At the conclusion of this meeting, participants should be able to:
- Describe the current global regulatory framework for pharmacovigilance and the move towards harmonization
- Describe operational challenges of implementing global benefit-risk analyses and risk management plans
- Discuss how information technologies and social media are impacting pharmacovigilance
- Examine the role of epidemiology in safety analysis
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and the Drug Information Association. PIM is accredited by the ACCME to provide continuing medical education for physicians.
PIM designates this live activity for a maximum of 16.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program and applicable tutorial are designated for up to 10.5 contact hours or 1.05 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.
Corexcel is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.
Corexcel designates this activity for a maximum of 23 contact hours.
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; +1.703.506.3275.
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 2.3 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:
For more information go to www.diahome.org/certificateprograms
- Clinical Research Certificate Program: 12 Elective Units
- Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
- Regulatory Affairs Certificate Program: 12 Elective Units
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 Wednesday, January 29, 2014
The Postgraduate Institute for Medicine (PIM) and DIA require instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by PIM and DIA for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.
CONTINUING EDUCATION CREDIT ALLOCATION
Tutorial #1: Pharmacovigilance and Risk Management Planning: Pharmacy: 3.25 contact hours or .325 CEUs, 0286-0000-14-019-L04-P; Nursing: 3.25 contact hours; IACET: .3 CEUs
Tutorial #2: Introduction to Pharmacoepidemiology and Applications in Pre-Marketing and Post-Marketing Surveillance, Risk Management and Value Demonstration: Nursing: 3.25 contact hours; IACET: .3 IACET
Tutorial #3: ICH E2C (R2); The Quantum Leap from PSURs to Benefit Risk Evaluation (PBRERs): Nursing: 3.25 contact hours; IACET: .3 CEUs
Tutorial #4: Pharmacovigilance System Master File: Nursing: 3.25 contact hours; IACET: .3 CEUs
CME: 16.5 AMA PRA Category 1 Credit(s)TM
Nursing: 16.5 contact hours
IACET: 1.7 CEUs
Please be sure that DIA’s disclaimer, Grievance Policy, ADA statement and the learning objectives are also included.
- Session 1 - Keynote Presentation: Digital Disease Detection: 1.25 contact hours or .125 CEUs, 0286-0000-14-020-L04-P
- Session 7 – Benefit Risk and Risk Management: 1.5 contact hours or .15 CEUs, 0286-0000-14-021-L04-P
- Session 8 – Patient Perspective: 1.5 contact hour or .15 CEUs, 0286-0000-14-022-L04-P
- Session 9, Part II – Real World Evidence: Safety Applications: 1.5 contact hours or .15 CEUs, 0286-0000-14-023-L04-P
- Session 10, Session 10 – Social Media: 1.5 contact hours or .15 CEUs, 0286-0000-14-024-L04-P