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Continuing Education

Learning Objectives

At the conclusion of this meeting, participants should be able to:

  • Describe the current regulatory framework for pharmacovigilance in the US, Europe, Japan, China, Brazil and Canada
  • Describe operational challenges of implementing global benefit-risk analyses and risk management plans
  • Discuss how social media is impacting pharmacovigilance
  • Examine the role of epidemiology in safety analysis
Tutorial Descriptions and Learning Objectives:

Tutorial #1 - Pharmacovigilance and Risk Management Planning
This tutorial will focus on the practical aspects of managing biopharmaceutical product risks in the context of a product’s benefits.

At the conclusion of this activity, participants should be able to:

  • Discuss similarities and differences in risk management planning in the three ICH regions
  • Describe the differences between important identified risks and important potential risks
  • Outline the basic structure and contents of an EU Risk Management Plan (in the context of a Risk Management System) and a Risk Evaluation and Mitigation Strategy (REMS)
  • Discuss primary tools for managing product risks, how the effectiveness of a selected tool is assessed, and triggers for modification or removal of a given intervention
Tutorial #2 - Development Safety Update Reports (DSURs): Principles and Practicalities
The new ICH E2F guideline on the Development Safety Update Report (DSUR) was signed off in August 2010 and came into force in Europe in September 2011. This new report will replace the current European clinical trial Annual Safety Report and, in the other ICH regions is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study.

At the conclusion of this activity, participants should be able to:

  • Discuss the main principles defined in the ICH E2F guideline
  • Describe the structure and content of the DSUR
  • Discuss how a DSUR can be prepared
  • Review the implementation process of the DSUR
Tutorial #3 -ICH E2C (R2); The Quantum Leap from PSURs to Benefit Risk Evaluation (PBRERs)
The new ICH E2C (E2C) guideline on Periodic Benefit Risk Evaluation Reports reached Step 2 in February 2012 with the aim to complete Step 4 in November 2012. Already implemented in the EU under the new Pharmacovigilance legislation, this new report represents a significant change from the previous PSUR format and a quantum leap forward towards a document incorporating many new concepts including an integrated evaluation of both benefits and risks of a medicinal product. In the other ICH regions, the PBRER is intended to replace existing requirements for post marketing periodic reporting.

At the conclusion of this activity, participants should be able to:

  • Discuss the main principles defined in the ICH E2C (R2) guideline
  • Describe the structure and content of the new PBRER
  • Explain regulatory authority expectations of the PBRER
  • Recognize how to implement the PBRER to encompass multiple functions
  • Discuss the practical aspects of preparation of the PBRER
Tutorial #4 - Pharmacovigilance System Master File
As part of the new EU Pharmacovigilance Legislation (Regulation EU 1235/2010 and Directive 2010/84/EU) marketing-authorisation holders are required to maintain a Pharmacovigilance System Master File (PSMF). The PSMF must be in place at the time of initial marketing authorization application, license renewal and available for inspections. The PSMF replaced the Detailed Description of the Pharmacovigilance System (DDPS). This tutorial will cover the requirements in the PSMF, the creation and maintenance as well as sharing a real experience focusing on some of challenges and how they can be addressed.

At the conclusion of this activity, participants should be able to:

  • Discuss how to prepare a PSMF to meet the requirements
  • Describe how to maintain a PSMF so that it can be available within seven days from request
  • Examine challenges and possible scenarios of how to address preparation and maintenance

PIMThis 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.


ACPEThe 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 9.25 contact hours or .925 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 http://www.nabp.net/.


ANCCCorexcel 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.

 


IACETDrug 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 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:

  • Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
Read 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 Wednesday, January 30, 2013.

Disclosure Policy


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, 0286-0000-13-001-L04-P; Nursing: 3.25 contact hours; IACET: .3 CEUs

Tutorial #2, Development Safety Update Reports (DSURs): Principles and Practicalities: Nursing: 3.25 contact hours; IACET: .3 CEUs

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

Program 

CME: 16.5 AMA PRA Category 1 Credit(s)TM

Nursing: 16.5 contact hours

IACET: 1.7 CEUs

Pharmacy: Total 6 contact hours or .6 CEUs, see Pharmacy Credit Allocation below:
Session 2 – FDA Updates: 1.5 contact hours or .15 CEUs, 0286-0000-13-002-L04-P
Session 4 – Debate: Controversies in Pharmacovigilance – Blind or Unblind: 1.5 contact hours or .15 CEUs, 0286-0000-13-003-L04-P
Session 10 – Epidemiology: 1.5 contact hours or .15 CEUs, 0286-0000-13-004-L04-P
Session 11 – Social Media Panel Discussion: 1.5 contact hours or .15 CEUs, 0286-0000-13-005-L04-P

Disclaimer
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.

View 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.
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