Continuing Education Credits

DIA 2016 brings together key thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic organizations from around the globe - and across all disciplines involved in the discovery, development, and life cycle management of health care products. The DIA Annual Meeting is intended to strengthen professionals’ understanding of the value of cross-discipline integration and to foster innovation for better health outcomes.

Learning Objectives

At the conclusion of DIA 2016, participants should be able to:

Compare the current regional regulatory and public policy environment pertaining to pharmaceuticals and related products
Discuss the regulatory and economic factors that impact the global biopharmaceutical industry
Recognize the challenges facing regulatory agencies and industry in research study design and statistical methodology
Identify relevant data, document, and systems standards and integration approaches; explain their impact on quality and end to end efficiency in data collection, management, submission, and approval processes for medical products
Describe the current and future scope of innovative technology, including wearables and other mobile devices, in the generation and collection of electronic source data in clinical research and post-market assessment to improve patient outcomes
Discuss the role of big data and analytics, their applications throughout the product life cycle, and their ethical, legal, and security implications for patient data
Identify legal, advertising, and marketing issues related to providing product information
Apply principles of risk assessment and management to development and post-market phases of new health care products
Summarize issues in safety reporting and data analysis regarding adverse events
Distinguish regional approaches to integration of evidence-based medicine and comparative effectiveness research into health care decision making
Describe current issues in designing and implementing clinical trials, including patient recruitment, site selection, and management of multi-regional clinical trials
Identify current opportunities and challenges in the area of personalized medicine for disease treatment
Examine ways to provide appropriate support to the clinical trial process that will ultimately impact patient care

Specific learning objectives for each offering are found on the DIA 2016 website under the program description details and will be shown in all meeting rooms.

Select tutorials and program offerings (including sessions, forums, workshops, symposia) may be approved for AMA PRA Category 1 Credits™, pharmacy or nursing contact hours, or Project Management Institute professional development units (PDUs), or International Association for Continuing Education and Training continuing education units (CEUs). Continuing education credit information will be clearly identified in the final program and on the DIA 2016 website with the statement CME, Pharmacy, Nursing, or PMI PDUs. IACET continuing education units (CEUs) are offered for all program offerings except CE credits are NOT AVAILABLE for Track 20: Innovation Theater, Track 21: Poster Presentations, Track 22: Engage and Exchange, or Track 23: Opening Plenary.

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 (DIA). PIM is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

The Postgraduate Institute for Medicine designates this live activity for a maximum of 25.25 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)

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Participants can earn up to 22.5 contact hours or 2.25 continuing education units (CEUs) for participating in the Annual Meeting program offerings and conference tutorials, if applicable.

ACPE Credit Requests MUST BE SUBMITTED BY FRIDAY, AUGUST 12, 2016
DIA is required by the ACPE to report pharmacy-requested CEUs through the CPE Monitor. If ACPE credit requests are not submitted within date noted above, the ACPE credit request will not be processed to the CPE Monitor. 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 ID, please visit www.cpemonitor.net.

A complete listing of all designated Universal Activity Numbers (UANs) and Type of Activity are found here
American Nurses Credentialing Center (ANCC)
This educational activity for 25.25 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.
Project Management Institute (PMI)

DIA has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI).

Participants may receive up to 13 professional development units (PDUs) for attending the Annual Meeting program offerings and tutorial.

A complete listing of all PMI numbers are found here

The PMI Registered Education Provider logo is a registered mark of the Project Management Institute, Inc.
International Association for Continuing Education and Training (IACET)
DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET accredited provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer up to 2.6 CEUs for this program.

Continuing Legal Education

For attorneys who would like to receive continuing legal education credits for attending DIA 2016, please complete your state’s application for credit and submit accordingly. If you require additional information, please contact CE@DIAglobal.org

CE Credit Allocation

TUTORIALS – JUNE 26
Half Day Tutorials:
- 8:30 AM–12:00 PM: Up to: CME 3.25 AMA PRA Category 1 Credits™; IACET .3 CEUs; Nursing 3.25 contact hours; Pharmacy 3.25 contact hours or .325 CEUs; 3.25 PMI PDUs
- 1:00 PM–4:30 PM: Up to: CME 3.25 AMA PRA Category 1 Credits™; IACET .3 CEUs; Nursing 3.25 contact hours; Pharmacy 3.25 contact hours or .325 CEUs
Full Day Tutorials:
- 9:00 AM–5:00 PM: Up to: CME 6.5 AMA PRA Category 1 Credits™; IACET .7 CEUs; Nursing 6.5 contact hours; Pharmacy 6.5 contact hours or .65 CEUs
Annual Meeting Program Offerings – June 26-30

Credit amounts range based upon the amount of length of time for each offering from 1.75 hours, 1.5 hours, 1.25 hours, 1 hour, and .5 hour with the total amount of credit up to CME 18.5 AMA PRA Category 1 Credits™; 1.7 IACET CEUs (.2 IACET CEUs are offered for a 1.75 or 1.5 hour program offering and .1 IACET CEU is offered for a 1.25, 1, or .5 hour offering); Nursing 18.5 contact hours; Pharmacy 15.75 contact hours or 1.575 CEUs; 9.75 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: 12 Elective Units
- Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
- Project Management Certificate Program: 8 Elective Units
- Regulatory Affairs Certificate Program: 12 Elective Units
In addition, DIA’s Certificate Program units will be available for DIA 2016 tutorials. See specific units that are available for each offering noted on DIA 2016 website. For more information on DIA’s Certificate Program, visit DIAglobal.org/certificateprograms.

Participants who would like to receive continuing education credit for DIA 2016 must scan their DIA name badge at each offering to record their attendance. Participants must scan their badges within 45 minutes for the 1.5 hour offering, 30 minutes for the 1.25 and 1 hour offerings, and within 15 minutes for the 30 minute offering. Participants who do not scan their badges within the allotted time will not be eligible to request the available continuing education credits for that offering. If a participant attends multiple offerings within the same timeframe, only the last scanned entry will be recorded.

My Transcript Opens Tuesday, July 5

To access My Transcript:
- Visit DIAglobal.org, select “Sign in” and you will be prompted for your user ID and password
- Choose MENU, found in the upper left corner
- Under CONFERENCES select “Continuing Education"
- Select the blue “My Transcript” button followed by “Credit Request” to process your credit request for each offering and for each day of the meeting
Evaluation

DIA utilizes an online evaluation portal to allow participants to provide feedback on each offering. Complete details on how to access the evaluation portal will be included in the final program book. The evaluation portal closes on Thursday, July 28, 2016.
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 DIA. 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.
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. Disclosure statements will be included in the activity materials.
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.