WIRB–Copernicus Group to Co-present Fifteen Sessions at Public Responsibility in Medicine and Research Conference

PRINCETON, N.J., Nov. 08, 2016 – WIRB-Copernicus Group® (WCG™), one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, announced today that eight of its thought leaders are presenting during 15 sessions at the Public Responsibility in Medicine & Research (PRIM&R) Advancing Ethical Research (AER) 2016 Conference, which is being held Nov. 13-16 in Anaheim, CA.

“We are pleased to contribute to the educational experience for PRIM&R attendees in such a significant way this year. A wide array of experts from our compliance, quality, and medical groups will share their knowledge and experience with other industry professionals, thus helping to ensure the welfare of research participants,” said WCG Chief Medical Officer Lindsay McNair, MD, MPH, MS Bioethics.

The following PRIM&R sessions will be co-hosted by WCG thought leaders:

Sunday, Nov. 13
Pre-Conference Workshops
8:30 a.m. – 4:30 p.m.
“Ethical and Practical Issues In Global Human Research” – David Borasky, MPH, CIP
(Vice President, Quality Management, WCG)

8:30 a.m. – 4:30 p.m.
“Single IRBs Are Here: Are You Ready?” – David Forster, JD, MA, CIP, (Chief Compliance Officer, WCG)

Monday, Nov. 14
2:30 – 3:45 p.m.
A1 – “A Dialogue with the Secretary’s Advisory Committee on Human Subject Research Protections (SACHRP)” – David Borasky, MPH, CIP (Vice President, Quality Management, WCG); David Forster, JD, MA, CIP, (Chief Compliance Officer, WCG); Julia G. Gorey, JD

A2 – “Staying on Top of Your Game: Professional Development for Human Subjects Protections Staff” – Charlotte Coley, MACT, CIP (Board Member, Copernicus Group IRB); Hila F. Berger, MHP, CIP; Karen M. Hansen

4:00 – 5:15 p.m.
B1 – “Evaluating Members, Chairs, and Staff: What Works and What Doesn’t?” – Yvonne Higgins, CIP (Vice President, Quality Management, Copernicus Group IRB); Robert W. Franck Jr., MD

B2 – “Ensuring Research Compliance of Multicenter and International Research” – David Borasky, MPH, CIP (Vice President, Quality Management, WCG); Edward E. Bartlett, PhD; Leslie M. Howes, MPH, CIP; Lama Jamhawi, MSc, CIP

Tuesday, Nov. 15
11:15 a.m. – 12:30 p.m.
C1 – “Crossing the Line: When Does Innovative Care Become Research?” – Lindsay McNair, MD, MPH, MSB (Chief Medical Officer, WCG); George Gasparis, CIP

C2 – “Recruiting, Educating, and Retaining Non-Scientist/Community IRB Members” – Charlotte Coley, MCAT, CIP (Board Member, Copernicus Group IRB); Michelle M. Feige, MSW, LCSW-C; Gianna McMillan, MA

3:30 a.m. – 4:45 p.m.
D1 – “Ethical Issues in Patient-Led and Crowdsourced Clinical Research” – Lindsay McNair, MD, MPH, MSB (Chief Medical Officer, WCG); Chiauzzi, PhD

D2 – “The Seven Habits of Highly Effective and Flexible IRB’s” – Jeff Cooper, MD, MMM (Vice President, Process and Strategic Improvement, WCG); Martha F. Jones, MA, CIP; Ernest D. Prentice, PhD

Wednesday, Nov. 16
9:45 – 11:00 a.m.
Panel VII “Amplifying the Challenges: Return of Results in Pediatric Research” – David Forster, JD, MA, CIP, (Chief Compliance Officer, WCG); Albert J. Allen, MD, PhD; Celia B. Fisher, PhD; Jill McNair, MBA

11:15 a.m. – 12:30 p.m.
E1 – “Unanticipated Problems (UPs) and Adverse Events (AEs): A Practical Approach for IRBs” – Jeff Cooper, MD, MMM (Vice President, Process and Strategic Improvement, WCG); Lisa R. Buchanan, BS, MAOM; Sarah Marie Huban, BS, MA, CIP, CHRC

E2 – “IRB Chair Responsibilities and Roles: Beyond the IRB Meeting” – Patience Stevens, MD, MPH, CIP (Vice-Chair, Copernicus Group IRB); J. Andrew Bertolaus, MD; Elizabeth S. Moore, PhD

E3 – “Scientific Aspects of Study Design: A Primer for Non-Scientist IRB Members” – Lindsay McNair, MD, MPH, MSB (Chief Medical Officer, WCG); Susan S. Fish, PharmD, MPH

E4 – “When Exception Does Not Apply: Practical Strategies for Ethical Enrollment of Situationally Impaired Subjects in Clinical Trials in the Emergency Setting” – Ronald Malo, DO, MS (Board Member, Copernicus Group IRB); Neal Dickert Jr., MD, PhD; Robert Silbergleit, MD

WCG experts will also be available to answer attendee questions in the exhibit hall. Two of WCG’s companies, Western Institutional Review Board® (WIRB) and IRBNet are sponsors of the conference, and will have a presence at booths #202 and #210, respectively.

Founded in 1968, WIRB was the first independent review board and the pioneer of ethical review. It is now the trusted partner for more than 2,100 institutions in the U.S. alone. IRBNet provides compliance and research oversight solutions for institutions, supporting more than 2,300 research sites and review boards and more than 230,000 research professionals.

For further information about the PRIM&R AER conference, please visit http://www.primr.org/aer16/

About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research. The industry’s first Clinical Services Organization (CSO), WCG enables biopharmaceutical companies, CROs and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections.

WCG solutions include contract and budget negotiation, study start-up acceleration, regulatory and ethical review services, oversight of research involving gene therapy, and lab safety consulting. Powered by a suite of proprietary technologies, WCG solutions help clients to increase regulatory compliance and support the digital management of clinical trials. For more information, please visit http://www.wcgclinical.com or follow us on Twitter @WCGClinical.

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