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Organization of Regulatory and Clinical Associates
Contact Information:
Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
(206)464-0825

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News

Live Webcast
The FDA is announcing the following public workshop entitled ‘‘Developing a Framework for Regulatory Use of Real-World Evidence.’’ Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making. Topics will include an update on FDA’s activities to address the use of RWE in regulatory decisions and the development of a framework for tackling challenges related to RWE’s regulatory acceptability. In addition, panelists will discuss opportunities to improve data development activities, study designs, and analytical methods used to create robust RWE.

The public workshop will be held on September 13, 2017, from 9 AM to 4:30 PM Eastern Time at the Conference Center at 1777 F Street NW., Washington, DC 20006. There will also be a live webcast for those unable to attend the meeting in person.

For additional information, please refer to the following Web site: https://healthpolicy.duke.edu/events/publicworkshop-developing-frameworkregulatory-use-real-world-evidence  



Membership Renewals 

All 2016-2017 memberships expired on July 31, 2017, but 2016-2017 members can still renew their expired memberships. 

Fees for the 2017-2018 membership year will remain the same and are as follows:

 

Regular Renewal Student/Government Renewal
$130 $80


For renewal instructions, see our FAQ page.



ORCA NEEDS YOUR HELP!
Volunteers are vital to ORCA’s success. Volunteers assist ORCA with its monthly programs, plan those programs and solicit speakers, develop and implement marketing efforts and membership drives, serve on its Board of Directors, and provide a wide range of volunteer services that help make ORCA a meaningful and useful resource for its members. Visit our Volunteering page to find out more about how you can help.


LifeScience Washington Programs




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Want to join ORCA or renew your expired membership?
All 2016-2017 memberships expired on July 31, 2017, but 2016-2017 members can still renew their expired memberships. For information on how to renew your expired membership or how to join ORCA as a new member, please visit our FAQ page.

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For more answers to frequently asked questions, please visit our FAQ page.



Knowledge Center

Useful FDA educational resources:


CDRH Learn

FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education

http://www.fda.gov/Training/CDRHLearn/

 

CDRH Medical Device Webinars and Stakeholder Calls

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm

 

CDER Learn

The web page for educational tutorials offered by the Center for Drug Evaluation and Research

http://www.fda.gov/Training/ForHealthProfessionals/

 

CDER Meetings, Conferences, & Workshops

http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm

 

CBER Sponsored Workshops, Meetings & Conferences

Upcoming events

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm280422.htm

Past events

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm280537.htm

 

OCTGT Learn

The Center for Biologics, Evaluation and Research's (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education.

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.htm


The Robert J. Margolis, M.D. Center for Health Policy
Calendar of Events