80_FR_18478 80 FR 18413 - Society of Clinical Research Associates-Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice [email protected], 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.) Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member, $575; SOCRA nonmember (includes membership), $650; Federal Government member, $450; Federal Government nonmember, $525; FDA employee, free (fee waived). If you need special accommodations due to a disability, please contact SOCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physicians Recognition Award Category 1 Credit(s)<SUP>TM</SUP>. Physicians should claim only the credit commensurate with the extent of their participation. Continuing Medical Education for physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for nurses: SOCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To register via the Internet, go to http://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see Contact)."> [email protected], 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.) Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member, $575; SOCRA nonmember (includes membership), $650; Federal Government member, $450; Federal Government nonmember, $525; FDA employee, free (fee waived). If you need special accommodations due to a disability, please contact SOCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physicians Recognition Award Category 1 Credit(s)<SUP>TM</SUP>. Physicians should claim only the credit commensurate with the extent of their participation. Continuing Medical Education for physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for nurses: SOCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To register via the Internet, go to http://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see Contact)." /> [email protected], 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.) Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member, $575; SOCRA nonmember (includes membership), $650; Federal Government member, $450; Federal Government nonmember, $525; FDA employee, free (fee waived). If you need special accommodations due to a disability, please contact SOCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physicians Recognition Award Category 1 Credit(s)<SUP>TM</SUP>. Physicians should claim only the credit commensurate with the extent of their participation. Continuing Medical Education for physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for nurses: SOCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To register via the Internet, go to http://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see Contact)." />

80 FR 18413 - Society of Clinical Research Associates-Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 65 (April 6, 2015)

Page Range18413-18413
FR Document2015-07810

The Food and Drug Administration (FDA) is announcing an educational conference cosponsored with the Society of Clinical Research Associates (SOCRA). The public conference regarding 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 (IRBs). Individual FDA representatives will discuss the informed consent process including informed consent documents, regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors. Date and Time: The public conference will be held on May 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The conference will be held at The Westin Cincinnati, 21 East Fifth Street, Cincinnati, OH 45202; 513-621-7700. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $169 plus applicable taxes (available until April 15, 2015, or until the SOCRA room block is filled). Contact: John Fraser, Cincinnati District Office, Food and Drug Administration, 6751 Steger Dr., Cincinnati OH 45237, 513-679-2700, FAX: 513-679-2771 or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 215-822-8644, FAX: 215-822-8633, email: [email protected], 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.) Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member, $575; SOCRA nonmember (includes membership), $650; Federal Government member, $450; Federal Government nonmember, $525; FDA employee, free (fee waived). If you need special accommodations due to a disability, please contact SOCRA (see Contact) at least 21 days in advance. Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this live activity for a maximum of 13.3 American Medical Association Physicians Recognition Award Category 1 Credit(s)<SUP>TM</SUP>. Physicians should claim only the credit commensurate with the extent of their participation. Continuing Medical Education for physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for nurses: SOCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To register via the Internet, go to http://www.socra.org/html/ FDA_Conference.htm. Payment by major credit card is accepted (Visa/ MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see Contact).

Federal Register, Volume 80 Issue 65 (Monday, April 6, 2015) 
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Page 18413]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Society of Clinical Research Associates--Food and Drug 
Administration Clinical Trial Requirements, Regulations, Compliance and 
Good Clinical Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
educational conference cosponsored with the Society of Clinical 
Research Associates (SOCRA). The public conference regarding 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 (IRBs). Individual FDA representatives will discuss the informed 
consent process including informed consent documents, regulations 
relating to drugs, devices, and biologics, as well as inspections of 
clinical investigators, IRBs, and research sponsors.
    Date and Time: The public conference will be held on May 13 and 14, 
2015, from 8 a.m. to 5 p.m.
    Location: The conference will be held at The Westin Cincinnati, 21 
East Fifth Street, Cincinnati, OH 45202; 513-621-7700. Attendees are 
responsible for their own accommodations. Please mention SOCRA to 
receive the hotel room rate of $169 plus applicable taxes (available 
until April 15, 2015, or until the SOCRA room block is filled).
    Contact: John Fraser, Cincinnati District Office, Food and Drug 
Administration, 6751 Steger Dr., Cincinnati OH 45237, 513-679-2700, 
FAX: 513-679-2771 or Society of Clinical Research Associates (SOCRA), 
530 West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 
215-822-8644, FAX: 215-822-8633, email: [email protected], 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.)
    Registration: The registration fee will cover actual expenses 
including refreshments, lunch, materials, and speaker expenses. Seats 
are limited; please submit your registration as soon as possible. 
Workshop space will be filled in order of receipt of registration. 
Those accepted into the workshop will receive confirmation. The cost of 
the registration is as follows: SOCRA member, $575; SOCRA nonmember 
(includes membership), $650; Federal Government member, $450; Federal 
Government nonmember, $525; FDA employee, free (fee waived).
    If you need special accommodations due to a disability, please 
contact SOCRA (see Contact) at least 21 days in advance.
    Extended periods of question and answer and discussion have been 
included in the program schedule. SOCRA designates this education 
activity for a maximum of 13.3 Continuing Education (CE) Credits for 
SOCRA CE and Continuing Nurse Education (CNE). SOCRA designates this 
live activity for a maximum of 13.3 American Medical Association 
Physicians Recognition Award Category 1 Credit(s)TM. 
Physicians should claim only the credit commensurate with the extent of 
their participation. Continuing Medical Education for physicians: SOCRA 
is accredited by the Accreditation Council for Continuing Medical 
Education to provide continuing medical education for physicians. CNE 
for nurses: SOCRA is an approved provider of continuing nursing 
education by the Pennsylvania State Nurses Association (PSNA), an 
accredited approver by the American Nurses Credentialing Center's 
Commission on Accreditation(ANCC). ANCC/PSNA Provider Reference Number: 
205-3-A-09.
    Registration Instructions: To register, please submit a 
registration form with your name, affiliation, mailing address, 
telephone, fax number, and email, along with a check or money order 
payable to ``SOCRA''. Mail to: SOCRA (see Contact for address). To 
register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. Payment by major credit card is accepted (Visa/
MasterCard/AMEX only). For more information on the meeting 
registration, or for questions on the workshop, contact SOCRA (see 
Contact).

