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topIn this Issue
 
  • Keynote Cheryl Michaels, who prepared for and responded to the 2014 SPU active shooting incident
  • John Sancinito, one of the leaders in the biomedical research threats intelligence field
  •  Barbara Grant, on anticipating and modifying your reactions in situations of personal conflict
  • Keynote Sholeh Ehdaivand (CEO and President, LMK Clinical Research Consulting), on preparing for an FDA audit
  • Mike Kassin (Florence Health Care), Remote monitoring
  • Raymond Nomizu JD (Co-founder/C0-CEO, Clinical Research IO) & Rick Arlow (CEO and President, Complion) on electronic regulatory compliance  
  • Stephanie Williams (Sr. Specialist, Regulatory Affairs, Cincinnati Children's Hospital), Overcoming the Barriers to Recruitment of Underrepresented Minorities.
  •  Dominic Chiarelli  (Manager, Legal Affairs, Quorum Review IRB) & Michelle Grienauer (Senior Regulatory Attorney, Quorum Review IRB), providing regulatory updates
  • Emily Gebbia, J.D. (Center for Drug Evaluation and Research) on CDER BIMO Compliance and Enforcement
     
Conferences and Member News
crisis Be prepared!  Attend the Security and Crisis Communications Conference

September 27, 2018
Alki Room at Century Square
8:30AM-4:30PM

We aren't all Scouts, but we can all be better prepared for external and internal threats that aim to unravel our physical and digital infrastructure, our safety and our intellectual property.
 
Keynote 
You probably remember the day in 2014 when you were gripped by news of the shooting at Seattle Pacific University (SPU).  So does Cheryl Michaels, because she was there in the middle of the SPU security response as Associate Director of Safety and Security.  Ms. Michaels will draw on her experience preparing for and responding to an Active Shooter incident. She will share lessons learned from this lived experience. Of note,  Ms. Michaels has been sought as a consultant by several NWABR members to support their plans for such scenarios.

Who Should Attend 
If you are a security professional, manage a laboratory, conduct research with animals or human volunteers, work within an animal facility, oversee the preservation of precious specimens...then this conference will be valuable to you;  you will be a valuable asset to other attendees as well.  We are stronger together.
 
Registration
This conference is designed to be rich with discussion and is therefore limited in the number of attendees.  We currently have about 30 seats remaining! Register here 
 
Agenda
Highlights of the day include Cheryl Michaels Active Shooter keynote, as above;
John Sancenito (Information Network Associates), who leads the preeminent US team gathering intelligence on potential threats to biomedical research, will provide up to date intelligence on threats we are all facing ; and Barbara Grant (CruxNW), one of Ken's personal mentors,will talk about preemptive responses to potential threats through the analysis of conflict and how our own personal responses to conflict can change the outcomes of the same. Finally, don't miss Ken's talk on social media policies in biomedical research.  For the current agenda please click here.   
 
 
clinical Come one, Come All! Clinical Research Professionals Conference

October 29, 2018
at Virginia Mason, Seattle 
 
NWABR's newest conference is in its second year!  We are once again co-presenting this conference with the Pacific Northwest Chapter of the Association of Clinical Research Professionals (PNCACRP).  With our partner we will offer material that is both timely and relevant, with high quality speakers. This conference is designed for clinical research professionals who have the role of ensuring the ongoing integrity of research within their institutions.

This conference is appropriate for those performing clinical trials, analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies  Curious if this conference is a good fit?  Please contact Ken Gordon directly at 206-957-3337.

Confirmed speakers and topics include:

Dominic Chiarelli (Quorum Review IRB) - Regulatory Updates
Michelle Grienauer (Quorum Review IRB) - Strategies for Ensuring Part 11 compliance
Mike Kassin (Florence Health Care) - Remote monitoring
Stephanie Williams (Cincinnati Children's Hospital) - Overcoming the Barriers to Recruitment of Underrepresented Minorities
Raymond Nomizu (Clinical Research IO) - eSource for sites
Rick Arlow (Complion) - E Regulatory Compliance
Wes Fishburne (Watson Health/Lifesciences)- Site uses of Clinical Trials Management System
Emily Gebbia (FDA) - CDER BIMO Compliance and Enforcement: What You Need to Know

 
OHRPOffice of Human Research Protections: Meeting New Challenges in Informed Consent in Clinical Research 
 
Livestream on Friday, September 7, 2018, 8:00 a.m. - 4:45 p.m. EDT
The HHS Office for Human Research Protections (OHRP) Exploratory Workshop is a new initiative to provide a forum for intellectual exchange within the research community on important issues related to human subjects protections. The workshop will bring together experts from diverse perspectives to discuss challenges for informed consent and innovative ways to address them.

(No registration required! International viewing supported.)

Sessions include
  1. Laying the groundwork for meaningful informed consent (8am-10:10am)
  2. Effectively presenting information to facilitate high-quality decision-making (10:25am-12:30pm)
  3. Pragmatic clinical trials (PCT) - challenges and innovations in getting informed consent (1:15-2:45pm)
  4. Delivery room research and the challenges for informed consent (3-4:45pm)
Learn more at the workshop webpage
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Jennifer Wroblewski | NWABR | (206) 957-3337 | engagement @nwabr.org | nwabr.org
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