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How Does the Recent ICH-GCP E6 Update Affect YOU?

Northern California Chapter (SF Bay Area) - Association of Clinical Research Professionals (ACRP)

Thursday, June 15, 2017 from 6:00 PM to 8:45 PM (PDT)

How Does the Recent ICH-GCP E6 Update Affect YOU?

Ticket Information

Ticket Type Remaining Sales End Price Fee Quantity
NCC Chapter ACRP member   more info 24 Tickets Jun 8, 2017 $5.00 $0.00
ACRP member and public   more info 24 Tickets Jun 8, 2017 $30.00 $0.00

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Event Details

How Does the Recent ICH-GCP E6 Update Affect YOU?

Sandra "SAM" Sather, MS, BSN, CCRA, CCRC, VP of Clinical Pathways, LLC

Discussion of the guideline updates, impact assessment, and a scalable approach to implementation

Purpose of ICH-GCP E6:

      Provides unified standard for: European Union, Japan, United States, Canada, and Switzerland

      Facilitate mutual acceptance by the regulatory authorities of data from clinical trials.

ICH-GCP E6 is in response to:

      Increase in scale, complexity, and cost of clinical trials

      Global Audit Findings

Focus of ICH-GCP E6:

      Updating and clarifying standards for electronic records and essential documents

      Encourage sponsors to implement improved oversight and management of clinical trials

      Facilitate innovative approaches (QRM, QbD, technology) to clinical trials

Join us for a stimulating presentation that analyzes the new guideline.

Learning Objectives:
1. Review the final updates to the ICH E6 (R2) GCP Guideline
2. Identify how the finalized ICH Guideline affects running clinical trials
3. Identify how the finalized ICH guideline affects sponsor oversight of the clinical trial

Speaker Bio:
Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).

Agenda:

6:00 – 6:45 PM   Registration, Networking, & Dinner Buffet

6:45 – 7:15 PM   President’s Welcome, Volunteer, and Sponsor Appreciation

7:15 – 8:15 PM   Educational Presentation

8:15 – 8.45 PM   Raffle, Open Mic, Networking 1:1 with speaker

Target Audience:  In collaboration with Bio2Devices.org 

  • Clinical Research Professionals

  • Sponsors, Study Sites, Physicians, Nurses

  • Vendors/Service Providers/CROs, Consultants

  • Institutional Review Boards

  • Related–Clinical Quality Assurance, Project Management, Account Rep, HR, Recruiters/Staffing, Finance, Biometrics, Regulatory and Students


EVENT REGISTRATION PURCHASE closes Thursday, June 8, at 11:59 PM Pacific Time

Walk-in registration: if seats available - add $5 to below registration fee:

  1. Northern California Chapter ACRP member   $5.00
  2. ACRP Member or Public $30

Bring your email confirmation to the event.  Please notify Event Manager of cancellation. No refunds or transfers.  

Event registration questions - Maria Filippou-Frye, Event Manager:   mariafilippoufrye@stanford.edu  

 

This event has been approved for 1.0 CONTACT HOURPlease click here to purchase contact hour.

Contact Hour Pricing:  NCC Member FREE;  ACRP Member $15;  Non-Member/Public $30

To receive contact hours: purchase after event registration and up to 14 days after the event;  sign-in at event and attend the program; go to http://www.acrpnet.org/, logon as member or guest, go to “Learning Portal” 1-30 days after the event to complete the evaluation and receive the certificate. 

ACRP contact hour purchase questions: chapters@acrpnet.org

ENTER TO WIN A $50 VISA Gift Card!

Test your knowledge on how the recent ICH-GCP E6 Update affects you. Click the link (below) and complete the survey by Thursday, June 8. Of those who complete the survey, one will be randomly selected to receive a $50 Visa gift card.

You must be present at the event to win.

http://www.surveygizmo.com/s3/3567884/How-Does-the-Recent-ICH-GCP-E6-Update-Affect-YOU

 

Funding and in-kind support provided by the following sponsors do not influence the content of this program.


Cepheid

 

UC Berkeley Extension


Please see our website for our calendar and more information  

                                                    acrpnet.org/NorthernCalifornia   or 

http://community.acrpnet.org/communities/community-home?CommunityKey=ec0f114b-f234-4c59-a9af-a659a6b1e8b8


Eventbrite flyer for June 15 event   v05.16.2017

Have questions about How Does the Recent ICH-GCP E6 Update Affect YOU?? Contact Northern California Chapter (SF Bay Area) - Association of Clinical Research Professionals (ACRP)

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When & Where


Cepheid
1315 Chesapeake Terrance
Building 5
Sunnyvale, CA 94089

Thursday, June 15, 2017 from 6:00 PM to 8:45 PM (PDT)


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Organizer

Northern California Chapter (SF Bay Area) - Association of Clinical Research Professionals (ACRP)

The Northern California Chapter (NCC) was founded in 1999 as an affiliate of the Association of Clinical Research Professionals (ACRP). Our mission is to serve Northern California clinical research professionals by providing professional development and networking opportunities in support of human subject protections in clinical research.

We offer high quality, zero - low-cost events, almost monthly and rotated around our region: Sacramento, North Bay, San Francisco – Palo Alto (Peninsula), Berkeley - east (East Bay), and Silicon Valley - San Jose (South Bay). Our annual program includes a Planning Meeting, several educational and networking events, and a year-end holiday educational event.  All events are open to the clinical research community.  We have ~275 members, the largest of all Chapters. We accomplish our robust program due to sponsorship and our volunteers.

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How Does the Recent ICH-GCP E6 Update Affect YOU?
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