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. The workshop will provide those engaged in 
FDA-regulated (human) clinical trials with information on a number of 
topics concerning FDA requirements related to informed consent, 
clinical investigation requirements, institutional review board 
inspections, electronic record requirements, and investigator-initiated 
research.
    Topics for discussion include the following: (1) The Role of the 
FDA District Office Relative to the Bioresearch Monitoring Program; (2) 
Modernizing FDA's Clinical Trials/BIMO Programs; (3) What FDA Expects 
in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects of 
Clinical Research; (5) Adverse Event Reporting--Science, Regulation, 
Error and Safety; (6) Working with FDA's Center for Biologics 
Evaluation and Research; (7) Ethical Issues in Subject Enrollment; (8) 
Keeping Informed and Working Together; (9) FDA Conduct of Clinical 
Investigator Inspections; (10) Investigator Initiated Research; (11) 
Meetings with the FDA--Why, When, and How; (12) Part 11 Compliance--
Electronic Signatures; (13) IRB Regulations and FDA Inspections; (14) 
Informed Consent Regulations; (15) The Inspection is Over--What Happens 
Next? Possible FDA Compliance Actions; (16) Question and Answer 
Session/Panel Discussion.
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the quality of FDA-regulated 
drugs and devices. The workshop helps to achieve objectives set forth 
in section 406 of the Food and Drug Administration Modernization Act of 
1997 (21 U.S.C. 393), which includes working closely with stakeholders 
and maximizing the availability and clarity of information to 
stakeholders and the public. The workshop also is consistent with the 
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 
104-121), as outreach activities by Government agencies to small 
businesses.

