New York State SOCRA Chapter Fall Program
Friday, November 9, 2018
8:00-8:30 Sign-In; 8:30 - 3:30 Program
Welch Allyn Lodge, 4355 State Street Rd, Skaneateles Falls, NY
8:00 - 8:30 Sign-In and Network Opp
8:30 - 8:40 Welcome and Introduction
Kathi Durdon, MA, CCRP, SoCRA NYS Chapter Chair, Director of Operations, CNY Biotech Accelerator at Upstate Medical University
8:40 - 9:40 Medical Device Quality Management Systems
Terrence Howell, MBA, Director, Quality Affairs for Research,
Research Administration, Upstate Medical University
Abstract: This session will give an overview of medical device quality and regulatory requirements forboth ISO and FDA to include looking at the history of medical device regulation. This presentation will also outline the requirements for quality systems using a risk-based approach. We will also discuss roles and responsibilities moving forward as new regulations take effect.
9:40 - 10:40 Patient Registries
Kayt Marra, MA, CD-N, CCRP, Dietician and Case Manager, Section of Genetics & Metabolism, Albany Medical Center
Abstract: As of March 27, 2018, NIH listed 57 different patient registries for a variety of diseases and disorders which the site notes is not complete. Registries are often birthed through collaboration between non-profits and institutions looking for a cure for a particular disease, sponsored by government entities tracking long-term health outcomes in a targeted population, and in some cases as a requirement following rare disease drug approval to monitor outcomes after the market release. This presentation with review different types of registries, new collaborations in registry data collection, and lessons learned while working on an industry sponsored post-market registry for a rare disorder medication used to treat PKU.
10:40 - 11:00 Networking Break
11:00 - 12:00 Cancer Vaccine Research Case Study
Rachel Evans, Roswell Park Cancer Institute
Abstract: The ongoing collaboration between Roswell Park Comprehensive Cancer Center (Buffalo, NY) and Center of Molecular Immunology (Havana, Cuba) highlights the importance of international collaborations in the biotechnology field. This presentation highlights the shared mission of the collaboration along with opportunities and challenges that have been faced along the way. The purpose is to discuss the development of this collaboration from the Center of Molecular Immunology investigations through the opening of a phase 1 clinical trial in the United States at Roswell Park with therapies developed in Cuba. This collaboration was responsible for the first clinical trial of CIMAvax-EGF involving advanced stage non-small cell lung cancer patients in the USA.
12:00 - 1:00 Networking Lunch
1:00 - 2:00 Misconduct, Fraud, and Serious Breaches of GCP: What Is It and What Must We Do About It?
Lorrie D. Divers, President, QRCP Solutions, Inc.
Abstract: This session will provide a review of US and European regulations and guidance regarding scientific misconduct, fraud and serious breaches of GCP. Roles and responsibilities of sponsors, CROs, and clinical investigators will be described. Using specific scenarios, the audience will discuss how to recognize it, determine if the scenario meets the criteria for reporting, and discuss what other actions may be indicated.
2:00 - 3:00 Budget Basics and Beyond - Bang for Your Buck
Lin Feng, Clinical Research Coordinator, Buffalo Institute for Medical Research
Abstract: Performing industry-sponsored studies is becoming harder than ever. A fair and balanced budget ensures your costs and effort are adequately covered. Learn how to identify costly protocol pitfalls, negotiate per patient costs as well as fixed and hidden fees.
3:00 - 3:30 Program Q&A
If attending in person, a catering fee of $43.00 will be collected by the The Lodge (site catering vendor) on the day of the program.
If attending via conference call-in - please note this on the Attendee Form.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area." SOCRA members may be credited for (up to) 5.5 hours Continuing Education Credit Hours for their attendance. SOCRA members should claim only those hours of credit that he/she actually spent in the educational activity.
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