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Continuing Education

The DIA 2012 48th Annual Meeting is the premier event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. In an effort to streamline the program and focus on the hottest topics, this year’s program will offer 20 preconference tutorials and 20 content-area tracks comprising approximately 270 program offerings, with presentations geared to attendees of all disciplines, work settings, and experience levels.

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

TRACK 1: CLINICAL OPERATIONS

  • Recognize the current clinical trial challenges of costs, global execution and management by using innovative technologies and practices
  • Ensure ethical and safe treatment of subjects in the modern global trial arena

TRACK 2: PROJECT/PORTFOLIO MANAGEMENT AND STRATEGIC PLANNING

  • Identify project management and finance current trends, practices, and systems used in global product development, including strategic planning
  • Discuss portfolio asset strategy decision making, management, portfolio/product prioritization and optimization practices, including relevant methods and tools 
  • Describe quality design of clinical trials, complexity of study development, and building quality risk management into clinical trials

TRACK 3: INNOVATIVE PARTNERING MODELS AND OUTSOURCING STRATEGIES

  • Discuss innovative partnering models and unique outsourcing strategies that are shaping the way in which pharmaceutical and biotechnology companies work with Contract Research Organizations (CROs) and other service providers, academia, co-development partners, and other organizations

TRACK 4: NONCLINICAL AND TRANSLATIONAL DEVELOPMENT/EARLY PHASE CLINICAL DEVELOPMENT

  • Explain some of the latest nonclinical and clinical technologies and approaches for assessing the safety of pharmaceutical products
  • Discuss recent advances in coping with particularly challenging regulatory and scientific issues that arise in the early phases of novel pharmaceutical development 
  • List current strategies for designing successful early clinical pharmacology and experimental medicine trials

TRACK 5: PRODUCT ADVERTISING AND MARKETING

  • Discuss the current regulatory landscape related to drug advertising and promotion

TRACK 6: MEDICAL WRITING AND MEDICAL COMMUNICATIONS

  • Identify opportunities to collaborate and meet the expectations of multiple, global regulatory authorities, patients, payers, and other customers

TRACK 7: PROCESSES AND TECHNOLOGIES FOR CLINICAL RESEARCH

  • Describe how technologies and processes are used in clinical trials
  • Discuss how both technical and procedural innovations, including forward-thinking validation and qualification approaches, may transform the clinical trial life cycle in the future

TRACK 8: REGULATORY AFFAIRS AND SUBMISSIONS

  • Discuss the latest global regulatory trends and developments that impact the industry
  • Recognize key issues associated with evolving regulatory standards

TRACK 9: MEDICAL DIAGNOSTICS AND DEVICES

  • Identify opportunities for drug companies to address changing regulations in the area of medical devices, diagnostics, and drug/device combination products

TRACK 10: PUBLIC POLICY/HEALTH CARE COMPLIANCE REGULATORY LAW

  • Discuss implications and recommendations raised in health care compliance, public policy and regulatory law

TRACK 11: COMPLIANCE TO GOOD CLINICAL PRACTICE (GCP), GOOD LABORATORY PRACTICE (GLP), AND QUALITY ASSURANCE (QA)

  • Describe how to avoid GCP/GLP noncompliance through innovation and collaboration in a period of increasing complexity and globalization in clinical trials

TRACK 12: PHARMACEUTICAL QUALITY

  • Explain how to apply fundamental and advanced scientific and regulatory approaches to current and emerging pharmaceutical quality issues, including a strong emphasis on global harmonization efforts within and outside ICH

TRACK 13: HEALTH ECONOMICS AND OUTCOMES (HEO)/ COMPARATIVE EFFECTIVENESS RESEARCH (CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA)

  • Build the scientific capability to measure and communicate the medical need, health impact, and economic value associated with medical products
  • Describe the real-world use of Pharmacoeconomics & Outcomes Research (PEOR), Health Technology Assessments, Comparative Effectiveness, and Registries

TRACK 14: CLINICAL SAFETY AND PHARMACOVIGILANCE

  • Discuss a broad array of concepts and tools (traditional and new) that support participants’ pursuit of excellence in patient safety, for both investigational and marketed products

TRACK 15: STATISTICAL SCIENCE AND QUANTITATIVE THINKING

  • Identify innovative statistical solutions to issues associated with the evidence and regulatory review of drugs, diagnostics/devices, and biologics
  • Describe relevant application of statistical science and quantitative thinking to the development of new therapeutic biologics, drugs, and diagnostics/devices

TRACK 16: PROFESSIONAL DEVELOPMENT

  • Discuss ways to foster collaborative innovation through professional development and educational efforts

TRACK 17: GLOBAL REGULATORY

  • Discuss key initiatives, changes, and challenges of various global regulatory agencies with the review of drugs, diagnostics/devices, and biologics

TRACK 18: RARE/NEGLECTED DISEASES

  • Discuss key initiatives, development and strategies involving rare diseases, special populations and orphan drugs

TRACK 19: SIAC SHOWCASES

  • Discuss discipline-specific topics with a global community and share common experiences and knowledge with others in their particular field