    Dated: April 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07810 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18413 Notice of this meeting is given under 215–822–8644, FAX: 215–822–8633, SUPPLEMENTARY INFORMATION: The the Federal Advisory Committee Act (5 email: Office@socra.org, Web site: public workshop helps fulfill the U.S.C. app. 2). http://www.socra.org. (FDA has verified Department of Health and Human Dated: March 31, 2015. the Web site addresses throughout this Services’ and FDA’s important mission Leslie Kux, document, but we are not responsible to protect the public health. The for any subsequent changes to the Web workshop will provide those engaged in Associate Commissioner for Policy. sites after this document publishes in FDA-regulated (human) clinical trials [FR Doc. 2015–07816 Filed 4–3–15; 8:45 am] the Federal Register.) with information on a number of topics BILLING CODE 4164–01–P Registration: The registration fee will concerning FDA requirements related to cover actual expenses including informed consent, clinical investigation refreshments, lunch, materials, and DEPARTMENT OF HEALTH AND speaker expenses. Seats are limited; requirements, institutional review board HUMAN SERVICES please submit your registration as soon inspections, electronic record as possible. Workshop space will be requirements, and investigator-initiated Food and Drug Administration research. filled in order of receipt of registration. [Docket No. FDA–2015–N–0001] Those accepted into the workshop will Topics for discussion include the receive confirmation. The cost of the following: (1) The Role of the FDA Society of Clinical Research registration is as follows: SOCRA District Office Relative to the Associates—Food and Drug member, $575; SOCRA nonmember Bioresearch Monitoring Program; (2) Administration Clinical Trial (includes membership), $650; Federal Modernizing FDA’s Clinical Trials/ Requirements, Regulations, Government member, $450; Federal BIMO Programs; (3) What FDA Expects Compliance and Good Clinical Practice Government nonmember, $525; FDA in a Pharmaceutical Clinical Trial; (4) employee, free (fee waived). Medical Device Aspects of Clinical AGENCY: Food and Drug Administration, If you need special accommodations HHS. due to a disability, please contact Research; (5) Adverse Event Reporting— ACTION: Notice of public conference. SOCRA (see Contact) at least 21 days in Science, Regulation, Error and Safety; advance. (6) Working with FDA’s Center for SUMMARY: The Food and Drug Extended periods of question and Biologics Evaluation and Research; (7) Administration (FDA) is announcing an answer and discussion have been Ethical Issues in Subject Enrollment; (8) educational conference cosponsored included in the program schedule. Keeping Informed and Working with the Society of Clinical Research SOCRA designates this education Together; (9) FDA Conduct of Clinical Associates (SOCRA). The public activity for a maximum of 13.3 Investigator Inspections; (10) conference regarding FDA’s clinical trial Continuing Education (CE) Credits for Investigator Initiated Research; (11) requirements is designed to aid the SOCRA CE and Continuing Nurse Meetings with the FDA—Why, When, clinical research professional’s Education (CNE). SOCRA designates and How; (12) Part 11 Compliance— understanding of the mission, this live activity for a maximum of 13.3 Electronic Signatures; (13) IRB responsibilities, and authority of FDA American Medical Association Regulations and FDA Inspections; (14) and to facilitate interaction with FDA Physicians Recognition Award Category Informed Consent Regulations; (15) The representatives. The program will focus 1 Credit(s)TM. Physicians should claim Inspection is Over—What Happens on the relationships among FDA and only the credit commensurate with the clinical trial staff, investigators, and Next? Possible FDA Compliance extent of their participation. Continuing Actions; (16) Question and Answer institutional review boards (IRBs). Medical Education for physicians: Individual FDA representatives will Session/Panel Discussion. SOCRA is accredited by the discuss the informed consent process Accreditation Council for Continuing FDA has made education of the drug including informed consent documents, Medical Education to provide and device manufacturing community a regulations relating to drugs, devices, continuing medical education for high priority to help ensure the quality and biologics, as well as inspections of physicians. CNE for nurses: SOCRA is of FDA-regulated drugs and devices. clinical investigators, IRBs, and research an approved provider of continuing The workshop helps to achieve sponsors. nursing education by the Pennsylvania objectives set forth in section 406 of the Date and Time: The public conference State Nurses Association (PSNA), an Food and Drug Administration will be held on May 13 and 14, 2015, accredited approver by the American Modernization Act of 1997 (21 U.S.C. from 8 a.m. to 5 p.m. Nurses Credentialing Center’s 393), which includes working closely Location: The conference will be held Commission on Accreditation(ANCC). with stakeholders and maximizing the at The Westin Cincinnati, 21 East Fifth ANCC/PSNA Provider Reference availability and clarity of information to Street, Cincinnati, OH 45202; 513–621– Number: 205–3–A–09. stakeholders and the public. The 7700. Attendees are responsible for their Registration Instructions: To register, workshop also is consistent with the own accommodations. Please mention please submit a registration form with Small Business Regulatory Enforcement SOCRA to receive the hotel room rate of your name, affiliation, mailing address, Fairness Act of 1996 (Pub. L. 104–121), $169 plus applicable taxes (available telephone, fax number, and email, along until April 15, 2015, or until the SOCRA with a check or money order payable to as outreach activities by Government room block is filled). ‘‘SOCRA’’. Mail to: SOCRA (see Contact agencies to small businesses. Contact: John Fraser, Cincinnati for address). To register via the Internet, Dated: April 1, 2015. tkelley on DSK4VPTVN1PROD with NOTICES District Office, Food and Drug go to http://www.socra.org/html/FDA_ Leslie Kux, Administration, 6751 Steger Dr., Conference.htm. Payment by major Associate Commissioner for Policy. Cincinnati OH 45237, 513–679–2700, credit card is accepted (Visa/ [FR Doc. 2015–07810 Filed 4–3–15; 8:45 am] FAX: 513–679–2771 or Society of MasterCard/AMEX only). For more BILLING CODE 4164–01–P Clinical Research Associates (SOCRA), information on the meeting registration, 530 West Butler Ave., Suite 109, or for questions on the workshop, Chalfont, PA 18914, 800–762–7292 or contact SOCRA (see Contact). VerDate Sep<11>2014 18:14 Apr 03, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 E:\FR\FM\06APN1.SGM 06APN1


Document Created: 2015-12-18 11:18:14
Document Modified: 2015-12-18 11:18:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public conference.
FR Citation80 FR 18413 
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