Continuing Education Credits
The DIA 2014 50th Annual Meeting is the premier event designed for individuals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related medical products. The Annual Meeting is intended to strengthen professionals’ understanding of the value of cross-discipline integration and to foster innovation for better health outcomes.
At the conclusion of the DIA 2014 50th Annual Meeting, participants should be able to:
TRACK 01: CLINICAL OPERATIONS
TRACK 02: PROJECT/PORTFOLIO MANAGEMENT AND STRATEGIC PLANNING
- Identify the important current clinical trial issues and how they can be addressed with innovative solutions
- Discuss methods of reducing costs while maintaining quality in the management of clinical trials using new technologies and efficient best practices
- Describe how to ensure ethical and safe treatment of subjects in the modern trial arena
- Identify and describe product development/project management practices and project-related finance practices used in industry and project management practices within regulatory agencies
- Discuss new project management practices and systems used in global product development
- Identify and describe product development portfolio management practices, portfolio asset strategy decision making methods, and associated tools
- Discuss new portfolio asset strategy decision making, management, and portfolio/product prioritization/optimization practices
- Discuss project and portfolio management practices for strategic planning
TRACK 03: INNOVATIVE PARTNERING MODELS AND OUTSOURCING STRATEGIES
- Identify 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 04: NONCLINICAL AND TRANSLATIONAL DEVELOPMENT/EARLY PHASE CLINICAL DEVELOPMENT
- Explain some of the latest nonclinical technologies and approaches for assessing the safety of pharmaceutical products
- Discuss recent advances in coping with particularly challenging issues that arise in the early phases of novel pharmaceutical development
- Describe current strategies for designing successful early clinical pharmacology and clinical trials
- Identify information needed to facilitate successful early interactions between regulatory agencies and other stakeholders such as key opinion leaders and patient advocacy groups
TRACK 05: REGULATION OF PRODUCT ADVERTISING AND MARKETING IN AN EVER-CHANGING WORLD
- Discuss the current regulatory landscape related to advertising and promotion
TRACK 06: MEDICAL COMMUNICATION, MEDICAL WRITING, AND MEDICAL SCIENCE LIAISON
- Identify opportunities to collaborate and meet the expectations of multiple, global regulatory authorities, health care professionals, patients, payers, and other customers
- Discuss successful communication channels across medical writing, medical communications and medical science liaisons
TRACK 07: PROCESSES AND TECHNOLOGIES FOR CLINICAL RESEARCH
- Discuss best practices for technologies and processes in clinical research
- Describe novel uses of existing/emerging technologies and processes
- Identify how technical and procedural innovations transform the clinical trials life cycle
TRACK 08: REGULATORY AFFAIRS AND SUBMISSIONS
- Discuss the latest global regulatory trends and developments that impact the industry
TRACK 09: MEDICAL DEVICES, IN VITRO DEVICES, IN VITRO DIAGNOSTICS, AND COMBINATION PRODUCTS
- Discuss how to further enhance the abilities of drug companies to meet the regulatory challenges created by innovate drug delivery, companion diagnostics and personalized medicine
TRACK 10: PUBLIC POLICY/HEALTH CARE COMPLIANCE/LAW
- Discuss implications and recommendations raised in current topics in health care compliance, public policy, and law
TRACK 11: INNOVATIVE APPROACHES TO ENSURING QUALITY IN CLINICAL TRIALS AND COMPLIANCE TO GOOD CLINICAL PRACTICE (GCP)
- Describe innovative approaches being used to manage GCP compliance and ensure quality in the development of new therapeutics in a changing international regulatory landscape
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 the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
TRACK 13: COMPARATIVE EFFECTIVENESS RESEARCH/GLOBAL HEALTH OUTCOMES AND ECONOMICS
- Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical interventions
- Evaluate treatment heterogeneity and comparative effectiveness research (methods and applications)
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 health care products
TRACK 15: STATISTICAL SCIENCE AND QUANTITIVE 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 advancing therapeutic innovation and regulatory science through professional development and educational efforts
TRACK 17: RARE/ORPHAN DISEASES
- Identify the unique challenges, opportunities, and strategies that will help to shape a better future for the successful discovery and development of orphan drugs and novel treatments for rare diseases
- Examine the role of basic, translational, and clinical researchers, drug/device companies, governmental agencies, patient advocacy organizations and patients in novel therapy development
- Recognize the impact of rare/orphan diseases on patient well-being and health care systems
TRACK 18: GLOBAL REGULATORY
- Discuss key initiatives, changes, and challenges of various global regulatory agencies with the review of drugs, diagnostics/devices, and biologics
Select tutorials and program offerings (including sessions, forums, workshops, symposia, TURBO
offerings) have been approved for AMA PRA Category 1 Credits
™ and may also offer pharmacy or nursing contact hours, or Project Management Institute (PMI) professional development units (PDUs). Continuing education credit information will be clearly identified in the final program with the statement of CME, Pharmacy, Nursing, or PMI PDUs. IACET continuing education units (CEUs) are offered for all program offerings and tutorials. Continuing education credits are not available
for the Opening Plenary Session on Monday afternoon, Power Up! session on Tuesday afternoon, Student or Professional Poster Sessions, or Innovation Theater. Learning objectives for each program offering (and tutorial, if applicable) will be shown in all meeting rooms.