TRACK 20: EXECUTIVE PROGRAM--PIONEERING PARTNERSHIPS

  • Discuss collaborative research with members of the payer community
  • Identify challenges of precision medicine associated with diagnostics, reimbursement and partnership co-development

TRACK 20: EXECUTIVE PROGRAM--PIONEERING PARTNERSHIPS

  • Discuss collaborative research with members of the payer community
  • Identify challenges of precision medicine associated with diagnostics, reimbursement and partnership co-development

TRACK 21: LATE-BREAKING HOT TOPICS

  • Hot topics will be announced in final program book

TRACK 22: WHITE PAPERs SHOWCASE

  • Describe stakeholder perceptions of risk—both real and perceived—that demonstrate a significant misalignment among biopharmaceutical stakeholders
  • Discuss how to incorporate remote monitoring into trial design and monitoring plans
  • Highlight the importance of establishing a quality control gateway between the medical writing community and regulatory affairs

Select tutorials and program offerings (including sessions, forums, workshops, symposia) have been approved for AMA PRA Category 1 Credits™ and will also offer pharmacy or nursing contact hours, or Project Management Institute (PMI) professional development units. Continuing education credit information will be clearly identified in the final program with the statement of CME, Pharmacy, Nursing, or PMI credits offered. IACET continuing education units (CEUs) are offered for all program offerings and tutorials. Continuing education credits are not available for the plenary session on Monday morning, company presentations, or white paper presentations. Learning objectives for each program offering (and tutorial, if applicable) will be shown in all meeting rooms.

  Accreditation and Credit Designation

PIM
Accreditation Council for Continuing Medical Education (ACCME)

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. 

The Postgraduate Institute for Medicine designates this live activity for a maximum of 25.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.


ACPE

Accreditation Council for Pharmacy Education (ACPE)

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants may earn up to 25.5 contact hours or 2.55 continuing education units (CEUs) for participating in the Annual Meeting program offerings and tutorials.


ANCC

American Nurses Credentialing Center (ANCC)
This educational activity for 25.5 contact hours is provided by PIM.

PIM is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. 

California Board of Registered Nursing
PIM is approved by the California Board of Registered Nursing, Provider Number 13485 for 25.5 contact hours.


PMI

Project Management Institute (PMI)
The Drug Information Association has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI). Participants may receive up to 25.5 professional development units (PDUs) for attending the Annual Meeting program offerings and tutorials.

The PMI Registered Education Provider logo is a registered mark of the Project Management Institute, Inc. 


IACET

International Association for Continuing Education and Training (IACET)
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 3.2 CEUs for this program




Continuing Legal Education

For attorneys who would like to receive continuing legal education credits for attending DIA 2012, 48th Annual Meeting, please complete your state’s application for credit and submit accordingly.

If you require additional information to complete your application, please contact Karen.Wetzel@diahome.org for assistance.

To Receive Continuing Education Credit

Program participants who would like to receive continuing education credits must attend the program, scan their DIA name badge at each offering to record his/her attendance, complete the online evaluation for each offering, and complete the online credit request process through My Transcript. Participants may scan their badges within 45 minutes of the start of each program offering (and tutorial, if applicable) time. Attendees who do not scan their badge within the allotted offering time will not be eligible to request the available continuing education credits for that event.

Participants will be able to download a statement of credit upon successful submission of the credit request. Complete details and instructions for accessing My Transcript will be included in the final program.


CE CREDIT ALLOCATION

Tutorials – June 24

Half-day tutorials:

(8:30 AM – 12:00 PM) Up to 3.25 AMA PRA Category 1 Credit(s)™, or 3.25 nursing contact hours, or .3 IACET CEUs

(1:00 – 4:30 PM) Up to 3.25 AMA PRA Category 1 Credit(s)™, or 3.25 pharmacy contact hours or .325 CEUs, or 3.25 nursing contact hours, or 3.25 PMI PDUs, or .3 IACET CEUs

Full-day tutorials:

Up to 6.5 AMA PRA Category 1 Credit(s)™, or 6.5 pharmacy contact hours or .65 CEUs, or 6.5 nursing contact hours, or 6.5 PMI PDUs, or .7 IACET CEUs

Annual Meeting Program Offerings – June 25-28

Up to 19 AMA PRA Category 1 Credit(s)™, or 19 pharmacy contact hours or 1.9 CEUs, or 19 nursing contact hours, or 19 PMI PDUs, or 2.5 IACET CEUs (up to 1.5 hours per program offering)

DIA Certificate Programs

Individuals enrolled in DIA Certificate Programs may receive elective units for the designated programs noted below:

  • Clinical Research Certificate Program: 14 Elective Units
  • Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
  • Project Management Certificate Program: 8 Elective Units
  • Regulatory Affairs Certificate Program: 14 Elective Units

In addition, elective units will be available for DIA 2012 tutorials. See specific units that are available for each offering noted in the preliminary program.

DISCLOSURE OF CONFLICTS OF INTEREST
Drug Information Association (DIA) and Postgraduate Institute for Medicine (PIM) requires 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 DIA and PIM for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

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)
DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs.

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