United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-02-15 article Notices D09002ee1c7fd703d D09002ee1c7fd70da United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800-606-7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: http:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled). 77 FR 8886 https://www.govinfo.gov/app/details/FR-2012-02-15/2012-3553 2012-3553 fr15fe12-108 4160-01-P Docket No. FDA-2012-N-0001 https://www.govinfo.gov/app/details/FR-2012-02-15/2012-3553 https://www.govinfo.gov/content/pkg/FR-2012-02-15/html/2012-3553.htm https://www.govinfo.gov/content/pkg/FR-2012-02-15/pdf/2012-3553.pdf 2 p. 8886 8887 77 FR 8886 Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Federal Register Vol. 77, Issue NOTICE 2012-3553 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0001 4160-01-P 2012-3553 Notice of public workshop.

The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800-606-7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: http:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled).

Workshops: Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice , nancy.bellamy@fda.hhs.gov SoCRAmail@aol.com http://www.SoCRA.org http://www.socra.org/html/FDA_Conference.htm Vol. 77, no. 31 Office of the Federal Register, National Archives and Records Administration 2012-02-15 continuing daily deposited born digital 455 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-02-15 P0b002ee181e5d26a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr15fe12 https://www.govinfo.gov/app/details/FR-2012-02-15 https://www.govinfo.gov/content/pkg/FR-2012-02-15/pdf/FR-2012-02-15.pdf https://www.govinfo.gov/content/pkg/FR-2012-02-15/xml/FR-2012-02-15.xml fdlp 8717 9161 DGPO 2012-02-15 2024-06-03 FR-2012-02-15 machine generated eng FR FR-2012-02-15 77 31