ACCREDITATION AND CREDIT DESIGNATION STATEMENTS
Accreditation Council for Continuing Medical Education (ACCME)
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership 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 24.5 AMA PRA Category 1 Credits
™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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 24.5 contact hours or 2.45 continuing education units (CEUs) for participating in the Annual Meeting program offerings and tutorials.
ACPE Credit Requests
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor. 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
. All ACPE credit requests made after the 45-day post activity (Thursday, July 31, 2014) may not be accepted by ACPE through the CPE Monitor. It is the pharmacists responsibility to request ACPE credit within the required time.
American Nurses Credentialing Center (ANCC)
This educational activity for 24.5 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 24.5 contact hours.
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). PMI #: 2166-000160
Participants may receive up to 18.25 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.
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).
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 3.1 CEUs for this program.
Continuing Legal Education
For attorneys who would like to receive continuing legal education credits for attending DIA 2014 50th 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 Tenaglia at Karen.Tenaglia@diahome.org
CE CREDIT ALLOCATION
TUTORIALS – June 15
Half Day tutorials:
- 8:30 AM – 12:00 PM: Up to CME 3.25 AMA PRA Category 1 CreditsTM; or IACET .3 CEUs; or Nursing 3.25 contact hours; or 3.25 PMI PDUs
- 1:00 PM – 4:30 PM: Up to CME 3.25 AMA PRA Category 1 CreditsTM; or IACET .3 CEUs; or Nursing 3.25 contact hours; or Pharmacy 3.25 contact hours or .325 CEUs
Full Day tutorials:
ANNUAL MEETING PROGRAM OFFERINGS – June 16-19
- 9:00 AM – 5:00 PM: Up to CME 6.5 AMA PRA Category 1 CreditsTM; or IACET .7 CEUs; or Nursing 6.5 contact hours; or Pharmacy 6.5 contact hours or .65 CEUs
Up to CME 18 AMA PRA Category 1 Credit(s)
™; or IACET 2.4 CEUs (.2 IACET CEUs are offered for 1.5 hour offerings and .1 IACET CEU is offered for 1 hour TURBO
offerings); Nursing 18 contact hours; or Pharmacy 18 contact hours or 1.8 CEUs; or 15 PMI PDUs
DIA Certificate Programs
Individuals enrolled in DIA Certificate Programs may receive elective units for the designated programs noted below:
- Clinical Research Certificate Program
- Clinical Safety and Pharmacovigilance Certificate Program
- Project Management Certificate Program
- Regulatory Affairs Certificate Program
12 Elective Units
4 Elective Units
8 Elective Units
12 Elective Units
In addition, elective units will be available for DIA 2014 50th Annual Meeting tutorials. See specific units that are available for each offering noted in preliminary program book. View more information on DIA’s Certificate Programs.
STATEMENT OF CREDIT
Participants who would like to receive continuing education credits for the DIA 2014 50th Annual Meeting must scan their DIA name badge at each program offering to record their attendance and complete each program offering evaluation form. Participants must scan their badges within 45 minutes after the start of each 1.5 hours program offering and within 30 minutes after the start time for the 1 hour TURBO
offering. Attendees who do not scan their badges within the allotted time will not be eligible to request the available continuing education credits for that program offering. If a participant attends multiple program offerings within the same timeframe, only the last scanned entry within the time frame listed above will be
To request a statement of credit, 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” for each program offering. My Transcript will open on Tuesday, June 24, 2014
Reminder — All ACPE credit requests must be submitted by Thursday, July 31. If you experience any difficulties, please contact DIA at firstname.lastname@example.org
Access to DIA 2014 50th Annual Meeting online evaluations are found at www.diahome.org/DIA2014evals. At the end of each day, all participant scanned data will be uploaded and only the offerings you attended will appear.
Complete your scanned offerings evaluations and be entered to win great prizes! DIA will randomly select three winners who have completed all scanned offerings evaluations for each day of the Annual Meeting to win one of the following prizes:
- Free registration for the DIA 2015 51st Annual Meeting, Washington D.C.
- Microsoft Surface
- Apple iPad Mini
During the week of July 21, the three drawings will take place and the winners will be notified by email.
DISCLOSURE OF CONFLICTS OF INTEREST
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.
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
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.
Any questions regarding continuing education please email Karen.Tenaglia@diahome.org.