Guest guest Posted August 23, 2005 Report Share Posted August 23, 2005 It would be wonderful if a bunch of our ladies could attend this conference! Thanks Lana, Cincinnati, OH - December 7 and 8. Rogene --- Lana Transue <lanadearest@...> wrote: > From: " Lana Transue " <lanadearest@...> > saxony01@... > Subject: FDA conference > Date: Mon, 22 Aug 2005 09:11:59 -0700 > > This is a conference that one of our ladies should > see if they can > participate in. > > > http://www.socra.org/FDA_Conference.htm > > FDA Clinical Trial Requirements Regulations, > Compliance, and GCP Conference > Dates, Location, Contact Information and Fees > > Conference Description > > Learning Objectives > > Conference Agenda > > Online Registration Form (Credit Card) > > Conference Registration Form (PDF) > > > > > Dates, Location, Contact Information, Fees, and > SoCRA Program Chairpersons > December 7 and 8, 2005 > Cosponsored with Cincinnati District, FDA > Westin, Cincinnati > 21 East Fifth Street > Cincinnati, OH 45202 > Phone (513) 621-7700 > Fax (513) 852-5670 > SoCRA Hotel room rate is $100 valid to November 6, > 2005 > > > The program moderator for the December conference > is: > Steve Eastham, Supervisory Consumer Safety Officer > Cincinnati District Office > 6751 Steger Drive > Cincinnati, OH 45237 > PHONE: (513) 679-2700, ext. 123 > > Back to Top > > > > Fees > $485 Member Fee (Non-Government Employee) > $560 Non-member Fee (Non-Government Employee) - > includes SoCRA annual > membership > $385 Member Fee (Government Employee) > $460 Non-member Fee (Government Employee) - includes > SoCRA annual membership > > Back to Top > > > > Conference Description > SoCRA is pleased to announce this conference that is > co-sponsored with the > Detroit District FDA. This conference on the FDA’s > clinical trial > requirements is designed to aid the Clinical > Research Professional’s > understanding of the mission, responsibilities, and > authority of the FDA, > and to facilitate interaction with FDA > representatives. > > This two-day conference is intended to share > information among FDA > representatives and the regulated community, to > facilitate the understanding > of regulations, guidelines and practices, and to > suggest methods and > opportunities to enhance the research professional’s > product development > experience. > > The program will focus on the relationships among > the FDA and clinical trial > staff, investigators and IRBs. The conference will > highlight three areas > that present challenges to sponsors and > investigational sites: > > FDA Clinical Research Requirements, > Enhancing Success through Communication and > Financial Incentives, > and Assuring Confidence in Clinical Research. > > Note: This course is accredited by SoCRA for 12 > Continuing Education Hours > for SoCRA CE and Nursing CE. > Nursing CE: SoCRA is approved as a provider of > continuing education in > nursing by the Pennsylvania State Nurses > Association, which is accredited as > an approver of continuing education in nursing by > the American Nurses > Credentialing Center’s Commission on Accreditation. > PSNA (ANA) Provider reference number 200-3-A-01 > SoCRA Course Number 03701 > > Back to Top > > > > Learning Objectives > Upon completion of the conference, the attendee > should be able to: Describe > what FDA Expects in a Pharmaceutical Clinical Trial > Discuss Adverse Event Reporting – Science, > Regulation, Error and Safety > Discuss Medical Device Aspects of Clinical Research > Explain Informed Consent Requirements > Discuss Current Ethical Issues in Subject Enrollment > Discuss IRB Regulations and FDA’s Mechanisms to > Assure Compliance > Describe FDA Inspections of Clinical Investigators > Explain Mechanisms for Keeping Informed and Making > Your Views Known to FDA > Discuss FDA’s Role in Maximizing Confi dence in the > Conduct of Clinical > Research > Explain Issues Involved in Managing Investigator > Initiated Research > Describe the Functioning of Pre IND Meetings and the > FDA Meeting Process > Explain How to Work with FDA’s Center for Biologics > Evaluation and Research > Discuss what happens when the Inspection is Over - > What Happens Next? > Possible FDA Enforcement Actions > > > Back to Top > > > > Conference Agenda > The Conference Agenda is available in Adobe PDF > format, which can be viewed > using the free-download of Adobe Acrobat Reader. > (Click Here to Download > this FREE software.) > > Click Here to view/print the January Conference > Agenda in Adobe PDF format. > > Click Here to view/print the April Conference Agenda > in Adobe PDF format. > > Back to Top > > > > Online Registration Form (Credit Card) > Click HERE to register online! > > Back to Top > > > > Conference Registration Form > The Conference Registration Form is available in > Adobe PDF format, which can > be viewed using the free-download of Adobe Acrobat > Reader. (Click Here to > Download this FREE software.) > > Click Here to view/print the January Conference > Registration Form in Adobe > PDF format. > > Click Here to view/print the April Conference > Registration Form in Adobe PDF > format > > > Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.