Tutorial Learning Objectives:
At the conclusion of this tutorial, participants should be able to:
- Discuss the current regulatory/compliance environment pertaining to prescription drugs, biologics and medical devices, both from an FDA and OIG/DOJ perspective
- Describe the FDA advertising and promotional requirements, including such topics as: claim support requirements, fair balance expectations, internet challenges, product booths at medical conventions, disease state programs, and public relations challenges.
Tutorial, OPDP/APLB and Compliance 101: A Primer: IACET: .3 CEUs; Pharmacy: 3.25 contact hours or .325 CEUs, 0286-0000-13-006-L03-P
Conference Learning Objectives:
At the conclusion of this meeting, participants should be able to:
- Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
- Discuss how companies are complying with government marketing requirements
- Explain how to work collaboratively with those who review promotional materials
- Discuss the policies and actions being taken by OIG and DOJ under the False Claims Act
- Describe how to market products while complying with the FDA and other policies and regulations
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 14.5 contact hours or 1.45 continuing education units (CEU’s).
Type of Activity: Knowledge
ACPE Credit Request Update
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET),
1760 Old Meadow Road, Suite 500, McLean, VA 22102.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer up to 1.4 CEUs for the program. Participants must attend the entire program <and tutorial(s), if applicable> in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
DIA’s Certificate Program
This program is part of DIA’s Certificate Program and is awarded the following:
- Regulatory Affairs Certificate Program: 8 Elective Units
more information on DIA's Certificate Programs
If you would like to receive a statement of credit, you must attend the program (and tutorial, if applicable), scan your name badge at the DIA registration desk each day of the program, and complete the on-line credit request process through My Transcript
. To access My Transcript, please go to www.diahome.org
, select “Login to My DIA
” and you will be prompted for your user ID and password. Select “My Transcript
” (left side bar) and “Credit Request
” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Thursday, March 7, 2013.
It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
CONTINUING EDUCATION CREDIT ALLOCATION
IACET: 1.1 CEUs
Sessions 1 and 2: 3 contact hours or .3 CEUs, 0286-0000-13-007-L03-P
Sessions 3, 4, and 5: 3 contact hours or .3 CEUs, 0286-0000-13-008-L04-P
Breakout Session 1: 1.5 contact hours or .15 CEUs, 0286-0000-13-009-L04-P
Breakout Session 2: 1.5 contact hours or .15 CEUs, 0286-0000-13-010-L04-P
Break out Session 3: 1.5 contact hours or .15 CEUs, 0286-0000-13-011-L04-P
Breakout Session 1: 1.5 contact hours or .15 CEUs, 0286-0000-13-012-L04-P
Breakout Session 2: 1.5 contact hours or .15 CEUs, 0286-0000-13-013-L04-P
Break out Session 3: 1.5 contact hours or .15 CEUs, 0286-0000-13-014-L04-P
Sessions 8, 9, and Closing Remarks: 2.25 contact hours or .225 CEUs, 0286-0000-13-015-L04-P
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers, agenda, and CE information are subject to change without notice.
Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
DIA’s Grievance Policy.
AMERICANS WITH DISABILITIES ACT (ADA)
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact
the DIA office in writing at least 15 days prior to event to indicate your needs.